Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-1 MENACTRA ™ Meningococcal.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-1 MENACTRA ™ Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Vaccines and Related Biological Products Advisory Committee September 22, 2004

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-2 Menactra - Agenda  IntroductionLuc Kuykens, MD, MPH VP Regulatory Affairs  EpidemiologyGreg Gilmet, MD, MPH Director Scientific & Medical Affairs  ImmunogenicityMichael Decker, MD, MPH VP Scientific & Medical Affairs  SafetyGary Chikami, MD Senior Director Regulatory Affairs  ConclusionsLuc Kuykens, MD, MPH VP Regulatory Affairs

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-3 Public Health Need for Improved Meningococcal Vaccine  Persistence of bactericidal antibodies  Ability to prime and boost  Absence of hyporesponsiveness seen with current polysaccharide vaccines  Reduction in carriage  Herd immunity

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-4 Vaccine Formulation MenactraMenomune ® (single dose) 4 µg each A,C,Y,W-135 PS50 μg each A,C,Y,W-135 PS 48 μg of diphtheria toxoid No adjuvantNo adjuvant No preservativeNo preservative Liquid formulationLyophilized formulation Administered IMAdministered SC

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-5 Menactra - Content  Polysaccharides manufactured under the existing license for Menomune  Diphtheria toxoid manufactured under existing license for Tripedia ®

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-6 Menactra - Clinical Experience Persons Receiving Population Clinical TrialsMenactra Persons Receiving Population Clinical Trials Menactra Adults33,911 Adolescents33,731 Children32,649 TOTAL910,291

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-7 Menactra - Clinical Experience Persons Receiving Population Clinical TrialsMenactra Persons Receiving Population Clinical Trials Menactra Adults33,911 Adolescents33,731 TOTAL67,642 Children32,649

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-8 Menactra Clinical Development Program  Active comparison to standard of care  Demonstration of non-inferiority for both immunogenicity and safety  Concomitant administration with Td and Typhim Vi

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-9 Menactra Key Findings  Menactra met every pre-specified criteria for non-inferiority – Immunogenicity – Safety  Menactra demonstrated characteristics of conjugate vaccine – Persistence – Prime and boost – Overcomes hyporesponsiveness

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-11 Presentation Outline  Clinical Challenge of Meningococcal Disease  Current U.S. Epidemiology  Current UK and European Epidemiology  Benefits of Conjugate Vaccines  UK Experience with C Conjugate Meningococcal Vaccines  Epidemiology Summary

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-12 The Challenge of Invasive Meningococcal Disease  Most common cause of bacterial meningitis  Unique ability to cause outbreaks and epidemics  Serogroups shift over time and geography  Strikes healthy individuals  High mortality rate (10-15%)  60% symptomatic < 24 hrs prior to hospitalization  Difficult to diagnose, high emotional impact

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-14 Changing Meningococcal Serogroup Distribution in the U.S.* *ABCs data 1997 - 2003 1990 - 1992 C = 24% W135 + Other = 14% B = 34% Y = 28% Y = 9% C = 40% B = 43% W135 + Other = 8%

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-15 Reported Cases of Meningococcal Disease, U.S., 1967-2002 Number of Reported Cases Year 0 500 1000 1500 2000 2500 3000 3500 4000 1967 19711975197919831987199119951999 1,323 3,525 CDC MMWR Oct. 1997, Apr 2004.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-16 Age- and Gender-Specific Rates of Meningococcal Disease in the U.S. Rosenstein NE, et al. J Infect Dis. 1999;180:1894-901. Age (years) Incidence per 100,000 Population Male 0 1 2 3 4 5 6 5-910-1415-1920-2425-2930-3435-3940-4445-4950-5455-5960-6465-6970-7475-7980-84 ≥ 85 0-4 Female

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-17 Most Cases in U.S. Adolescents and Young Adults Are Potentially Vaccine-Preventable* *Serogroup distribution by age group, United States, 1994–1998; potentially vaccine preventable was calculated assuming 100% efficacy using an A/C/Y/W-135 quadrivalent vaccine. CDC. MMWR Morb Mortal Wkly Rep. 2000;49(RR-7):13. 48%48%65% 71%70%79% 87% Potentially Vaccine-Preventable 0 25 50 75 100 125 150 175 200 225 250 0-22-56-1112-1718-2324-54>55 Age Group Number of Cases B C Y W-135

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-18 Distribution of Meningococcal Fatalities by Age Group, U.S. 1997 – 2001 CDC. Natl. Vital Stats. Rep. Number of Deaths 139 146 135 266 90 93 102 48 56 57 48 0 50 100 150 200 250 300 <11-45-1415-2425-3435-4445-5455-6465-7475-84>85

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-19 Harrison LH, et al. Invasive Meningococcal Disease in Adolescents and Young Adults. JAMA. 2001;286:694-699. Meningococcal Disease in Adolescents and Young Adults: Increased Lethality; More Vaccine-Preventable EventsEvents Variable<15 yrs15-24 yrsP-Value Death4.6%22.5%.001 Vaccine- Preventable Disease*68.1%82.8%.04 *Defined as serogroups A, C, Y, W-135.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-20 Impact of Polysaccharide Immunization on Hospitalizations (U.S. Army 1964-1998) *Bars indicate hospitalization frequencies; line indicates rates. DeFraites RF. MSMR. 2000;6:2. Year Number of Hospitalizations Monovalent (Group C) Bivalent (A,C) Quadrivalent (A,C,Y,W-135) 0 50 100 150 200 250 300 350 400 450 500 196419681972197619801984198819921996 0 5 10 15 20 25 30 35 Hospitalization Rates (per 100,000 person - years)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-21 Rates of Meningococcal Disease in College Students, U.S., 9/1/98 - 6/30/99 Rates/ Groups# CasesPopulation100,000 All 18-23 year olds30422,070,5351.4 College Students9014,897,2680.6 Undergraduates8712,771,2280.7 Freshmen Students402,285,0011.9 Dormitory Residents452,085,6182.3 Freshmen Living in Dormitories27591,5875.1 Centers for Disease Control and Prevention. Prevention and control of meningococcal disease and Meningococcal disease and college students: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 2000;49(RR-7);1-20. Updated in: Bruce MG et al [CDC]. Risk Factors for Meningococcal Disease in College Students. JAMA. 2001;286:688-693.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-23 Europe European and U.S. Meningococcal Serogroup Distribution B = 63% C = 32% Y = 1% U.S. 1998-20021997-2003 C = 24% W135 + Other = 14% B = 34% Y = 28% W-135 + Other = 4% European Union Invasive Bacterial Infections Surveillance Network. 2002.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-24 Carriage Rates of N. meningitidis College Freshmen, Nottingham University, UK, 1997 Neal KR, et al. BMJ. 2000;320:846-49. 0 5 10 15 20 25 30 35 Day 1 Day 2 Day 3 Day 4 Month 1 Month 2 Time Carriage Rate (%)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-26 PropertyPolysaccharide Conjugate T-cell-dependent immune responseNoYes Immune memoryNoYes Persistence of protectionNoYes Booster effectNoYes Reduction of carriageNoYes Herd immunityNoYes Lack of hyporesponsivenessNoYes Conjugate vs. Polysaccharide Vaccines Granoff, DM et al. In: Plotkin SA, ed. Vaccines. 4th ed. Philadelphia: W.B. Saunders Co;2004.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-27 PropertyPolysaccharide Conjugate T-cell-dependent immune responseNoYes Immune memoryNoYes Persistence of protectionNoYes Booster effectNoYes Reduction of carriageNoYes Herd immunityNoYes Lack of hyporesponsivenessNoYes Conjugate vs. Polysaccharide Vaccines Granoff, DM et al. In: Plotkin SA, ed. Vaccines. 4th ed. Philadelphia: W.B. Saunders Co;2004.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-29 Meningococcal Serogroup C-conjugate Vaccine  Licensed in the United Kingdom in 1999–2000  Initially introduced in 15- to 17-year-olds, as they displayed highest mortality rates  Younger age groups sequentially added  C-conjugate subsequently introduced in Spain, Ireland, Belgium, Netherlands, Canada, and Australia

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-30 Laboratory Confirmed Cases of Serogroup C Meningococcal Disease, England and Wales Cumulative Cases Ages 15 to 17 Week Number (total from mid-year) Number of Cases Immunization with serogroup C conjugate vaccine in 15- to 17-year-olds began on Nov 1, 1999 Cumulative cases 1998/1999 100 150 50 151015 20253035404550 0 Health Protection Agency Website. Available at: www.hpa.org.uk/infections/topics_az/meningo/graph_meni-groupC.htm. Before After During Cumulative cases 1999/2000 Cumulative cases 2000/2001 (to week 16/2001)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-31 Reductions in C-Disease in UK After Nationwide Immunization with Conjugate Vaccine Miller E, et al. Vaccine. 2002;20:S58. Age GroupCasesCasesReduction (years)1998/19992000/2001 (%) < 1811483 1 - 21192581 3 - 4671480 5 - 9752764 10 - 1474889 15 - 171211588 Total53710381

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-32 66% decrease, P = 0.001 Group C: Carriage of Meningococci in 15 to 17 Year-old School Children in the UK % with Meningococci Capsular19992000Ratio Group(N = 14,064)(N = 16,583)2000:1999 B4.114.141.01 C0.450.150.34 Y0.971.051.09 W-1351.121.421.27 Not groupable10.0511.221.12 or other groups Maiden MCJ, et al. Lancet. 2002;359:1829-30.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-33 Herd Immunity: Serogroup C Attack Rates in Unvaccinated Children Before and After UK Program Ramsay ME, et al. BMJ. 2003;326:365. July 1998–JuneJuly 2001–June 1999 Attack2002 Attack% Reduction CohortRate/100,000Rate/100,000in Unvaccinated Infants7.491.5679 Toddlers6.822.0570 Preschool3.941.2070 Grades 1 – 6 1.941.0048 Grades 7 – 105.541.1180 Older adolescents 5.281.7966

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-34 Meningococcal Polysaccharide Vaccine, A,C,Y, W-135 Combined (Menomune)  Licensed since 1982 – ages 2 and above  Indicated for travelers, occupational exposure, college students in dormitories, immune compromised persons and military recruits  85% to 87% effective in multiple outbreak studies*  Excellent safety profile  More than 20 million doses have been administered in U.S. *Menomume package insert.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-35 Expected Attributes of Menactra Vaccine in the U.S.  Persistence of protective antibody  Ability to prime and boost  Booster dose not associated with hyporesponsiveness  Reduction in carriage  Herd immunity  Replicate the UK experience in the U.S.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-36 N. meningitidis: The Next Focus for Bacterial Meningitis Prevention in the U.S. 2004 and beyond Mid 1990s to early 2000s 1980 to mid 1990s H influenzae type b (Hib) disease virtually eliminated Pneumococcal disease drastically reduced Meningococcal disease now most frequent cause of bacterial meningitis in children, adolescents, and young adults

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-38 Meningococcal Disease Epidemiology Summary  Serious and challenging public health problem  Adolescents and young adults at high risk  C conjugate vaccine largely eradicated serogroup C disease in UK  Menactra has potential to prevent up to 70% of disease in U.S. adolescents if used as part of universal immunization program targeting persons aged 11 to 18

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-40 Presentation Outline  Basis for Licensure: Non-inferiority  Measuring Immunogenicity  Overview of the Clinical Trials  Comparative Trials in Adolescents  Comparative Trials in Adults  Trials of Concomitant Administration

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-41 Basis for Licensure: Non-Inferiority of Menactra vs. Menomune  "Non-inferiority" - statistical approach commonly used when standard of care exists (ie, Menomune)  “Non-inferiority threshold” – Set at agreed margin (delta) compared to the standard – Chosen to exclude clinically important differences within a practical sample size  If non-inferior, the new intervention is considered an acceptable alternative  The evaluation of Menactra involved demonstrating its non-inferiority to Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-42 Measuring Immunogenicity Antibody Measurements  Common clinical assays measure antibody quantity – Examples: ELISA, RIA, etc.  Functional assays measure antibody performance – Less common, often more difficult to perform – Examples: Serum bactericidal antibody (SBA), CHO cell assay, etc.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-43 Evidence for the Importance of Bactericidal Antibodies in Meningococcal Disease  Gotschlich et al, Fort Dix study: serogroup C disease occurred only in individuals lacking bactericidal antibodies 1  SBA titers  1:4 correlated strongly with protection  Serum bactericidal activity could be absorbed with the group-specific capsular polysaccharide Number of Recruits Bactericidal Titer at Baseline Number of Cases Attack Rate/1000 (8 weeks) Percent Protective Effect 12,073 (82%)*  1:4 30.3 98.4% 2,668 (18%)* < 1:4 5119.1 1 Goldschneider I, Gotschlich EC, and Artenstein MS. J. Exp Med. 1969;129:1307-1326. *Based on bactericidal titer determinations of 540 non-case controls

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-44 Measuring Immunogenicity Regulatory Perspective – Correlate of Protection  1999 VRBPAC Conclusions: – Immunological data can be used to predict efficacy of meningococcal vaccines for populations for whom the current polysaccharide vaccine is licensed – Bactericidal activity may be used as a measure of functional antibody and, therefore, presumed protective activity – Total antibody measured by ELISA techniques cannot be used as a serologic correlate for functional bactericidal antibody

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-45 Measuring Immunogenicity  We will present SBA results – Standard approach for meningococcal assays – Directly relevant to protection from infection – Basis for licensure of Menomune  Assay conforms to WHO and CDC standards – Aventis Pasteur participated in the interlaboratory collaborative study – assay is fully validated – Assay uses baby rabbit complement  Difficulties with human complement – Consistency – Availability – Standardization

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-46 Measuring Immunogenicity Immunological End-Points  4-Fold Rise – % of those whose post-immunization titers are at least 4 times their pre-immunization titers – Basis for Menomune licensure – Primary (non-inferiority) outcome measure in all Menactra core clinical trials  Geometric Mean Titers – Normalized average of the post-immunization titers – Co-primary outcome measure in some of the core clinical trials; descriptive in others

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-47 Measuring Immunogenicity (2) Immunological End-Points  Seroconversion Rates – % of those initially seronegative (less than 1:8) who have a 4-fold or greater rise – Descriptive only  Reverse Cumulative Distribution Curves – Graphical presentation of the antibody distribution of the entire studied population – Descriptive only

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-48 Overview of Menactra Clinical Trials (Ages 11 to 55) Trial NumberType of StudyStudy GroupsAges (yrs)MenactraMenomune MTA02Safety &Menactra vs. 11 to 18 440441 ImmunogenicityMenomune MTA193 yr. Follow UpMenactra vs.13 to 21241- Menactra Menomune Revaccinationvs. naïve MTA04SafetyMenactra vs.11 to 18 2,270972 ComparisonMenomune MTA09Safety &Menactra vs. 18 to 55 1,3841,170 ImmunogenicityMenomune MTA14Safety &Menactra vs. 18 to 55 1,582458 Lot Consistency Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-49 Overview of Menactra Clinical Trials (Ages 11 to 55) Trial NumberType of StudyStudy GroupsAges (yrs)MenactraMenomune Total For All Trials Combined (ages 11 to 55)7,642 3,041 MTA12Safety &Menactra + Td 11 to 17509None Immunogenicity vs. of ConcomitantMenactra 1 mo512 Administrationafter TdTotal 1,021 MTA11Safety &Menactra + 18 to 55 469None Immunogenicity Typhim Vi of Concomitant vs.476 AdministrationMenactra 1 mo after Typhim ViTotal 945

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-50 AdolescentsAdults 11 – 1818 – 55Total (N = 3731)(N = 3911)(N = 7642) %% Gender Male51.436.343.6 Male51.436.343.6 Female48.663.756.4 Female48.663.756.4Race/Ethnicity White, non-Hispanic90.582.586.2 White, non-Hispanic90.582.586.2 Black, non-Hispanic4.96.96.0 Black, non-Hispanic4.96.96.0 Hispanic2.56.74.7 Hispanic2.56.74.7 Asian0.92.51.8 Asian0.92.51.8 Other1.21.41.3 Other1.21.41.3 Distribution of Clinical Trial Study Populations By Gender and Race/Ethnicity

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-51 Measuring Immunogenicity Results to be Presented  MTA02: Comparative trial in adolescents  MTA19: Three-year follow-up trial in adolescents  MTA09: Comparative trial in adults  MTA14: Lot-consistency trial in adults  MTA12: Concomitant Menactra and Td in adolescents  MTA11: Concomitant Menactra and Typhim Vi in adults

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-52 MTA02: Clinical Trial in Adolescents  Multi-center, randomized, comparative clinical trial in US adolescents  Participants: 881 healthy 11 to 18 year-olds – 440 given one i.m. dose of Menactra protein conjugate – 441 given one s.c. dose of Menomune polysaccharide  Evaluated safety and immunogenicity  Hypothesis: short-term immune response not inferior to Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-53 Menactra 392 of 423 92.7% 388 of 423 91.7% 346 of 423 81.8% 409 of 423 96.7% Menomune 391 of 423 92.4% 375 of 423 88.7% 339 of 423 80.1% 403 of 423 95.3 % 0 20 40 60 80 100 Percentage ACYW-135 MTA02: 4-Fold Rises in SBA Titer by Serogroup in Adolescents MenactraMenomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-54 MTA02: Non-inferiority Testing of 4-Fold Rises 95% CI of Difference (Menomune - Menactra) Serogroup A Within Limit Outside Limit -8 -7-6-5-4-3-2012345678910 -0.24 Serogroup C Serogroup Y Serogroup W-135 -3.07 -1.65 -1.42 1112131415 All non-inferiority criteria met

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-55 Geometric Mean Titer 0 1000 2000 3000 4000 5000 6000 ACYW-135 MTA02: Geometric Mean Titers at Day 28 by Serogroup in Adolescents Menactra5483192413221407 Menomune3246163912281545 MenactraMenomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-56Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 MTA02: RCD Curves of Day 0 and Day 28 SBA Titers in Adolescents – Serogroup A 416641024409616,38465,536256262,144832128 SBA Antibody Titers for Meningococcal Serogroup A Participants (%) 0 20 40 60 80 100

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-57 MTA02: RCD Curves of Day 0 and Day 28 SBA Titers in Adolescents – Serogroup C SBA Antibody Titers for Meningococcal Serogroup C 416641024409616,38465,536256262,144832128Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 0 20 40 60 80 100 Participants (%)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-58Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 MTA02: RCD Curves of Day 0 and Day 28 SBA Titers in Adolescents – Serogroup Y 416641024409616,38465,536256262,144832128 SBA Antibody Titers for Meningococcal Serogroup Y 0 20 40 60 80 100 Participants (%)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-59Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 MTA02: RCD Curves of Day 0 and Day 28 SBA Titers in Adolescents – Serogroup W-135 416641024409616,38465,536256262,144832128 SBA Antibody Titers for Meningococcal Serogroup W-135 0 20 40 60 80 100 Participants (%)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-61 MTA19: Menactra Booster in Adolescents  Three-year follow up and reimmunization of a subset of participants from trial MTA02  Participants: 241 healthy 14 to 21 year-olds – 76 participants with prior Menactra immunization – 77 participants with prior Menomune immunization – 88 age-matched naïve participants  Intervention: one dose of Menactra  Objectives: – Evaluate persistence of antibody over 3-year interval – Evaluate ability of Menactra to prime and to boost – Evaluate response of Menomune recipients to Menactra

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-62 MTA19: SBA GMTs of a Subset of Participants Duration of Response at 3 Years Post Vaccination 0 200 400 600 800 1000 1200 ACYW-135 Serogroup SBA GMT MenactraMenomune 1508116212482909Menomune 1586126321055192Menactra 0 1000 2000 3000 4000 5000 6000 ACYW-135 Menactra Menomune SBA GMT

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-63 MTA19: SBA GMTs of a Subset of Participants Duration of Response at 3 Years Post Vaccination P < 0.001 P = 0.12 0 200 400 600 800 1000 1200 ACYW-135 Serogroup SBA GMT MenactraMenomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-64 MTA19: SBA GMTs of a Subset of Participants Duration of Response at 3 Years Post Vaccination Age-matched Naïve 0 200 400 600 800 1000 1200 SBA GMT ACYW-135 SerogroupMenactraMenomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-65 MTA19: RCD Curves for SBA Antibody Titers for Meningococcal Serogroup A Participants (%) 100 SBA Antibody Titers for Meningococcal Serogroup A 0 20 40 60 80 416641024409616,38465,536256262,144 Group: PW Menomune at Day 0 PW Menactra at Day 0 Naïve at Day 0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-66 MTA19: RCD Curves for SBA Antibody Titers for Meningococcal Serogroup C Participants (%) 100 SBA Antibody Titers for Meningococcal Serogroup C 0 20 40 60 80 416641024409616,38465,536256262,144 Group: PW Menomune at Day 0 PW Menactra at Day 0 Naïve at Day 0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-67 MTA19: RCD Curves for SBA Antibody Titers for Meningococcal Serogroup Y Participants (%) 100 SBA Antibody Titers for Meningococcal Serogroup Y 0 20 40 60 80 416641024409616,38465,536256262,144 Group: PW Menomune at Day 0 PW Menactra at Day 0 Naïve at Day 0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-68 Participants (%) 100 SBA Antibody Titers for Meningococcal Serogroup W-135 0 20 40 60 80 416641024409616,38465,536256262,144 Group: MTA19: RCD Curves for SBA Antibody Titers for Meningococcal Serogroup W-135 PW Menomune at Day 0 PW Menactra at Day 0 Naïve at Day 0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-69 MTA19: Geometric Mean Titers Before and After Menactra, Menactra-Primed vs. Naïve – Serogroup C Menactra 0 2000 4000 6000 8000 10000 12000 14000 16000 18000 20000 Pre-boostPost-boost 8Post-boost 28 MenactraNaïve Control P < 0.001

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-70 MTA19: Geometric Mean Titers Before and After Menactra, Menactra-Primed vs. Naïve – Serogroup Y P = 0.22 P = 0.02 Menactra 0 2000 4000 6000 8000 10000 12000 14000 Pre-boostPost-boost 8Post-boost 28 MenactraNaïve Control

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-71 MTA19: Geometric Mean Titers Before and After Menactra, Menactra-Primed vs. Naïve – Serogroup W-135 P = 0.02 P = 0.01 Menactra 0 2000 4000 6000 8000 10000 12000 Pre-boostPost-boost 8Post-boost 28 MenactraNaïve Control

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-72 MTA19: Geometric Mean Titers Before and After Menactra, Menactra-Primed vs. Naïve – Serogroup A P = 0.03 P = 0.08 Menactra 0 2000 4000 6000 8000 10000 12000 14000 Pre-boostPost-boost 8Post-boost 28 MenactraNaïve Control

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-73 MTA19: SBA Primary Immunization with Menomune and Reimmunization with Menactra – C Pre-V1V1 + 28d 0 500 1000 1500 2000 2500 3000 Pre-V2 V2 + 8d V2 + 28d Menomune Three Years 0 500 1000 1500 2000 2500 3000 Menactra after Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-74 MTA19: SBA Primary Immunization with Menomune and Reimmunization with Menactra – A Menomune 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 Pre-V1V1 + 28d Three Years Pre-V2 V2 + 8d V2 + 28d 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 Menactra after Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-75 MTA19: SBA Primary Immunization with Menomune and Reimmunization with Menactra – Y 0 500 1000 1500 2000 2500 3000 3500 Menomune Pre-V1V1 + 28dPre-V2 V2 + 8d V2 + 28d 0 500 1000 1500 2000 2500 3000 3500 Three Years Menomune Menactra after Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-76 MTA19: SBA Primary Immunization with Menomune and Reimmunization with Menactra – W-135 0 500 1000 1500 2000 2500 Pre-V1V1 + 28dPre-V2 V2 + 8d V2 + 28d Menactra after MenomuneMenomune Three Years 0 500 1000 1500 2000 2500 Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-77 MTA19: Summary and Conclusions  Superior persistence of antibody – At 3 years, Menactra SBA GMTs are higher than seen following Menomune or in naïve controls  Ability of Menactra to prime and to boost – Rapid, high anamnestic response, far exceeding response of naïve controls, demonstrates priming, memory, and boosting  Response of Menomune recipients to Menactra – Prior Menomune recipients given Menactra demonstrate a rapid increase in bactericidal antibody, to levels exceeding those that would be expected if reimmunized with Menomune  Conclusion: Menactra demonstrates the important immunologic characteristics expected of a conjugate vaccine

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-79 MTA09: Clinical Trial in Adults  Multi-center, randomized, comparative clinical trial in adults  Participants: 2,554 healthy 18 to 55 year-olds – 1,384 given one i.m. dose of Menactra protein conjugate – 1,170 given one s.c. dose of Menomune polysaccharide  Evaluated safety and immunogenicity  Hypothesis: short-term immune response not inferior to Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-80 MTA09: 4-Fold Rises in SBA Titer by Serogroup in Adults Menactra 1030 of 1280 80.5% 1133 of 1280 88.5% 941 of 1280 73.5% 1144 of 1280 89.4% Menomune 929 of 1098 84.6% 985 of 1098 89.7% 872 of 1098 79.4% 1036 of 1098 94.4% 0 20 40 60 80 100 ACYW-135 Percentage Menactra Menomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-81 Serogroup A Within Limit Outside Limit -2012345678910 4.1 Serogroup C Serogroup Y Serogroup W-135 1.2 5.9 5.0 1112131415 MTA09: Non-inferiority Testing of 4-Fold Rises 95% CI of Difference (Menomune – Menactra) All non-inferiority criteria met

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-82 0 500 1000 1500 2000 2500 3000 3500 4000 4500 Geometric Mean Titer ACYW-135 Menactra3897323117501271 Menomune4114346924491871 MTA09: Geometric Mean Titers at Day 28 by Serogroup in Adults MenactraMenomune

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-83 Serogroup A Within Limit Outside Limit 0.500.751.001.251.501.752.002.252.50 1.07 Serogroup C Serogroup Y Serogroup W-135 1.10 1.50 1.39 MTA09: Non-Inferiority Testing of the Ratio of GMTs* 95% CI of the Ratio (Menomune/Menactra) All non-inferiority criteria met *Adjusted for baseline titers using ANCOVA.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-84 MTA09: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup C Participants (%) SBA Antibody Titers for Meningococcal Serogroup C 416641024409616,38465,536256262,144 0 20 40 60 80 100 832128Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-85 Participants (%) SBA Antibody Titers for Meningococcal Serogroup A Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 MTA09: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup A 0 20 40 60 80 100 416641024409616,38465,536256262,144832128

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-86 Participants (%) Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 MTA09: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup Y 0 20 40 60 80 100 416641024409616,38465,536256262,144832128 SBA Antibody Titers for Meningococcal Serogroup Y

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-87 Participants (%) Group: Menactra, Day 0 Menomune, Day 0 Menactra, Day 28 Menomune, Day 28 MTA09: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup W-135 0 20 40 60 80 100 SBA Antibody Titers for Meningococcal Serogroup W-135 416641024409616,38465,536256262,144832128

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-89 MTA14: Lot-Consistency Trial in Adults  Multi-center, randomized, lot-consistency and comparative clinical trial in US adults  Participants: 2,040 healthy 18 to 55 year-olds – 1582 given one i.m. dose of Menactra protein conjugate (divided evenly among 3 vaccine lots) – 458 given one s.c. dose of Menomune polysaccharide  Evaluated immunogenicity (lot consistency) and safety (in 26 to 55 year-olds)  Hypothesis: equivalence of three Menactra lots (maximum ratio, 1.5)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-90 Geometric Mean Titer MTA14: Geometric Mean Titers at Day 28 by Serogroup in Adults Menactra Lot 1 8169386828982031 Menactra Lot 2 8215415524722573 Menactra Lot 3 6679321738052457 A C Y W-135 0 1000 2000 3000 4000 5000 6000 7000 8000 9000 Menactra Lot 1 Menactra Lot 2 Menactra Lot 3

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-91 MTA14: Equivalence Testing of the Ratio of GMTs* 90% CI of the Ratio (Lot 1/Lot 2, Lot 1/Lot 3, Lot 2/Lot 3) Within Limit Outside Limit 1.51.752.00 1.01 Serogroup A Lot 1/2 Lot 1/3 Lot 2/3 Serogroup C Serogroup Y Serogroup W-135 Outside Limit.66.50.25 1.23 Lot 1/2 Lot 1/3 Lot 2/3 Lot 1/2 Lot 1/3 Lot 2/3 Lot 1/2 Lot 1/3 Lot 2/3 1.22 0.89 1.22 1.37 0.79 1.02 0.73 1.09 0.67 0.81 *Adjusted for baseline titers using ANCOVA.

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-92 MTA14: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup A SBA Antibody Titers for Meningococcal Serogroup A Group: Menactra Lot 2 Group at Day 28 Menactra Lot 2 Group at Day 0 Menactra Lot 1 Group at Day 28 Menactra Lot 1 Group at Day 0 Menactra Lot 3 Group at Day 28 Menactra Lot 3 Group at Day 0 Participants (%) 0 20 40 60 80 100 416641024409616,38465,536256262,144

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-93 MTA14: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup C Group: Menactra Lot 2 Group at Day 28 Menactra Lot 2 Group at Day 0 Menactra Lot 1 Group at Day 28 Menactra Lot 1 Group at Day 0 Menactra Lot 3 Group at Day 28 Menactra Lot 3 Group at Day 0 Participants (%) 0 20 40 60 80 100 416641024409616,38465,536256262,144 SBA Antibody Titers for Meningococcal Serogroup C

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-94 MTA14: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup Y Group: Menactra Lot 2 Group at Day 28 Menactra Lot 2 Group at Day 0 Menactra Lot 1 Group at Day 28 Menactra Lot 1 Group at Day 0 Menactra Lot 3 Group at Day 28 Menactra Lot 3 Group at Day 0 Participants (%) 0 20 40 60 80 100 416641024409616,38465,536256262,144 SBA Antibody Titers for Meningococcal Serogroup Y

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-95 MTA14: RCD Curves of Day 0 and Day 28 SBA Titers in Adults – Serogroup W-135 Participants (%) 0 20 40 60 80 100 416641024409616,38465,536256262,144 Group: Menactra Lot 2 Group at Day 28 Menactra Lot 2 Group at Day 0 Menactra Lot 1 Group at Day 28 Menactra Lot 1 Group at Day 0 Menactra Lot 3 Group at Day 28 Menactra Lot 3 Group at Day 0 SBA Antibody Titers for Meningococcal Serogroup W-135

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-96 MTA14: Summary of Results for the Consistency Lots By Serogroup SerogroupLotGMT % 4-Fold %  128 A1816985100 2821585100 3667982100 C138688697 241558999 332178397 Y128987599 224727298 338058198 W-135120318697 225738896 324579298

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-98 MTA12: Concomitant Menactra and Td Clinical Trial in Adolescents  Multi-center, randomized, comparative clinical trial in US adolescents  Participants: 1,021 healthy 11 to 17 year-olds – 509 given Menactra + Td followed 28 days later by placebo – 512 given Td + placebo followed 28 days later by Menactra  Evaluated safety and immunogenicity  Hypothesis: concomitant administration is not inferior to sequential administration

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-99 MTA12: 4-Fold Rise in SBA Titer by Serogroup 0 20 40 60 80 100 ACYW-135 Menactra + Td Menactra 28 days after Td Menactra + Td 419 of 465 (90.1%) 424 of 465 (91.2%) 399 of 465 (85.8%) 448 of 465 (96.3%) Menactra 28 days after Td 433 of 478 (90.6%) 394 of 478 (82.4%) 311 of 478 (65.1%) 419 of 478 (87.7%) Percentage

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-100 Serogroup A Within Limit Outside Limit -30-25-20-15-10-50510 0.48 Serogroup C Serogroup Y Serogroup W-135 -8.76 -20.74 -8.69 15 MTA12: Non-inferiority Testing of 4-Fold Rises 95% CI of the Difference (Sequential - Simultaneous) All non-inferiority criteria met 2025

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-101 MTA12: Geometric Mean Titers Level Comparison 28 Days Post Menactra Vaccination 1 10 100 1000 10000 100000 Menactra + Td Menactra 28 days after Td Geometric Mean Titer (log scale) ACYW-135 Menactra + Td 11,313505933914195 Menactra 28 days after Td 10,391213613311339

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-102 MTA12: Geometric Mean Titers 28 Days Post Menactra Vaccination MTA025483192413221407 Menactra + Td 11,313505933914195 Menactra 28 days after Td 10,391213613311339 1 10 100 1000 10000 100000 ACYW-135 Menactra / MTA02 Menactra + Td Menactra 28 days after Td Geometric Mean Titer (log scale)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-103 MTA12: Percent Tetanus Antibody Response 2-Fold (Pre-titer > 2.7 IU/mL) 18/49(36.7%)17/45(37.8%) 4-Fold (Pre-titer  2.7 IU/mL) 391/413(94.7%)408/426(95.8%) Total Responders 409/462(88.5%)425/471(90.2%) Menactra + TdTd + Placebo 2-Fold Responders 4-Fold Responders Total Responders Percentage 0 20 40 60 80 100

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-104 MTA12: Percent Diphtheria Antibody Response Menactra + TdTd + Placebo 0 20 40 60 80 100 Percentage 2-Fold Responders 4-Fold Responders Total Responders 2-Fold (Pre-titer > 2.56 IU/mL) 8/8 (100.0%) 7/13 (53.9%) 4-Fold (Pre-titer  2.56 IU/mL) 454/456 (99.6%) 439/458 (95.9%) Total Responders 462/464 (99.6%) 446/471 (94.7%)

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-105 MTA12: Non-Inferiority Testing of Response Rates 95% CI of the Difference (Sequential - Simultaneous) Tetanus Within Limit Outside Limit -8 -7-6-5-4-3-2012345678910 1.71 Diphtheria -4.88 1112131415 All non-inferiority criteria met

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-107 MTA11: Concomitant Typhim Vi and Menactra Clinical Trial in Adults  Multi-center, randomized, comparative clinical trial in US adults  Participants: 945 healthy 18 to 55 year-olds – 469 given Typhim Vi + Menactra followed 28 days later by placebo – 476 given Typhim Vi + placebo followed 28 days later by Menactra  Evaluated safety and immunogenicity  Hypothesis: concomitant administration is not inferior to sequential administration

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-108 0 2000 4000 6000 8000 ACYW-135 Menactra + Typhim Vi Menactra 28 days after Typhim Vi Geometric Mean Titer Menactra + Typhim Vi 5138306118211002 Menactra 28 days after Typhim Vi 511031451742929 MTA11: Geometric Mean Titers at Day 28 after Menactra in Adults

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-109 MTA11: 4-Fold Rises in SBA Titer by Serogroup in Adults 0 20 40 60 80 100 ACYW-135 Menactra + Typhim Vi Menactra 28 days after Typhim Vi Menactra + Typhim Vi 333 of 418 (79.7%) 374 of 418 (89.5%) 311 of 418 (74.4%) 356 of 418 (85.2%) Menactra 28 days after Typhim Vi 315 of 419 (75.2%) 370 of 419 (88.3%) 273 of 419 (65.2%) 351 of 419 (83.8%) Percentage

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-110 MTA11: Non-Inferiority Testing of 4-Fold Rises 95% CI of the Difference (Sequential - Simultaneous) Serogroup A Within Limit Outside Limit -30-25-20-15-10-50510 -4.49 Serogroup C Serogroup Y Serogroup W-135 -1.17 -9.25 -1.40 15 All non-inferiority criteria met 2025

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-111 MTA11: Proportion of Participants with Typhim Vi Antibody Titer >1.0 µg/mL at 28 Days Post-Vaccination Menactra + Typhim Vi Typhim Vi + Placebo 341 of 418 (81.6%) 328 of 418 (78.5%) 0 20 40 60 80 100 Menactra + Typhim Vi Typhim Vi + Placebo Percentage

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-112 MTA11: Non-Inferiority Testing of the Percentage >1.0 µg/mL 95% CI of the Difference (Sequential – Simultaneous) Within Limit Outside Limit -8 -7-6-5-4-3-2012345678910 -3.11 1112131415 All non-inferiority criteria met -9 Typhim Vi + Placebo vs. Menactra + Typhim Vi

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-113 Menactra Immunogenicity: Conclusions  Menactra is consistently immunogenic in adolescents and adults, satisfying all non-inferiority criteria  Menactra SBAs after 3 years are superior to those seen following Menomune or in naïve controls  One dose of Menactra primes for memory, as demonstrated by a rapid and very high booster response upon reimmunization  Menactra offers a superior reimmunization pathway for prior Menomune recipients  Menactra demonstrates the important immunologic characteristics expected of a conjugate vaccine

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-115 Objectives for the Evaluation of the Safety Profile of Menactra  To compare safety profile of Menactra to safety profile of Menomune – Demonstrate that rate of severe solicited systemic reactions reported in Menactra and Menomune recipients are comparable  To characterize overall safety profile of Menactra

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-116 Safety Data Collected  Immediate reactions collected 0 to 30 minutes  Solicited systemic and local reactions collected Day 0 through Day 7  Unsolicited adverse events – Days 0 to 28 – Day 29 to month 6  Serious adverse events

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-117 Presentation Outline  Immediate Reactions  Solicited Systemic Reactions  Adolescents – MTA04, MTA02 & MTA12  Adults – MTA09, MTA14 & MTA11  Solicited Local Reactions  Adolescents – MTA04, MTA02 & MTA12  Adults – MTA09, MTA14 & MTA11  Unsolicited Adverse Events and SAEs  Conclusions

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-118 Immediate Reactions Menactra (N = 7642) Menomune (N = 3041) n%n% At least one reaction230.360.2 Syncope (5 Vasovagal) 80.100 Dizziness60.110 Sweating40.110 Nausea3000 Vomiting2000 Injection site reaction 2020.1 Injection site edema 1010 Injection site inflammation 1000 Chills1000 Fever1000 Increased cough 0020.1 Laryngismus0010 Pharyngitis0010

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-120 Solicited Systemic Adverse Events: All Trials  Pre-established list of systemic medical conditions – Fever, chills, headache, anorexia, vomiting, diarrhea, fatigue, malaise, arthralgia, seizures, rash  Clinical severity documented according to defined rating scale (mild, moderate, severe)  Information recorded Day 0 through Day 7  Presence of events and intensity recorded daily on the diary

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-121 Safety Hypothesis: Systemic Expected rate in the control group = 1% Menactra is non-inferior to Menomune in the proportion of participants with at least one severe solicited systemic reaction reported during Day 0 through Day 7. Non-inferiority criteria: MTA04 & MTA09: upper limitMTA02 & MTA14: upper limit of of the two-sided 95% CI of thethe two-sided 95% Cl of the ratio p Menactra / p Menomune < 3difference p Menactra – p Menomune < 0.1

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-123 MTA04: Solicited Systemic Reactions in Adolescents Menactra (N = 2265) % Menomune (N = 970) % Participants with any systemic reaction 55.148.7 Participants with any severe systemic reactions 4.32.6

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-124 MTA04: Non-inferiority Testing of Severe Systemic Reactions, 95% CI of Ratio (Menactra/Menomune) 1.66 3.03.50.51.01.52.02.50.751.251.752.252.753.253.75 Within Limit Outside Limit Non-inferiority criteria met

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-125 MTA04: Systemic Reaction Profile in Adolescents Menactra (N = 2265) %Menomune (N = 970) % Headache35.629.3 Fatigue30.025.1 Malaise21.916.8 Arthralgia17.410.2 Diarrhea12.010.2 Anorexia10.77.7 Chills7.03.5 Fever5.13.0 Vomiting1.91.4 Rash1.61.4 Seizures00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-126 MTA04: Severe Solicited Systemic Reactions in Adolescents Menactra (N = 2265) %Menomune (N = 970) % Rash1.61.4 Headache1.1*0.4 Fatigue1.1*0.2 Malaise1.1*0.4 Arthralgia0.40.1 Anorexia0.30.2 Diarrhea0.3*0 Vomiting0.30.3 Chills0.20.1 Fever00.1 Seizures00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-127 MTA02: Solicited Systemic Reactions in Adolescents Menactra (N = 439) % Menomune (N = 441) % Participants with any systemic reaction 57.251.9 Participants with any severe systemic reactions 3.94.1

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-129 MTA02: Systemic Reaction Profile in Adolescents Menactra (N = 439) %Menomune (N = 441) % Headache44.939.5 Fatigue28.223.6 Anorexia12.312.2 Diarrhea10.914.1 Fever3.42.5 Vomiting2.32.0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-130 MTA02: Severe Solicited Systemic Reactions in Adolescents Menactra (N = 439) %Menomune (N = 441) % Rash1.61.6 Headache1.61.8 Fatigue1.10.7 Anorexia0.90.7 Diarrhea00.2 Vomiting0.20.2 Fever0.20

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-131 Solicited Systemic Reactions: Adolescents MTA12MTA04MTA02 Td + Menactra (N = 505) %Td + Placebo (N = 510) % (N = 2265) % (N = 439) % Solicited systemic reactions 58.654.155.157.2 Severe solicited systemic reactions 4.83.74.33.9

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-133 MTA09: Solicited Systemic Reactions in Adults Menactra (N = 1371) % Menomune (N = 1159) % Participants with any systemic reaction 61.960.3 Participants with any severe systemic reactions 3.82.6

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-135 MTA09: Systemic Reaction Profile in Adults Menactra (N = 1371) % Menomune (N = 1159) % Headache41.441.8 Fatigue34.732.3 Malaise23.622.3 Arthralgia19.816.0 Diarrhea16.014.0 Anorexia11.89.9 Chills9.75.6 Vomiting2.31.5 Fever1.50.5 Rash1.40.8 Seizures00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-136 MTA09: Severe Solicited Systemic Reactions in Adults Menactra (N = 1371) % Menomune (N = 1159) % Rash1.40.8 Headache1.20.9 Malaise1.10.9 Fatigue0.90.4 Chills0.6*0 Anorexia0.40.4 Diarrhea0.40.3 Arthralgia0.30.1 Vomiting0.20.4 Fever00 Seizures00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-137 MTA14: Solicited Systemic Reactions in Adults Menactra (N = 685) % Menomune (N = 455) % Participants with any systemic reaction 53.449.2 Participants with any severe systemic reactions 2.25.5

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-138 0.40 3.03.50.51.01.52.02.50.751.251.752.252.753.25 Within Limit Outside Limit MTA14: Non-inferiority Testing of Severe Systemic Reactions, 95% CI of Ratio (Menactra/Menomune) 0.25 Non-inferiority criteria met

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-139 MTA14: Systemic Reaction Profile in Adults Menactra (N = 685) % Menomune (N = 455) % Headache35.033.6 Fatigue28.025.1 Malaise19.617.6 Diarrhea15.315.4 Arthralgia15.212.5 Anorexia9.37.7 Chills6.63.3 Vomiting1.21.3 Fever0.60.4 Rash1.02.4 Seizure00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-140 MTA14: Severe Solicited Systemic Reactions in Adults Menactra (N = 685) %Menomune (N = 455) % Rash1.02.4 Headache0.41.1 Malaise0.31.8* Fatigue0.61.3 Chills00.4 Anorexia0.10.2 Diarrhea0.30.7 Arthralgia00.4 Vomiting00 Fever00 Seizure00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-141 Solicited Systemic Reactions: Adults MTA11MTA09MTA14 Typhim Vi + Menactra (N = 456) % Typhim Vi + Placebo (N = 470) % (N = 1371) % (N = 685) % Solicited systemic reactions 60.559.661.953.4 Severe solicited systemic reactions 5.31.53.82.2

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-143 Solicited Local Reactions  Pre-established list of vaccine injection site reactions – Redness, swelling, induration, pain at the injection site  Clinical severity documented – Mild, moderate, or severe  Information recorded on pre-printed diary on Day 0 through Day 7

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-144 Local Reactions: Intensity Scale Pain at injection site:  0 =None  1 =Mild: symptom present, but arm movement was not affected  2 =Moderate: discomfort, interferes with or limits arm movement  3 =Severe: too painful to move arm Induration, swelling and redness:  0 =None  1 =Mild: < 1.0 inch  2 =Moderate: 1.0 – 2.0 inches  3 =Severe: > 2.0 inches

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-146 MTA04/MTA02/MTA12: Adolescents Pain at Injection Site MenomuneMenactraTdPlacebo Any (range), % 28.7 – 30.2 52.9 – 68.9 70.9 – 71.0 15.5 – 22.7 Severe (range), % 0 0 – 0.8 0.20 Duration Any (median in days) 1.02.0 2.0 – 3.0 1.0 Severe Portion (median in days) 01.01.00

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-147 MTA04/MTA02/MTA12: Adolescents Induration, Swelling, Redness MenomuneMenactraTdPlacebo Any (range), % 3.6 – 7.7 10.8 – 20.3 14.5 – 25.9 1.6 – 7.6 Severe (range), % 0 0.2 – 1.4 0.2 – 1.6 0 – 0.2 Duration Any (median in days) 1.0 1.0 – 2.0 Severe Portion (median in days) 0 1.0 – 2.0 1.01.0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-148 72.4 57.0 73.3 58.0 74.7 Adolescent Local Reactions 0 10 20 30 40 50 60 70 80 90 100 Local Reactions % of Participants Reporting 62.7 MTA12: Td Site Given w/Menactra MTA12: Menactra Site Given w/ Td MTA12: Td Given w/Placebo MTA12: Menactra Site Given One Month after Td MTA02: Menactra MTA04: Menactra

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-150 MTA09/MTA14/MTA11: Adults Pain at Injection Site MenomuneMenactra Typhim Vi Placebo Any (range), % 19.8 – 48.1 38.5 – 53.9 75.2 – 75.7 13.6 – 21.9 Severe (range), % 0 – 0.1 0 – 1.8 0.4 – 0.6 0 – 0.2 Duration Any (median in days) 1.02.02.02.0 Severe Portion (median in days) 0 – 1.0 1.5 – 2.0 2.5 0 – 1.0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-151 MTA09/MTA14/MTA11: Adults Induration, Swelling, Redness MenomuneMenactra Typhim Vi Placebo Any (range), % 4.6 – 16.0 10.5 – 17.1 14.0 – 21.7 2.8 – 6.0 Severe (range), % 0 – 0.1 0.4 – 1.1 0 – 0.4 0 – 0.2 Duration Any (median in days) 1.0 – 2.0 2.01.01.0 Severe Portion (median in days) 0 – 1.0 1.0 – 3.0 1.0 0 – 3.0

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-152 57.6 47.2 77.4 51.3 77.4 Adult Local Reactions 0 10 20 30 40 50 60 70 80 90 100 Local Reactions MTA11: Typhim Vi Site Given w/Menactra MTA11: Menactra Site Given w/ Typhim Vi MTA11: Typhim Vi Given w/Placebo MTA11: Menactra Site Given One Month after Typhim Vi MTA09: Menactra MTA14: Menactra 42.3 % of Participants Reporting

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-154 Most Frequent Unsolicited AEs That Occurred in at Least 1% of Participants, Day 0 to Day 28 MenactraMenomune COSTART Body System/(N = 7500) (N = 3004) Preferred Term% % At least one unsolicited AE28.328.6 Body as a whole Infection2.94.1 Pain2.01.9 Injury accidental1.91.9 Pain back1.81.4 Allergic reaction1.61.6 Headache1.21.3 Pain abdominal0.81.2 Respiratory system Pharyngitis3.74.4 Rhinitis2.93.4 Cough increasing1.61.2 Sinusitis1.11.0 Urogenital system Dysmenorrhea3.13.3 Digestive System Dyspepsia0.91.5

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-155 Unsolicited Adverse Events, Day 29 to Month 6 Menactra (N = 5676) % Menomune (N = 3041) % At least one unsolicited AE 5.85.7 Body as a whole 2.21.5 Skin and appendages 1.00.8 Respiratory system 1.0 Urogenital system 0.8 Musculoskeletal system 0.5 Digestive system 0.40.5 Nervous system 0.40.5 Hemic and lymphatic system 0.3 Cardiovascular system 0.20.3 Special senses 0.20.3 Metabolic and nutritional disorders 0.1 Endocrine system 00.1

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-156 SAEs – All Trials  Total participants reporting SAEs – Menactra – 77 (1.0%) – Menomune – 39 (1.3%)  All except one reported as unrelated to study vaccine – 17 y/o with distal esophageal ulceration  Presented with symptoms 2 days after vaccination  History of NSAID use for 4 weeks prior to vaccination to treat sport-related injury

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-157 Deaths  Two deaths reported across the six studies – Both in study MTA14  Both classified by investigator as unrelated to study vaccine – One in Menactra group  Motor vehicle accident 109 days after vaccination – One in Menomune group  Drug overdose 79 days after vaccination

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-159 Conclusions – Safety  Menactra safe and well tolerated among adolescents and adults  Menactra met all agreed non-inferiority criteria  Local reactions seen with Menactra as expected for protein conjugate vaccine and comparable to those seen with Td  Menactra may be administered either concomitantly or one month after Td or Typhim Vi

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-161 Conclusions – Immunogenicity  Menactra consistently immunogenic in adolescents and adults  Immune responses to the four meningococcal serogroups included in Menactra non-inferior to those induced by Menomune  Menactra can be administered concomitantly or one month after Td or Typhim Vi

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-162 Conclusions – Immunogenicity (2)  Bactericidal antibody elicited by single dose of Menactra persists for at least three years  One dose of Menactra primes for memory  Adolescents primed with one dose of Menactra exhibited booster response to second dose  Booster dose of Menactra not associated with hyporesponsiveness

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-163 Conclusions – Safety  Menactra safe and well-tolerated among adolescents and adults  Menactra met all agreed non-inferiority criteria  Local reactions as expected for protein- conjugate vaccine and comparable to those seen with Td  Menactra may be administered concomitantly or one month after Td or Typhim Vi

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-164 Risk/Benefit Risks  Reactogenicity profile consistent with conjugate vaccine – Increased rate of local reactions Benefits  Highly immunogenic  Improved antibody persistence  Priming and boosting  Overcomes hyporesponsiveness

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-165 MenomuneVaccineesMenactraVaccinees SBA-BRC 4-Fold Rise 73 of 81 90% 75 of 84 89% SBA-HuC  1:4 70 of 81 86% 79 of 84 94% Bactericidal Titers Comparison:  4-Fold Rise (BRC) vs.  1:4 (HuC), Serogroup C 11 to 18 year olds (MTA02) Percentage SBA-BRC (4-fold rise) SBA-HuC (  1:4) 0 20 40 60 80 100

Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-1 MENACTRA ™ Meningococcal.

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Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-1 MENACTRA ™ Meningococcal.

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Presentation on theme: "Menactra  is a trademark of Aventis Pasteur Inc. Menomune ®, Tripedia ® and Typhim Vi ® are registered trademarks of Aventis Pasteur. C-1 MENACTRA ™ Meningococcal."— Presentation transcript:

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