MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

Summary

The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.

Timeline

Start

2020-06-17

Primary completion

2022-07-24

Completion

2022-07-24

Outcome

Met primary endpoint

paper lower bounds of the 95% CIs for the differences in rates of seroresponse or composite response (all MenB strains combined) exceeded -10%. PMID 42314722 ↗

registry Difference in percentage of participants 9.6 (95% CI 4.2 to 15.2) NCT04440163 ↗

release “Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba ® and one dose of Menveo ®.” pfizer.com ↗

release “Non-inferiority was demonstrated for all five serogroups following two doses of MenABCWY compared to two doses of Trumenba ® and one dose of Menveo ® .” pfizer.com ↗

Publications

• Ostergaard L, Czajka H, Roque-Guerrero L, Maguire JD, Pregaldien JL, Zolotas L, Moughan B, Maansson R, O'Neil R, Balmer P, Jodar L, Gruber WC, Anderson AS, Scott DA, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal MenABCWY vaccine in healthy adolescents and young adults: a phase 3, multicountry, randomised, observer-blinded, active-controlled non-inferiority trial. Lancet Child Adolesc Health. 2026 Aug;10(8):584-596. doi: 10.1016/S2352-4642(26)00095-7. Epub 2026 Jun 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MenABCWY	Vaccine	—	—
Subject	MenACWY-CRM	Vaccine	—	—
Subject	Trumenba	Vaccine	—	—

Indications