National Center for Immunization & Respiratory Diseases

Work Group Interpretation of Pfiz

MenABCWY Vaccine Clinical Trials 

Sam Crowe, PhD, MPH

Meningococcal Vaccines Work Group Lead

February 23, 2023
Policy Questions for Each Pentavalent Vaccin

 Should the pentavalent vaccine be included as an option for 

MenACWY/MenB vaccination in people currently recommendboth vaccines?

– For example, 16 year olds

1

 Should the pentavalent vaccine be included as an option for p

currently recommended to receive MenACWY only?

– For example, 11–12 year olds

 Should the pentavalent vaccine be included as an option for p

currently recommended to receive MenB only?

– For example, during a serogroup B outbreak

1 16 year olds who decide to receive the MenB vaccine based on shared clinical decision-making
Pfizer MenABCWY Vaccine and Trials Overvie

 Comprised of Nimenrix (serogroups ACWY) and Trumenba (serogro

– Trumenba currently licensed and available in US, 10y through 25y– Nimenrix not licensed in US but used extensively elsewhere, 6w and ol

 Two clinical trials completed (NCT03135834, NCT04440163)

– Assessed safety and immunogenicity of pentavalent vaccine– Compared to Trumenba (MenB) and Menveo (MenACWY)– Included participants 10 through 25 years of age– Studied single and two dose (0, 6m) schedules – 4-year persistence and booster dose were evaluated

 Extended interval study underway (NCT04440176)

– Study arm 1 — 0, 12m (data available)– Study arm 2 — 0, 36m
Safety

 Assessed by monitoring for and comparing local reactions, systemic 

medically attended adverse events, serious adverse events, and nechronic medical conditions

 Local reactions within 7 days after vaccination – Includes pain, redness, swelling – Comparison between pentavalent and MenB vaccine only – Slightly higher percentage of participants had a local reaction to pentav

both 1st and 2nd doses

 Systemic events within 7 days after vaccination – Includes fatigue, headache, muscle pain, joint pain, chills, diarrhea, vom

– Similar percentage of participants experienced systemic events in pent

group and in MenACWY+MenB group – Percentage varied slightly between groups by systemic event and by do
Safety, Continued

 Medically attended adverse events – Similar percentages between study groups (both <15%) Serious adverse events – More reported for pentavalent group (0.4% vs. 0%) – None assessed to be related to pentavalent vaccine (e.g., hospitalizatio

medical conditions) 

 Newly diagnosed chronic medical conditions (NDCMC) – More reported for pentavalent group (1.1% vs. 0.3%) – Higher number of participants with attention-deficit/hyperactivity diso

pentavalent group – most with related symptoms before entering stud

 Higher risk patients (e.g., complement deficiency) not included in trials
Immunogenicity Standards

 Serogroups A, C, W, and Y

– Percentage of participants achieving MenACWY seroresp

titer 1 month after 1 dose and 1 month after 2 doses

– Seroresponse is defined as a 4-fold increase in titer over 

 Serogroup B

– Percentage of participants achieving MenB seroresponse 

month after 2 doses

– Composite response provided– Seroresponse is defined as a 4-fold increase in titer over 
Immunogenicity for Serogroups A, C, W, Y

 1 dose of the pentavalent vaccine is noninferior to 1 dose of MenA

ACWY-naïve and ACWY-primed participants 1 month after administ

ACWY-Naive ACWY-Primed
Immunogenicity for Serogroups A, C, W, Y

 2 doses of the pentavalent vaccine given 6 months apart are nonin

of MenACWY in both naïve and primed participants 1 month after 

ACWY-Naive ACWY-Primed
Seroprotection for ACWY-Naïve Participants after 4 

 Seroprotection persists up to 4 years in naïve participants after a 2-
Seroprotection for ACWY-Primed Participants after 4 

 Seroprotection persists up to 4 years in primed participants after a 
Immunogenicity for Serogroup B

 2 doses of the pentavalent vaccine given 6 months apart are nonin

of MenB in naïve participants (primed not assessed)
Seroprotection for Serogroup B-Naïve Partici

 Waning of immunity for the pentavalent vaccine is very similar to t

with MenB, dropping substantially by 12 months post-dose 2
Additional Work Group Reflections

 Data not presented on 3-dose schedule of pentavalent vacci

– 3-dose schedule of Trumenba currently recommended fo

high-risk groups (e.g., people affected by a serogroup B o

 Data not available in people older than 25 years

– MenB vaccines licensed for 10–25 years– MenACWY vaccines licensed up to 55 years or older dep

vaccine
Final Reflections and Next Steps

 Pfizer’s MenABCWY vaccine appears to be noninferior to MenACW

on clinical trial data presented

 Data gaps

– 3-dose schedule for high-risk populations– Adults older than 25 years

 Next steps

– Reviewing additional immunologic persistence data for a single – GRADE and EtR — will focus on pentavalent vaccine studies– Cost effectiveness study will be conducted
For more information, contact CDC

1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.govThe findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.