1. Maureen McCartney Mary Loughrey Richard Smithson
Changes to Childhood Immunisation Schedule – the introduction of Rotavirus vaccine (Rotarix®) and Changes to the Meningococcal C Schedule
Maureen McCartney
Mary Loughrey
Richard Smithson
Background
As you will be aware, a number of changes to the immunisation programme in Northern Ireland will be taking place over the coming months. These reflect recommendations made by the Joint Committee on Vaccination and Immunisation (JCVI), the independent expert advisory group on vaccines for the UK. The changes will be introduced in the other parts of the UK as well.
These include the introduction of a new oral vaccine into the infant immunisation schedule to protect infants against rotavirus. Rotavirus is the commonest cause of gastroenteritis among young children and results in a significant number of young children being admitted to hospital each year.
They also include changes to the Men C vaccine schedule. Both of these will be covered today.
Other changes are the phased introduction of flu vaccine for all children aged 2 – 16 years inclusive and shingles vaccine for older people. They will be covered by training in a couple of months time as they are being introduced slightly later.
Rationale of resource
This resource is designed to support registered healthcare practitioners involved in discussing vaccination with parents/guardians and providing them with evidence based information about vaccination against rotavirus and guidance on the administration of this new vaccine and the evidence base and details of the new Men C vaccine schedule.

2. Acknowledgment
This resource was prepared by Health Protection Scotland (Rotavirus Vaccine) and the Vaccine Preventable Disease Programme, Public Health Wales (Men C Vaccine), and adapted for use in Northern Ireland by the Public Health Agency.
We gratefully acknowledge their work and their permission to adapt it for use in Northern Ireland.

3. Content of Presentation.
Rotavirus Vaccine
What is rotavirus?
Why vaccinate against rotavirus?
Vaccination against rotavirus – the use of Rotarix®
The role of registered healthcare practitioners
Resources
Men C Vaccine
What is Meningococcal serogroup C disease?
What, why and when are the changes happening?
Which vaccines are recommended?
The role of the HCP. Resources

4. Rotavirus Vaccine

5. Key Message
Rotavirus is the most common cause of gastroenteritis in young children. Most children will experience at least one infection with rotavirus by the time they are five years old, with some requiring hospitalisation for dehydration.
An oral vaccine against rotavirus is being introduced into the infant immunisation programme at the 2 and 3 month appointments.
Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children

6. Aims of resource
To support staff involved in discussing vaccination against rotavirus with parents/carers by providing evidence based information.
To raise awareness of rotavirus epidemiology and the benefits of rotavirus vaccination for young infants.
To provide guidance on the administration of this new oral vaccine, including how to administer the vaccine, contraindications, precautions and potential adverse reactions.
The key roles of registered healthcare practitioners in relation to vaccination against rotavirus:
To advise parents/carers that it is strongly recommended that their infant is vaccinated against rotavirus
Explain what rotavirus infection is, its potential complications and that vaccination will provide protection to young infants against the main strains of rotavirus
Explain which vaccine will be used, the contraindications and possible side effects to vaccination and the evidence for this new vaccination programme.
To safely administer this new oral vaccine to young infants
To ensure vaccination is administered according to the schedule
To ensure any adverse events are managed and reported appropriately
To ensure vaccination is recorded appropriately, along with other infant immunisations.

7. Learning outcomes
After completing this resource registered healthcare practitioners will be able to:
Describe the aetiology and epidemiology of rotavirus
Have an understanding of how rotavirus is transmitted and the potential complications of infection in infants
Discuss the importance of vaccination against rotavirus
Have a knowledge of the contraindications for rotavirus vaccination
Safely administer the vaccine
Have an understanding of potential adverse reactions and how to report these
Be aware of sources of additional information

8. What is rotavirus?
Rotavirus is a virus that causes gastroenteritis in particular in infants and young children
Estimated that all children will become infected with rotavirus at least once by the time they are five years old
Estimated that rotavirus causes around half of all gastroenteritis in children aged under five years
Rotavirus is a leading cause of gastroenteritis in infants and children throughout the world.
Gastroenteritis can have a number of possible causes, including norovirus infection or food poisoning. However, rotavirus is the leading cause in children.
It is a ubiquitous virus, virtually all children, rich or poor, living in the industrialised or developing world will become infected with rotavirus at least once by the time they are five years old. Individuals can have repeat infections, but the repeat infections tend to be less severe than the original infection2.
Rotavirus is so named because of its wheel like appearance under the electron microscope – the name rotavirus being derived from the Latin rota, meaning wheel.
There are a number of different strains of rotavirus. The vaccine protects against the most common circulating strains.

9. What is rotavirus? The incubation period is approximately 2 days
The incubation period is approximately 2 days
 Infectious period
Shedding of the virus in faeces may begin before the onset of major symptoms and may continue for several days after symptoms have resolved.
The incubation period for rotavirus is approximately 2 days.
Rotavirus is very infectious as the shedding of the virus in faeces may begin before the onset of major symptoms and may continue for several days after symptoms have resolved3,4.

10. Clinical presentation of rotavirus
Rotavirus gastroenteritis usually begins with the symptoms of
Diarrhoea
Vomiting
The child may also have
A fever (high temperature) of 38ºC or above
Abdominal pain
The symptoms of vomiting usually pass within one to two days. In most children, vomiting will not last longer than three days.
The symptoms of diarrhoea usually pass within five to seven days. Most children’s diarrhoea symptoms will not last longer than two weeks.
Rotaviruses affect one of the main functions of the intestines – the absorption of water from digested food into the body. This is why one of the common symptoms is diarrhoea.
More information on the clinical presentation is available at NHS Inform5

11. Complications of rotavirus
Gastroenteritis can cause dehydration:
This can be more serious than the rotavirus infection itself – and can require hospitalisation for intravenous rehydration
Virtually all children get rotavirus infection by age 5 yrs
1 in 5 of these will need medical attention
1 in 10 of these will need hospital admission
400 children are estimated to be admitted to hospital each year with rotavirus in Northern Ireland
The combination of the symptoms of vomiting, diarrhoea and fever can lead to dehydration, requiring admission to hospital for intravenous rehydration.
Almost all babies will get rotavirus within the first five years of life and about one in every five will need medical attention and about one in ten of these will be admitted to hospital with illnesses caused by the infection
Estimated that about 400 children under 5 in Northern Ireland are admitted to hospital each year with rotavirus
Although deaths from rotavirus in the UK are rare and are difficult to quantify accurately, there are likely to be approximately three to four a year in the UK6

12. Transmission of rotavirus
Rotavirus is highly infectious
As few as virus particles may cause disease
Transmission mainly via the faecal-oral route
Poor hand washing by young children leads to easy transmission, both by direct and indirect contact (contamination of surfaces etc.).
Small droplets of infected faeces can also be carried in the air, which children can breathe in.
Infants with rotavirus gastroenteritis can shed 100 billion infectious particles per gram of faeces7 but the infectious dose for humans may be as low as 10 infectious particles3. Thus, rotavirus is a very infectious pathogen.
Studies have also shown that in addition to being stable in most environmental conditions, rotavirus is also relatively resistant to most commonly used soaps and disinfectants. This allows the virus to persist in the environment and retain the potential to cause infection for significant periods of time8.

13. Why vaccinate infants against rotavirus?

14. Only a very small proportion of cases are confirmed by laboratory testing.  These cases are just the tip of the iceberg.
This graph shows that each year in Northern Ireland between about 400 and 700 people are laboratory confirmed with rotavirus.
Most cases of rotavirus do not require a stool sample to be submitted for testing, so these laboratory confirmed cases are just the tip of the iceberg.
A study of infectious intestinal disease9 has estimated that for every case of rotavirus that is laboratory confirmed another 43 (confidence interval range 30-62) occur in the community.

15. Why vaccinate against rotavirus? Epidemiology of rotavirus in Scotland
–who is most at risk?
This graph, from Scotland, shows the age of the laboratory confirmed cases of rotavirus in 2012, most (95%) of these occurred in children under 5 years of age, and about two thirds of these were children less than 2 years old.
The highest incidence was in children aged one year, with an incidence of 835 laboratory confirmed cases for every 100,000 children aged one year, but these are just the tip of the iceberg, as most cases won’t be laboratory confirmed.
As discussed previously people of any age can be infected with rotavirus but most infections occur in children between one month and four years of age. Children under one year and in particular if they are younger than six months are at increased risk of dehydration.
Infection in newborns is common but tends to be either mild or asymptomatic because of protection from circulating maternal antibodies10,11.
Data HPS

16. Northern Ireland 5-year average number of Rotavirus Cases, 2008-2012
These are Northern Ireland figures which show an almost identical pattern of illness here.
By vaccinating at 2 & 3 months it should be possible to prevent the vast majority of illness.

17. Why vaccinate against rotavirus
Why vaccinate against rotavirus? Recommendation from JCVI for rotavirus vaccine
The Joint Committee on Vaccination and Immunisation (JCVI) is the UK’s independent panel of immunisation experts.
JCVI recommends that rotavirus vaccination should be given to infants at two and three months of age i.e. two doses.
Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children
The Joint Committee on Vaccination and Immunisation (JCVI) is the UK’s independent panel of immunisation experts.
JCVI recommends that rotavirus vaccination should be given to infants at two and three months of age i.e. two doses.
Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children
Note: The JCVI (Joint Committee on Vaccination and Immunisation) is the advisory body for all immunisation policy. In 2009 JCVI considered the evidence on the burden of rotavirus infection and work on the cost effectiveness of rotavirus vaccination. The JCVI based on the available evidence advised that the licensed rotavirus vaccines would have a significant impact on reducing gastroenteritis in young children, and that the UK health departments should introduce the vaccines if they could be procured at a cost effective price12. This advice was reiterated in 2011 following consideration of a further cost effectiveness study.
It has now been confirmed that the programme will start in July this year.

18. Why vaccinate against rotavirus? Effectiveness of the vaccine
Very effective at protecting against the most common strains of rotavirus.
Very effective in protecting against severe rotavirus infection requiring hospitalisation.
Rotavirus vaccine has been shown to be very effective in protecting against the most common strains of rotavirus and severe rotavirus infection (infection resulting in hospitalisation). Rotavirus vaccine will not prevent diarrhoea or vomiting caused by other pathogens.
Data from clinical trials in Europe have shown that the vaccine has an efficacy of 91.8% (confidence intervals 84 to 96%) against rotavirus gastroenteritis requiring medical attention in the first year of life against the circulating strains of rotavirus14 (More details of the vaccine efficacy from the clinical trails are available in the Rotarix® SPC14 ))
Rotavirus vaccines, including the Rotarix® vaccine which will be used in Northern Ireland and the rest of the UK, are already used to routinely vaccinate children in the USA and many other countries. In the USA, studies have shown that rotavirus-related hospital admissions for young children have been cut by more than two thirds since rotavirus vaccination was introduced15.
A study has estimated that vaccinating a birth cohort of infants in England and Wales may prevent around 90,000 infections and 10,000 hospitalisations and around two deaths due to rotavirus in that cohort over the first five years of life16. It may also provide some additional protection to the wider population through herd immunity 17. In Northern Ireland this would equate to around 2,800 infections and just over 300 hospital admissions.

19. Vaccination against rotavirus The use of Rotarix®
Image courtesy of GSK

20. Vaccination against rotavirus – use of Rotarix®
From July 1st 2013 Rotarix® will be used for rotavirus immunisation programme
Generic name: Rotavirus vaccine, live
Marketed by GlaxoSmithKline
Licensed from 6 weeks to 24 weeks
Oral suspension in a prefilled oral applicator
Container dimensions 42x24x133mm
Rotarix® is a live attenuated vaccine (a weakened form of virus which cannot cause disease but which protects against rotavirus)
This is an oral vaccine and must not be injected
The packaging is similar in size to many currently used childhood vaccines
The vaccine was procured following a tendering exercise undertaken by the Department of Health of behalf of UK nations and ensured the vaccine was available at a cost-effective price.
Image courtesy of GSK

21. Vaccination against rotavirus – use of Rotarix® Rotarix® Composition
Active ingredient
Human rotavirus RIX4414 strain
Live attenuated
Not less than CCID50
Excipients
Sucrose
Di-sodium Adipate
Dulbecco’s Modified Eagle Medium
Sterile water
The live attenuated virus in Rotarix® is Human rotavirus RIX4414 strain which is produced on vero cells (monkey cell line). The virus was initially isolated from the stool of a 15 month old child and then attenuated by serial cell culture passage18.
Each dose contains not less than 106 Cell Culture Infectious Dose50
(the amount of virus required to produce an effect in 50% of inoculated tissue culture cells).
There are relatively few excipients. Disodium Adipate is an acidity regulator and Dulbecco’s Modified Eagle Medium is a cell culture medium.
Rotarix® does not contain any antibiotic traces, formaldehyde or preservatives such as thiomersal.
The plunger stopper and protective tip cap are both rubber butyl, which should not affect latex sensitive individuals.

22. Vaccination against rotavirus – use of Rotarix® Rotarix® presentation
Prefilled oral applicator
Oral suspension
Each dose contains 1.5ml of clear colourless liquid
Rotarix® is presented as a prefilled oral applicator containing 1.5ml of oral suspension.
The oral applicator is ready to use. No reconstitution or dilution is required.
The oral suspension should be a clear colourless liquid, free of visible particles. Before administration the vaccine should be visually inspected for particulate matter and/or abnormal physical appearance. In the event of either being observed the vaccine should be discarded.

23. Vaccination against rotavirus – use of Rotarix® Storage of Rotarix®
Rotarix® must be stored in accordance with manufacturer’s instructions
Cold chain must be maintained
- Store between +2°C and +8°C
- Store in original packaging
- Protect from light
Rotarix® must be stored in accordance with the manufacturer’s instructions. As with most vaccines Rotarix® should be stored between +2°C and +8°C.
The vaccine should be stored in the original packaging. This makes it easy to identify in the vaccine fridge, provides some protection against fluctuation of temperature and will protect from light.
Rotarix is an expensive vaccine and it is important to minimise wastage through inappropriate storage.

24. Vaccination against rotavirus – use of Rotarix® Rotarix® dosage and schedule
2 dose schedule
First dose of 1.5ml at 8 weeks (two months) of age
Second dose of 1.5ml at least four weeks after the first (i.e. 12 week appointment)
 - If interrupted resume course and no need to repeat first dose
 Both doses ideally by 15 weeks (i.e.14 weeks and 6 days) and no later than 24 weeks of age (i.e. 23 weeks and 6 days)
The first dose must be given before 15 weeks of age. If infant does not have first dose before 15 weeks then do not give Rotarix®
If infant spits out/regurgitates most of dose, one replacement dose may be given at same visit
Objective is to provide 2 doses of rotavirus vaccine to infants before 24 weeks (i.e. 23 weeks and 6 days) of age to protect against rotavirus infection.
The course is two doses with an interval of at least 4 weeks between doses 19
The routine programme will offer a first dose at the 8 week (2 month) visit when an infant receives their first primary immunisations. The second dose should be given at least four weeks after the first dose, ideally at the second visit for their primary immunisations due when they are 12 weeks (3 months) old.
Both doses of Rotarix® must be given by 24 weeks of age but ideally before 15 weeks of age.
The first dose of Rotarix® should not be given to infants aged after 15 weeks of age (i.e. 14 weeks and 6 days) (this is in line with recommendations from WHO), because of insufficient data on safety of a first dose of rotavirus vaccine in older infants. Both doses should be given by 24 weeks of age (i.e. 23 weeks and 6 days).
As they get older, some infants (about 120 per 100,000) develop intussusception. The background risk of intussusception increases to peak at around 5 months of age. Research from some countries suggests that Rotarix® may be associated with a very small increased risk of intussusception within seven days of vaccination, possibly two cases per 100,000 first doses given. The benefits of vaccination in preventing the consequences of rotavirus infection outweigh this small potential risk in young children. Because of the potential risk, and to reduce the likelihood of a temporal association with rotavirus vaccine, the first dose of vaccine should not be given after 15 weeks of age (i.e. 14 weeks and 6 days).
 Infants may receive their first dose of primary immunisations from 6 weeks of age in exceptional circumstances e.g. pre-travel but it is not routinely recommended to offer infants vaccine before 2 months of age. Rotarix® is licensed from 6 weeks of age.

25. Important Message
Unlike other childhood vaccines Rotarix® has an UPPER age limit beyond which it should not be given.
First dose must not be given after 14 weeks 6 days of age
Second dose must not be given after 23 weeks 6 days of age
Just to re-emphasise the point made on the previous slide as this is different from other routine childhood vaccines. Rotarix® has upper age limits that it should not be given beyond and it is very important that these are adhered to.

26. Vaccination against rotavirus – use of Rotarix® Administration of Rotarix®
Rotarix is different from the other infant vaccines, as it is a LIVE ORAL vaccine and must not be injected
Rotarix® can be administered at the same time as other childhood vaccines – it should be given before injected vaccines at same visit.
Rotarix® can be given at the same time as the other vaccines administered as part of the routine childhood immunisation programme, and so should ideally be given at the scheduled two month and three month vaccination visits 19.
Rotarix® can also be given at the same time as BCG or at any time before or after each other.
It is suggested to give Rotarix® to the infant at the beginning of their immunisation visit, before administration of intramuscular vaccines which may unsettle the infant.

27. Administration of Rotarix®
If the infants spits out or regurgitates most of the vaccine, a single replacement dose may be given at the same vaccination visit. There are no restrictions on infant’s feeding before or after vaccination. Breast-feeding does not reduce vaccine effectiveness so can be continued.
Remove the protective tip cap from the oral applicator
The child should be seated in a reclining position.
Administer orally i.e. into the child’s mouth, towards the inner cheek, the entire content of the oral applicator.
Do not inject the content, this is an oral vaccine
If the infants spits out or regurgitates most of the vaccine, a single replacement dose may be given at the same vaccination visit.
There are no restrictions on infant’s feeding before or after vaccination.
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastroenteritis afforded by Rotarix®. Therefore, breast-feeding may be continued during the vaccination schedule14.

28. Vaccination against rotavirus – use of Rotarix® Contraindications
Confirmed anaphylactic reaction to a previous rotavirus vaccine
Confirmed anaphylactic reaction to component of vaccine
Previous history intussusception
Over 24 weeks of age
Infants presenting for their first dose of Rotarix® over 15 weeks of age
Severe Combined Immunodeficiency (SCID) disorder
Congenital malformation of GI tract that could predispose to intussusception.
Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose insufficiency
There are very few infants who cannot receive rotavirus vaccine
There are very few infants who cannot receive the rotavirus vaccine - Specialist advice must be sought on the vaccine and circumstances under which it could be given. The risk to the individual of not being immunised must be taken into account.
Although the vaccine is a live attenuated virus, with the exception of severe combined immune-deficiency (SCID), the benefit from vaccination may exceed any risk in other forms of immunosuppression. Therefore, there are very few infants who cannot receive rotavirus vaccine. Where there is doubt, appropriate advice should be sought from an immunisation coordinator (via the Public Health Agency Duty Room) or Consultant Paediatrician rather than withholding vaccination.

29. Vaccination against rotavirus – use of Rotarix® Immunosuppression and HIV
Should not be administered to infants known to have severe combined immunodeficiency disorder (SCID)
Other immuno-suppressive disorders should be considered in relation to risks and benefits
Rotarix® vaccination is supported in HIV infected infants. Additionally infants of unknown HIV status, but born to HIV positive mothers should be offered vaccination
Rotavirus vaccination should not be administered to infants known to have Severe Combined Immunodeficiency Disorder (SCID).
There is a lack of safety and efficacy data on the administration of rotavirus to infants with other immuno-suppressive disorders. Administration of these cases should be considered in relation to the risks and benefits of vaccination. Given the high risk of exposure to natural rotavirus, however, the benefits of administration is likely to outweigh any theoretical risks and therefore should be actively considered, if necessary in collaboration with the clinician dealing with the child’s underlying condition.  
However, in a clinical study, 100 infants with HIV were administered Rotarix® lyophilised formulation or placebo. The safety profile was similar between Rotarix® and placebo recipients20. Therefore vaccination is supported in HIV infected infants. Additionally infants with unknown HIV status, but born to HIV positive mothers should be offered vaccination19.

30. Vaccination against rotavirus – use of Rotarix® Precautions
Acute severe febrile illness
Defer until recovered
Acute diarrhoea or vomiting
Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation
Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If infant is acutely unwell the immunisation may be deferred until they have recovered – this is to avoid confusing the differential diagnosis of acute illness by wrongly attributing signs or symptoms as adverse effects of the vaccine.
In infants with acute diarrhoea or vomiting the vaccine may be postponed until they have recovered – this is to make sure the vaccine is not regurgitated or passed through GI tract too quickly which could reduce the effectiveness of the vaccine

31. Vaccination against rotavirus – use of Rotarix® Precautions
Potential transmission of live attenuated vaccine virus from infant but:
Vaccination of the infant will offer protection to household contacts from wild-type rotavirus disease and outweigh any risk from transmission of vaccine virus to any immunocompromised close contacts
- Those in close contact with recently vaccinated infants should observe good personal hygiene
There is a potential for transmission of live attenuated virus in Rotarix® from the infant to severely immunocompromised contacts through faecal material for at least 14 days. 19, 21 However, vaccination of the infant will offer protection to household contacts from wild-type rotavirus disease and outweigh any risk from transmission of vaccine virus to any immunocompromised close contacts.
Additionally, those in close contact with recently immunised infants should observe good personal hygiene e.g. washing their hands after changing a child’s nappy

32. Rotarix® - Adverse reactions
In 3 placebo controlled trials, in which Rotarix was administered alone there was no significant difference in incidence or severity for: Diarrhoea; vomiting; loss of appetite; fever; irritability or cough/runny nose.
When given on its own and compared with placebo Rotarix® dose not seem to cause any of these symptoms more commonly than were reported with the placebo.

33. Vaccination against rotavirus – use of Rotarix® Adverse reactions
The most common adverse reactions observed after Rotarix® are
Diarrhoea
Irritability
Other reactions commonly reported are
Vomiting
Abdominal pain
Flatulence
Skin inflammation
Regurgitation of food
Fever
Loss of appetite
Fatigue
Other studies including those where Rotarix® was given with other routine childhood vaccines reported these reactions following vaccination. Some of them may have been due to Rotarix® but it is obviously difficult to differentiate from the other vaccines and the fact that many of these symptoms are common in infants anyway.
The full list of adverse reactions associated with Rotarix® is available in the marketing authorisation holder’s Summary of Product Characteristics’ 14.
Anaphylaxis is a very rare side effect of most vaccines and facilities for its recognition and management must be available.

34. Vaccination against rotavirus- Use of Rotarix® Intussusception
Intussusception is a naturally occurring condition of the intestines – around 120 cases per 100,000 children under 1 year.
Research from some countries suggests that Rotarix® may be associated with a very small increased risk of intussusception – possibly 2 cases per 100,000 first doses.
Even with this small potential risk, the benefits of vaccination in preventing the consequences of rotavirus infection outweigh any possible side effects
Intussusception is a naturally-occurring condition, with a background annual incidence of around 120 cases per 100,000 children aged under one year.
Intussusception occurs when a section of the bowel folds in on itself, like a telescope closing, typically at the junction of the ileum and the colon. The usual symptoms are episodes of pain, pallor and vomiting. It can lead to disruption of the blood supply to the bowel and can lead to perforation and gangrene.
Research from some countries suggests that Rotarix® may be associated with a very small increased risk of intussusception within seven days of vaccination, possibly 2 cases per 100,000 first doses given. Even with this small potential risk, the benefits of vaccination in preventing the consequences of rotavirus infection outweigh any potential side effects19.
Increasing the risk from 120 cases per 100,000 to 122 per 100,000 is obviously a very small difference and difficult to detect and may or may not be real.
Parents should be advised that if the infant develops severe vomiting and diarrhoea, pulls their knees up to their chests and has difficulty breathing they should contact their doctor immediately.
The risk of intussusception naturally rises with age during the first year and then falls again. It is for this reason that the first dose must be given before 15 weeks of age and the second dose before 24 weeks of age.

35. Vaccination against rotavirus Use of Rotarix® Reporting suspected adverse reactions
Yellow card scheme
- Voluntary reporting system for suspected adverse reaction to medicines/vaccines
- Success depends on early, complete and accurate reporting
- Report even if uncertain about whether vaccine caused condition -
See chapter 27a of Green book for details
As with all vaccine and other medicines registered healthcare practioners and patients are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the yellow card reporting scheme22.

36. Vaccination against rotavirus use of Rotarix®  Data management - Call and recall
Infants will be called for their immunisation against rotavirus at the same time as for their other immunisations at two and three months.
It is important to note that if an infant attends late for appointments the first dose must not be given at 15 weeks or later, or the second dose at 24 weeks or late.
All the other routine childhood vaccines can and should be given even if the infant is late.
Infants will be called for their rotavirus vaccine at the same time as their other infant immunisations at 2 and 3 months of age, using the Child Health System.
Vaccination will be recorded in the same way as the other infant immunisations.
Note:
If an infant attends late for their 2 and 3 months immunisations it is important to remember that both doses should be given by 24 weeks (i.e. 23 weeks and 6 days) of age but preferably before 15 weeks of age and infants who have not received a first dose by 15 weeks of age (ie 14 weeks and 6 days) should not be offered Rotarix®.
This does not apply to the other routine infant vaccinations which can be given if the infant presents late.

37. The registered healthcare practitioners’ key role
To provide clear and concise information to parents/guardians regarding vaccination against rotavirus
To safely administer this new oral vaccine to young infants according to the schedule.

38. Resources
Green Book
Incorporated into baby immunisation leaflet – will be available at:
Patient group direction
Q & A briefing – will be available at:
CMO letter  
Details on the rotavirus vaccine will be incorporated into the baby leaflet, no separate leaflet will be produced. There will be a Q&A briefing for health professionals and one for parents wanting more detailed information as well, these will be made available on the Public Health Agency Website.

39. Key Messages
Rotavirus is the most common cause of gastroenteritis in young children. Most children will experience at least one infection with rotavirus by the time they are five years old, some requiring hospitalisation for dehydration.
An oral vaccine against rotavirus is being introduced into the infant immunisation programme at the 2 and 3 month appointments
Rotavirus vaccination should significantly reduce rotavirus gastroenteritis in young children.
Rotavirus references
1 INTRODUCTION OF ROTAVIRUS VACCINE FOR BABIES AGED 2 AND 3 MONTHS
FROM 1 JULY 2013 INTO THE ROUTINE CHILDHOOD VACCINATION PROGRAMME CMO letter HSS(MD) 11/2013
2 Bernstein DI, Ward RL, Rotavirus. In Feigin RD, Cherry JD, eds. Textbook of Pediatric Infectious Diseases.
5th ed Vol 2. Philadelphia, Pa: Saunders; 2004; 4;
3 Bishop RF (1996) Natural history of human rotavirus infection. Arch Virol 12 (Suppl)
4 Raebel MA, Ou BS (1999) Rotavirus disease and its prevention in infants and children. Pharmacotherapy
19:
5 NHS Inform Rotavirus.
symptoms
6 Jit M, Pebody R, Chen M et al (2007) Estimating the number of deaths with rotavirus as a cause in
England and Wales. Hum Vaccin 3 (1) 23-6
7 Ansari SA, Springthorpe VS, Satter SA. (1991) Survival and vehicular spread of human rotaviruses:
Possible relation to seasonality of outbreaks. Rev Infect Dis 13:
8 Offit PA, Clark HF. Rotavirus. In Mandell GL, Bennett JE, Dolin R, eds. Mandelll, Douglas, and Bennett’s:
Principles and Practice of Infectious Diseases. 5th ed. New York: Churchill Livingstone; 2000:
9 The infectious intestinal disease 2 study.
reportdocuments/ _IID2_FINAL_REPORT.pdf
10 Grillner L, Broberger U, Chrystie I et al (1985) Rotavirus infections in newborns: an epidemiological and
clinical study. Scand J Infect Dis 17 (4)
11 Bishop RF (1994) Natural history of human rotavirus infection. In: Kapikian AZ (ed) Viral infections of the
gastroenteritis tract. New York: Marcel Dekker, p
12 JCVI statement on Rotavirus
13 Scottish Government news release for announcement of start of programme.
uk/News/Releases/2012/11/rotavirusvaccine
14 Rotarix®SPC, available on ema website.
EPAR_-_Product_Information/human/000639/WC pdf
15 Tate JE, Cortese MM, Payne DC, Curns AT, Yen C, Esposito DH, Cortes JE, Lopman BA, Gentsch JR,
Parachar UD (2011) Uptake, impact, and effectiveness of rotavirus vaccination in the United States:
review of the first 3 years of postlicencsure data. Pediatr Infect Dis J 30 (1 Suppl) S56-60
16 Jit M, Edmunds WJ (2007) Evaluating rotavirus vaccination in England and Wales. Part II. The potential
cost-effectiveness of vaccination. Vaccine 25:
17 Anderson EJ, Shippee DB, Weinrobe MH et al (2013) Indirect protection of adults from rotavirus by
pediatric rotavirus vaccination. Clin Infect Dis 56 (6)

40. Meningococcal C Vaccine.

41. Key Message
The changes will make the overall Meningococcal serogroup C conjugate immunisation programme more effective and offer greater protection by extending routine protection to adolescents and young adults.

42. Aims of resource
To raise awareness of current Meningococcal serogroup C epidemiology and the impact of the vaccination programme to date
To support healthcare professionals (HCPs) involved in discussing MenC vaccination with parents and young persons by offering evidence based information
To increase awareness of the changes among HCPs to ensure a smooth and effective transition to the new schedule   

43. Learning outcomes
Describe the aetiology and epidemiology of Meningococcal serogroup C disease
Understand the HCP’s role in implementing the changes to the MenC vaccination schedule
To be able to advise and reassure parents and young people of the changes in the MenC vaccination schedule by providing evidence based information
Be aware of useful resources

44. What is Meningococcal serogroup C disease?
Meningococcal disease occurs as a result of an invasive bacterial infection caused by Neisseria meningitidis
Transmission is by aerosol, droplets or direct contact with nasopharyngeal secretions and usually requires frequent or prolonged close contact
Incubation period 2 – 7 days
Meningococcal infection most commonly presents as either meningitis or septicaemia, or a combination of both
Meningococcal C is one of 12 serogroups of Neisseria meningitidis
In the UK serogroups B & Y are currently the most common, less common include C & W
Serogroups include A, B, C, E, H, I, K, L, W, X, Y, and Z
Since introduction of the routine meningococcal C conjugate vaccination programme, cases of invasive meningococcal disease in the UK from serogroup C have reduced dramatically, with serogroup B now accounting for the majority of cases.
Less commonly, individuals may present with pneumonia, myocarditis, endocarditis, pericarditis, arthritis, conjunctivitis, urethritis, pharyngitis and cervicitis.3

45. Clinical presentation of Meningococcal infection
Babies and toddlers
Children and young adults
Fever with poor peripheral perfusion
Poor feeding, refusing food or vomiting
Vomiting
Tense, bulging fontanelle and photophobia
Severe headache and photophobia
Fretful, unusual cry, moaning or rapid breathing
Confusion and irritability
Neck stiffness
Neck stiffness and muscle pain
Pale blotchy complexion & or non blanching rash
Pale blotchy complexion &/or non blanching rash
Drowsy & loss of consciousness
Symptoms can appear in any order, some may not appear at all.
Please note that some or all symptoms may appear, in any order, and this list is not exhaustive. Table contents based on Meningitis Trust
Onset of disease varies from fulminant with acute and overwhelming features, to insidious with mild prodromal symptoms.
Symptoms may be harder to identify in young infants particularly, the onset may be insidious and the signs be non-specific without classical features of meningitis.
Neck stiffness & muscle pain

46. The meningococcal rash
The rash starts as a cluster of pinprick blood spots under the skin, spreading to form bruises. It can appear anywhere on the body.
It can be distinguished from other rashes by the fact that it does not fade when pressed under the bottom of a glass (THE TUMBLER TEST).
A febrile illness and rash that does not fade under pressure is a sign of meningococcal septicaemia.
Absence of rash does not preclude the illness of meningitis
The ‘tumbler’ test picture courtesy of Meningitis Research Foundation

47. Meningococcal disease, potential complications
Overall mortality in the UK has reduced from 10% in 2005/6 to 5% in 2010/11
Mortality higher in cases with septicaemia than those with meningitis alone
Most common long term effects:
- Skin scarring Seizures
- Limb amputation Brain Damage
- Hearing loss
Mortality figures 2012 for England and Wales.4,5
In those who survive, approximately 25% may experience a reduced quality of life, with 10–20% developing permanent sequelae.6,7
The most common long-term effects are skin scars, limb amputation(s), hearing loss, seizures and brain damage.7,8

48. Background to MenC vaccination programme
In children and adolescents under the age of 18 years were offered MenC vaccine over a two-year period
January 2002 the campaign extended to include all adults under 25 years
Following the campaign the number of cases fell by over 90% in all age groups immunised
The objective of the routine immunisation programme is to protect those under 25 years of age and individuals outside this age range who may be at increased risk from meningococcal serogroup C disease
Following the MenC vaccine campaign, the number of laboratory-confirmed serogroup C cases fell by over 90% in all age groups immunised.9,10
Cases in other age groups fell by approximately two-thirds as a result of reduced carriage rates 11 and therefore reduced risk of exposure.12 This indirect protection has contributed to the number of cases falling to a very low levels.

49. Impact of MenC vaccination programme
The above figures shows that meningococcal disease caused by serogroup C has fallen by 95% since the introduction of the MenC vaccination programme in England and Wales. It shows this has occurred in those of all ages, as a result of both direct protection and indirect protection through herd immunity.
Number of laboratory confirmed serogroup C cases in England and Wales, Source: Public Health England, Infectious Disease Epidemiological Data

50. This graph shows that we have seen a similar decrease in Northern Ireland.

51. Reduction in capsular group C carriage following introduction of meningococcal serogroup C conjugate vaccines
Meningococci colonise the nasopharynx of humans and are frequently harmless commensals. Between 5 and 11% of adults and up to 25% of adolescents carry the bacteria without any signs or symptoms of the disease. In infants and young children, the carriage rate is low.13 Adolescence is the peak age for nasopharyngeal carriage of serogroup C meningococcus and rapid decline in rates of nasopharyngeal carriage were observed the year after the introduction of MenC vaccine.11
The MenC vaccination campaign significantly reduced nasopharyngeal carriage of serogroup C meningococcus as seen in above slide.14 Approximately 60% of the organisms found in this Maiden 2008 study were not B,C,W or Y. These typically were bacteria which did not have a capsule. A capsule is required for bacteria to cause disease so carriage of these other bacteria is harmless to humans.
This reduction in carriage provides indirect protection to unvaccinated and susceptible vaccinated members of the population through herd immunity.15
Slide courtesy of Prof Ray Borrow

52. Meningococcal disease cases by group and epidemiological year in England and Wales
This chart summarises laboratory confirmed cases of meningococcal disease in England and Wales since 1998/99 and only includes cases of invasive disease.
There has been a general decline in the numbers of invasive cases confirmed since 2000, with cases due to Neisseria meningitidis Group C becoming increasingly rare.
In England and Wales as a whole during the 2011/12 epidemiological year, 80.2% of invasive cases confirmed by the Manchester Reference Unit (MRU) were due to Neisseria meningitidis Group B and only 3.8% were due to Group C. This is in contrast to 1998/99 when 50.5% of invasive cases were due to Neisseria meningitidis Group B and 34.4% were due to Group C.
Source: Public Health England, Meningococcal Reference Unit, Invasive meningococcal infections laboratory reports, England and Wales, as at 14/09/2012

53. Again this shows a similar picture for Northern Ireland, with overall numbers decreasing and a particular decrease in Men C

54. Risk Factors
Age
Highest incidence in children under five years, peak incidence in those under one year of age. A second peak in incidence is noted in young people aged years of age
Season
Seasonal variation, peak levels in winter, declining to low levels by late summer
Social
Living in closed or semi – closed communities:
university halls of residence
military barracks
Smoking
Exposure to tobacco smoke increases the risk
Age, season, smoking, preceding influenza A infection and living in closed or semi-closed communities, such as university halls of residence or military barracks, have been identified as risk factors.12 The Ministry of Defence (MOD) offer MenC vaccine as part of their occupational health scheme.
The incidence of meningococcal disease is highest in children under five years of age, with a peak incidence in those under one year of age. There is a secondary peak in incidence in young people aged 15 to 19 years of age. In infants and young children, the carriage rate is low. 12
New entrants to university (freshers) who live in halls of residence have elevated risk of meningococcal disease compared to other college students. 6,17 Military recruits are at risk of acquiring meningococcal disease particularly in training camps and large scale mobilisations. 18
Fischer identified tobacco smoke as a risk factor in meningococcal disease. Tobacco smoke exposure independently increases the risk of developing meningococcal disease.19
The risk of meningococcal infection increases for students entering university compared with those of a similar age in the general population.16 The incidence of infection is:
5.1 cases per 100,000 in first year of university, and
1.4 cases per 100,000 in general population

55. What are the changes to the UK schedule for MenC vaccination
New starters at university/fresher students
Adolescents
Infants
The changes affect three parts of the schedule. One change is for babies, one is for adolescents, and one is for young people planning to attend a higher education establishment – the freshers catch-up programme.
JCVI Statement, January advises that in order to maintain low levels of disease and herd immunity there is evidence to support;
(i) one dose of serogroup C meningococcal vaccine offers protection to infants; and
(ii) Moving one dose of serogroup C meningococcal vaccine to adolescents will maintain herd protection for infants and younger children and extend protection for adolescents and young people.
The term fresher defined as new starters at a university setting under 25 years i.e. 24 years and 364 days
© Leah Millinship
© Leah Millinship
© Leah Millinship

56. Revised MenC vaccination schedule
Age
Dose
3 months
(12 weeks)
1 dose - MenC vaccine
NeisVac-C®, Menjugate Kit® only
Just after 1st birthday
1 dose Hib/MenC vaccine
Menitorix®
From years
1 dose MenC vaccine
Any MenC vaccine**
New starters at university/freshers *
Any MenC vaccine **
The infant part of the schedule
Since 2006, the MenC vaccination programme for babies has included three vaccinations - one at three months, one at four months and one given just after the 1st birthday. From 2013, this will change to just two men C vaccinations being given as an infant - one at three months of age, and a second one between 12 and 13 months.
Meningitec (Pfizer) should not be used to offer primary vaccination for infants as it is less immunogenic as a single dose in infancy than other vaccines. NeisVac-C (Baxter) or Menjugate Kit (Novartis) only should be used for the 3 month dose as they provide a good immune response after 1 dose in infants under 1 year of age, and strong immune responses when boosted with Hib/MenC (Menitorix) routinely offered just after 1st birthday. See “What vaccines are recommended” slide 22
At the start of the change over there may be a few infants aged 4 months or older who when they received their first dose were given Meningitec. These infants will still require a second dose. This should be given as either Meningitec or Menjugate Kit and NOT as Neisvac-C.
The adolescent part of the schedule
Schoolchildren will be given a MenC booster vaccination during adolescence. This will be given with the school leaving booster in school year 11 – ages years.
The new starters at university /freshers catch-up programme
Older adolescents, who are too old to have received a dose in year 11, are at a higher risk of contracting meningitis C when they first go to university. There will be a time limited catch up campaign to offer vaccine to freshers. This will start in summer The term fresher defined as new starters at university setting under 25 years i.e ( 24 and 364 days)
If unsure of previous immunisation status follow guidelines set out in Vaccination of individuals with uncertain or incomplete immunisation status available from
*Temporary catch up for new starters entering university setting under 25 years
** Any MenC vaccine can be given, Meningitec advised to help balance vaccine stocks

57. Why is there a change to the MenC vaccination schedule?
One dose MenC vaccine is now considered to offer sufficient direct protection to infants with the 12m booster
Individual protection in young children wanes 
A booster dose for adolescents will provide longer-term protection and maintain herd protection to help protect infants and younger children  
To protect freshers (temporary catch up for new starters at university setting under 25 years coomencing in 2014) because of an increased risk of disease and sub-optimal protection from vaccination under 10 years
In view of this the JCVI have advised that an adolescent dose of serogroup C meningococcal conjugate vaccine (MenC) be introduced and a dose of MenC vaccine in infants be removed.
Following a study that showed a single priming dose in infancy at three months of age would be sufficient to prime infants against meningococcal serogroup C disease, and provide protection for the first year of life.22 JCVI has recommended that the second priming dose at 4 months of age be removed from the routine schedule.
Recently published studies show that vaccination against meningococcal serogroup C disease in early childhood provides a short-term protective immune response Vaccination later in childhood provides higher levels of antibody that persist for longer.26
New starters to university (freshers) who live in halls of residence have elevated risk of meningococcal disease compared to other college students.16,17

58. When will the change to the schedule be implemented?
Infant
Child Health systems will stop inviting infants for MenC vaccination at 16 weeks from 1st June 2013
One dose in infancy has been shown to provide sufficient protection until booster at 12/13 months
The infant will still be called for other primary immunisations at 8, 12 and 16 weeks
Hib/MenC booster with MMR & PCV13 is still given just after 1st birthday.
Rotavirus vaccination starts July 1st 2013
As from 1st June 2013 infants will no longer be called for MenC vaccination at age 16 weeks. This is earlier than other changes to the schedule to help manage vaccine stock levels to support other changes to the programme.
At 8 Weeks infant will be called for DTaP/IPV/Hib and PCV13
At 12 weeks infant will be called for DTaP/IPV/Hib and Men C
At 16 weeks infant will be called for DTaP/IPV/Hib and PCV13
From July 1st rotavirus vaccine will be introduced, two doses at 8 and 12 weeks alongside the other routine vaccines.
Further information on current UK routine schedule for childhood immunisation is available from the Green Book, chapter 11, The UK Immunisation Programme at 1

59. When will the change to the schedule be implemented?
Adolescent
Begin in academic year starting September 2013
An adolescent booster dose of MenC vaccine to be given at same time as the Td/IPV teenage booster vaccine
HPV and MMR vaccines can be given at same time
Delivered through school based delivery model
Vaccination later in childhood provides higher levels of antibody that persist for longer.26
Should be delivered alongside Td/IPV from 14/15 years (Academic Year 11). Note: MenC can be given at the same time as other vaccines such as HPV and MMR. Although we wouldn’t routinely offer HPV to girls at this stage they can be given at the same time if necessary. Those children who have not ha 2 doses of MMR vaccine by the time they are offered their teenage booster are offered MMR at the same time, this can still be done when Men C is also being offered.
The Men C should be offered whenever the “school leaving booster” would normally have been offered, there is not need to change the timing, for example if it is to be offered around January-March time that is ok and there is no need to re-schedule.

60. When will the change be implemented?
New starters at university/freshers,
From summer 2014
A time limited catch-up programme offering vaccine to freshers entering university
Defined as new starters at university under 25 years i.e 24 years and 364 days
Ideally provided by own GP at least 2 weeks before starting university
Information provided with offer of university place
Those that have received a Men C vaccine over the age of 10 years will not require the booster dose
This will be introduce next year – summer 2014
Information for students is likely to be provided with the offer of university place via UCAS and students will be advised to attend their GP prior to starting university. The increased risk has been found to be more pronounced in the first days or weeks27 when students first start to live and socialise together in halls of residence/campus.16,17
Seroconversion can take up to two weeks so vaccination should ideally take place at least two weeks prior to the student leaving for university
The freshers catch-up programme is of limited duration to offer the vaccine to those young people entering university for the first time who will not have been vaccinated under the revised schedule at age years and is likely to run for several years.
Evidence that the risk of meningococcal infection  increases for students entering higher education compared with those of a similar age in the general population:
5.1 cases per 100,000 in first year of higher education
1.4 cases per 100,000 in general population16
The increased risk is in the first few days, weeks or months of entering higher education It has been suggested that increased exposure to meningococcal bacteria occurring in the first year of higher education leads to asymptomatic carriage that boosts immunity to provide protection over subsequent years.16,30
If the young person had a dose of MenC vaccine after the age of ten years, they don’t need another dose if going to university.26

61. Which vaccines are recommended?
Age
Primary/Booster
Product
3 months
(12 weeks)
Primary
MenC
NeisVac-C® or Menjugate Kit®only
12-13 months
Booster
Hib/MenC Vaccine Menitorix®
From years
MenC Vaccine
All can be given
New starters at university /freshers
Meningitec (Pfizer) should not be used to offer primary vaccination for infants as it is less immunogenic as a single dose in infancy than the other vaccines. NeisVac-C (Baxter) or Menjugate Kit (Novartis) only should be used for the 3 month dose as they provide a good immune response after 1 dose in infants under 1 year of age, and strong immune responses when boosted with Hib/MenC (Menitorix) routinely offered at months
The MenC conjugate vaccines are made from capsular polysaccharide that has been extracted from cultures of serogroup C Neisseria meningitidis. In the UK, MenC vaccines have been used that have been conjugated with either CRM197 (a non-toxic variant of diphtheria toxin) or tetanus toxoid. The conjugation increases the immunogenicity, especially in young children in whom the plain polysaccharide vaccines are less immunogenic. The Monovalent MenC vaccine confers no protection against other serogroups of meningococcal disease, such as A, B, W, or Y.
Supply issues may dictate use of Meningitec® for teenagers and freshers

62. USE THE CORRECT VACCINE
Vaccine products
Primary under 1 year
Primary under 1 year
X Primary under 1 year
© Docsimon
©Baxter
The MenC conjugate vaccine is available either as a lyophilised powder for reconstitution with a diluent or as a suspension in a syringe. After reconstitution of the lyophilised suspension, the vaccine must be used within one hour.
Given by intramuscular injection
May only be administered:
Against a prescription written manually or electronically by a registered medical practitioner or other authorised prescriber
Against a Patient Specific Direction (PSD)
Against a Patient Group Direction (PGD)
The vaccines do not contain thiomersal. They are inactivated, do not contain live organisms and cannot cause the diseases against which they protect.
Further information on the vaccine products is available from the Summary of Product Characteristics (SPC)
Meningitis and Menjugate are available from at:
NeisVac-C SPC is available from the Baxter website at:
© Science photo library
USE THE CORRECT VACCINE
Meningitec® is less immunogenic, as a single dose in infancy than other vaccines

63. Different schedules for MenC vaccines
Summary of Product Characteristics (SPC) for MenC conjugate vaccines state that two doses should be given two months apart in those under 1 year of age This is superseded by the Green Book recommendation to give a single dose of NeisVac-C® or Menjugate Kit® MenC vaccine in infancy Consideration should be given as to whether a quadrivalent meningococcal vaccine should be used if protection is required for travel
The recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) for a particular vaccine. When this occurs, the recommendations in the Green Book 1 are based on current expert advice received from the JCVI and should be followed.
The Green Book 1 states that evidence from a UK study shows that immunogenicity is adequate following a primary course of either NeisVac- C or Menjugate Kit as a single dose in infants.22 and the UK schedule for childhood vaccination has been amended to reflect this evidence.
The Green Book 1 states MenACWY conjugate vaccine (Menveo) should replace the monovalent MenC vaccine if the infant requires protection for travel at the same time as the routine MenC

64. Contraindications and precautions
Confirmed anaphylactic reaction to a previous dose of the vaccine
Confirmed anaphylactic reaction to any constituent of the vaccine, including meningococcal polysaccharide, diphtheria toxoid or the CRM197 carrier protein or tetanus toxoid
Precautions
Acute febrile illness (defer until recovered)
Unstable/evolving neurological conditions
There are very few individuals who cannot receive meningococcal vaccines. When there is doubt, appropriate advice should be sought from a consultant paediatrician, immunisation co-ordinator or consultant in communicable disease control, rather than withhold immunisation.
Meningitec and Menjugate Kit vaccines are conjugated to Corynebacterium diphtheriae CRM197 protein. NeisVac-C is conjugated to tetanus toxoid protein.
More detailed vaccine information and a full list of vaccine contents are contained in the Summary of Product Characteristics (SPC)
Meningitec and Menjugate Kit are available from at:
NeisVac-C SPC is available from the Baxter website at:
Minor illnesses without fever or systemic upset are not valid reasons to postpone immunisation. If an individual is acutely unwell, immunisation may be postponed until they have recovered fully. This is to avoid confusing the differential diagnosis of any acute illness by wrongly attributing any signs or symptoms to the adverse effects of the vaccine
Meningococcal vaccines may be given to pregnant women when clinically indicated. There is no evidence of risk from vaccinating pregnant women or those who are breast-feeding with inactivated virus or bacterial vaccines or toxoids. 7 In cases where meningococcal immunisation has been inadvertently given in pregnancy, there has been no evidence of fetal problems.

65. Adverse events
Pain, tenderness, swelling or redness at the injection site and mild fever
Infants and toddlers: crying, irritability, drowsiness, impaired sleep, reduced eating, diarrhoea and vomiting
Older children and adults: headaches, myalgia and drowsiness
Neurological reactions such as dizziness, febrile/afebrile seizures, faints, numbness and hypotonia are very rare
Anaphylaxis is a very rare side effect of most vaccines and facilities for its recognition and management must be available.
Further information on adverse events are contained in the Summary of Product Characteristics (SPC)
Meningitec and Menjugate are available from at:
Neisvac SPC is available from the Baxter website at:

66. Reporting Adverse Events
Yellow card scheme
Voluntary reporting system for suspected adverse reaction to medicines/vaccines
Serious adverse events in adults or all suspected adverse reactions in children that may be attributable to the vaccine should be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) using the yellow card system
Chapter 8 of Green Book
for details
As with all vaccines and other medicines healthcare professionals and patients are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the yellow card reporting scheme
© MHRA

67. Supplies Meningitis C conjugate:
Menjugate® – manufactured by Novartis Vaccines
NeisVac-C® – manufactured by Baxter Healthcare
Meningitec® – manufactured by Pfizer  
Supplies should be obtained in line with routine ordering for childhood vaccines
Vaccines should be ordered from the local Trust pharmacy as for other childhood vaccines – it will be important to specify which age group they are for.

68. Monitoring uptake
Vaccination against MenC should be recorded in the GP, patient and child health computer records as routine
Immunisation uptake data will be collected using the Child Health Information System for the infant and teenage doses
For the infant group monitoring uptake would be based on the same reporting measures for vaccines given as part of the routine childhood schedule.
For adolescent dose uptake will be monitored as teenage booster Td/IPV vaccination.

69. Resources
Green Book
Patient group direction (PGD)
Chief Medical Officer (CMO) Letter
Leaflets/posters/factsheets/ – will be available at:
Details of the changes will be built into the various relevant leaflets – babies, teenage etc. The only separate leaflet is likely to be one for Freshers when that programme is introduced.

70. Key Message
The changes will make the overall Meningococcal serogroup C conjugate immunisation programme more effective and offer greater protection by extending routine protection to adolescents and young adults
Bibliography for Men C
1. Department of Health (2005) Immunisation against infectious disease. The Green Book . [Online]. Available at: [Accessed 15th Mar 2013]
2. CMO letter
3. Rosenstein NE et al. Meningococcal disease. N Engl J Med 2001; 344:
4. Goldacre MJ, Roberts SE, Yeates D. Case fatality rates for meningococcal disease in an English population, : database study. BMJ 2003; 327:
5. Ladhani SN et al. Invasive meningococcal disease in England and Wales: implications for the introduction of new vaccines. Vaccine 2012; 30:
6. Erickson L, De Wals P. Complications and sequelae of meningococcal disease in Quebec, Canada, Clin Infect Dis 1998; 26:
7. Granoff DM, Harrison LH, Borrow R. Section 2: Licensed vaccines meningococcal vaccines. In: S Plotkin, W Orenstein, P Offit eds. Vaccines. 5th ed. London: Elsevier 2008; pp:
8. Steven N, Wood M. The clinical spectrum of meningococcal disease. In: K Cartwright K ed. Meningococcal disease. Chichester: John Wiley & Sons; pp
9. Miller E, Salisbury D, Ramsay M. Planning, registration, and implementation of an immunisation campaign against meningococcal serogroup C disease in the UK: a success story. Vaccine 2001; 20(Suppl 1):S58-S67
10. Trotter CL et al. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet 2004; 364:
11. Maiden MC, Stuart JM. Carriage of serogroup C meningococci one year after meningococcal C conjugate polysaccharide vaccination. Lancet 2002; 359:
12. Trotter CL, Gay NJ. Analysis of longitudinal bacterial carriage studies accounting for sensitivity of swabbing: an application to Neisseria meningitidis. Epidemiol Infect 2003; 130: Available at: [Accessed 15th Mar 2013]
13. Cartwright K. The clinical spectrum of meningococcal disease. In: K Cartwright ed. Meningococcal disease. Chichester: John Wiley & Sons; pp
14. Maiden MC et al. Impact of meningococcal serogroup C conjugate vaccines on carriage and herd immunity. J Infect Dis 2008; 197:
15. Ramsay ME et al. Herd immunity from meningococcal serogroup C conjugate vaccination in England: database analysis. BMJ 2003; 326:
16. Bruce MG et al. Risk factors for meningococcal disease in college students. JAMA 2001;286:
17. Harrison LH et al. Risk of meningococcal infection in college students. JAMA 1999;81: Available at: [Accessed 15th Mar 2013]
18. Brundage JF, Zollinger WD. Evolution of meningococcal disease epidemiology in the US Army. In: NA Vedros ed. Evolution of meningococcal disease. Vol. 1. Boca Raton: CRC Press; pp
19. Fischer M et al. Tobacco smoke as a risk factor in meningococcal disease Pediatr Infect Dis J 1997; 16:
20. Joint Committee of Vaccination and Immunisation. Statement on the use of meningococcal C vaccines in the routine childhood immunisation programme. 29 January [Online] Available at: [Accessed 15th Mar 2013]
21. Health Protection Agency. Vaccination of individuals with uncertain or incomplete immunisation status. [Online] Available at: [Accessed 15th Mar 2013]
22. Findlow H et al. Immunogenicity of a single dose of meningococcal group C conjugate vaccine given at 3 months of age to healthy infants in the United Kingdom. Pediatr Infect Dis J 2012; 31:
23. Borrow R et al. Kinetics of antibody persistence following administration of a combination meningococcal serogroup C and haemophilus influenzae type b conjugate vaccine in healthy infants in the United Kingdom primed with a monovalent meningococcal serogroup C vaccine. Clin Vaccine Immunol 2010; 17:
24. Kitchin N et al. Antibody persistence in UK pre-school children following primary series with an acellular pertussis-containing pentavalent vaccine given concomitantly with meningococcal group C conjugate vaccine, and response to a booster dose of an acellular pertussis-containing quadrivalent vaccine. Vaccine 2009; 27:
25. Perrett KP et al. Antibody persistence after serogroup C meningococcal conjugate immunisation of United Kingdom primary–school children in and response to a booster: a phase 4 clinical trial. Clin Infect Dis 2010; 50:
26. Snape MD et al. Seroprotection against serogroup C meningococcal disease in adolescents in the United Kingdom: observational study. BMJ 2008; 336: Available at: [Accessed 15th Mar 2013]
27. Neal KR et al. Changing carriage rate of Neisseria meningitidis among university students during the first week of term: cross sectional study. BMJ 2000; 20:846-9.
28. Ala’Aldeen DA et al (2011) Carriage of meningococci by university students, United Kingdom. Emerg Infect Dis 2011; 17:
29. Bidmos FA et al. Persistence,replacement and rapid clonal expansion of meningococcal carriage isolates in a 2008 university student cohort. J Clin Microbiol 2010; 49:506.
30. Butler KM. Meningococcal meningitis prevention programs for college students: A review of the literature. Worldviews Evid Based Nurs 2006;3: