1. Prevention of Influenza in Infants by Immunization of Their Contacts in the Household
Emmanuel Walter MD, MPH
30 March 2009

2. COI - Disclaimers √ Sponsor Grant support Speaker Advisory Board GSK
Medimmune
Merck
Novartis
sanofi pasteur
Wyeth

3. Background
Elevated influenza related morbidity and mortality among children < 6 months of age
No currently approved influenza vaccine for this age group
ACIP recommendation for “prevention efforts that focus on vaccinating household contacts and out-of-home caregivers to reduce the risk for influenza in these infants”

4. Background
Despite recommendation for use of influenza vaccine during pregnancy, in only 13.4% (8.5, 20.5) of non-high risk pregnant women reported receipt of a flu vaccine
During , influenza vaccine coverage for household contacts of persons at high risk including but not limited to children < 5 years of age varied by age of the household contact
Aged 5-17 years % (21.5, 31.1)
Aged years % (15.0, 19.4)
National Health Interview Survey

5. Objectives
To develop and assess a hospital-based program for administering influenza vaccine to newborn household contacts during the immediate postpartum period (October February 2008)
Assess influenza vaccine coverage among household contacts of newborns delivered at a hospital with postpartum influenza immunization program
Simultaneously assess influenza vaccine coverage among household contacts of newborns delivered at a hospital without a postpartum influenza immunization program
ClinicalTrials.gov:NCT

6. Setting Immunization Program No Immunization Program
Duke University Hospital
Durham Regional Hospital
Durham County, NC

7. Vaccination Program
Standing order to administer influenza vaccine to postpartum women by nursing staff
Educational packets distributed to new mothers by nursing staff
Letter introducing the study and immunization program
Coupons for a free influenza vaccine for household contacts
Vaccine information statement for TIV
Promotional Materials

8. Promotional Materials
Buttons for Staff
Posters

9. Vaccination Program
Standing order for influenza vaccine to be administered to newborn household contacts by part-time study nurse
Vaccine clinic located adjacent to the postpartum ward
Educational sessions with medical and nursing staff
Mailed vaccine reminders within 4 weeks after delivery

10. Vaccine Clinic for Household Contacts

11. Piiitch Influenza Vaccine Clinic

12. Outcome
Primary Outcome - Influenza vaccination coverage for household contacts of newborns delivered at both hospitals
Hospital with Immunization Program – Anonymous survey distributed by hospital staff during the postpartum period
Both Hospitals – Face-to-face postpartum interview and follow-up telephone interview at 6 to 8 weeks postpartum

13. Self-administered Survey
Distributed to post-partum women (as part of educational packet) by nursing staff
Survey questions – baby’s birth month, maternal vaccination status, contraindications to vaccination, and household contact information (age, relationship, vaccination status)
2-part NCR form
Top – Identified (vaccination administration record)
Bottom – Anonymous and linked to vaccine coupons for household contacts (collected for study staff)

14. Interviews Face-to-face post-partum interview
Random selection on day of discharge (M – F)
Informed consent
Exclusion criteria - fetal demise or stillbirth, parental rights relinquished, language barrier
Demographics, contact information, prenatal care and delivery history, vaccination status, maternal high-risk conditions, household contact information (age, relationship, vaccination status)
Follow-up telephone interview (6 to 8 weeks)
Vaccination status for household contacts

15. Hospital and Study Populations
Hospital with Program
Hospital without Program
Newborns (n)
904
1332
New Mothers (n)
890
1286
Surveys Distributed
733 (82.4%)
N/A
Surveys Returned
493 (67.2%)
Approached for interview
364 (40.9%)
524 (40.7%)
Interviewed
238 (65.4%)
306 (58.4%)
Follow-up interview
194 (81.5%)
237 (77.4%)

16. Characteristics of Women Surveyed
Hospital with Program N=493
Race/Ethnicity (%) Hispanic
2.4
Black
30.9
White
58.7
Asian
5.1
Other
2.9
Birth Month (%) Oct
18.7
Nov
21.1
Dec
Jan
20.3
Feb
18.9

17. Survey - HC Immunization Rates (IR)

18. Survey – Mothers IR by Month

19. Survey – Fathers IR by Month

20. Survey – Siblings IR by Month

21. Survey – HC IR by Mother’s Vaccination Status

22. Characteristics of Women Interviewed
Hospital with Program N=238
Hospital without Program N=306
P- value
Age, years (Median)
29.0
26.0
<.001
Ethnicity (%) Hispanic
3.4
43.5
Race (%) Black
30.9
35.7
White
59.7
37.3
Asian
4.7
5.1
Other
22.0
Education (%) < 12 Grade
3.8
32.4
HS Grad / GED
15.5
26.5
Some College
22.7
17.6
College Grad
30.3
9.8
> 1 yr Post Grad
27.7
13.7

23. Characteristics of Women Interviewed
Hospital with Program N=238
Hospital without Program N=306
P- value
Marital Status Married
70.2
45.4
<.001
Insurance Medicaid
23.5
32.4
Medicare
0.0
0.7
Private / Mgd Care
75.2
28.4
None
1.3
38.6
Care Site Private Office
89.4
19.2
Health Dept
3.4
5.1
Community HC
7.2
43.4
Hospital Clinic
32.0

24. Characteristics of Newborns and Households
Hospital with Program N=238
Hospital without Program N=306
P- value
Gestation, wks (Median)
39.3
39.1
0.387
Birth weight, kg (Median)
3.3
3.2
<.015
Household Contacts
Fathers
206
242
Siblings
172
295
Other Relatives 98
288
Non-relatives 4 49

25. Interview - HC Immunization Rates (IR)

26. Interview - HC IR if Not Vaccinated Before Delivery

27. Hospital Comparison
* P <.05

28. Predictors of Maternal Immunization
Odds Ratio for Immunization
p-value
Age
1.05 (1.02, 1.09) per 1 year older
0.002
Ethnicity (Hispanic)
1.53 (1.00, 2.34) vs, non-Hispanic
0.050
Race (Black)
0.64 (0.43, 0.94) vs. all other races
0.023
Insurance
0.001
(Private)
1.94 (1.29, 2.93) vs. Medicaid
(None)
2.32 (1.39, 3.88) vs. Medicaid
Education
0.009
(HS grad / GED, some college)
0.66 (0.41, 1.08) vs. grade 12 or less
0.099
(College)
0.96 (0.54, 1.72) vs. grade 12 or less
0.890
(Post grad)
1.61 (0.88, 2.96) vs. grade 12 or less
0.130
Hospital (Program)
1.30 (0.91, 1.87) vs. no program
0.149

29. Predictors of Maternal Immunization: Multivariable Model
Odds Ratio for Immunization
p-value
New Mothers
Age
1.04 (1.01, 1.08) per 1 year older
0.018
Insurance (None)
2.52 (1.52, 4.20) vs. private or Medicaid
0.004
Education (Post grad)
1.89 (1.11, 3.24) vs. all other education levels
0.020
Hospital (Program)
1.53 (1.02, 2.30) vs. no program
0.041

30. Conclusions
A hospital based influenza vaccination program is a feasible way to improve influenza vaccine coverage of household contacts of newborns.
Reported immunization rates of new mothers and fathers increased by nearly 30%
Improvement was notable but less remarkable among other household contacts
The largest increases in immunization rates were noted in the first few months of the program
In addition to hospital site, advanced maternal age and education, and health insurance status were predictors of maternal immunization status.

31. Acknowledgements Investigators Study staff
Duke – Rowena Dolor, MD, MHS, Geeta Swamy MD, and Anne Hellkamp, MS
CDC – Norma Allred PhD, MSN
Study staff
Duke – Luis Ballon, Kathlene Chmielewski and
Beth Patterson RN, BSN
Durham Regional Hospital (DRH) – Diane Wingo RN
Postpartum nursing staff at DRH and Duke
Parents and household contacts of newborns
CDC:5U01 IP