Pfizer’s phase 3 trial evaluating the safety, tolerability, and immunogenicity of an investigational pentavalent meningococcal vaccine (MenABCWY) in healthy adolescents and young adults met all primary and secondary endpoints.
The randomized, active-controlled, observer-blinded trial (ClinicalTrials.gov Identifier: NCT04440163) included 2341 healthy individuals 10 through 25 years of age. Participants were randomly assigned to receive either 2 doses of MenABCWY or licensed meningococcal vaccines (2 doses of Trumenba® plus 1 dose of Menveo®).
Results showed that 2 doses of MenABCWY met the primary endpoint demonstrating noninferiority for all 5 serogroups (serogroups A, B, C, W and Y) compared with 2 doses of Trumenba and 1 dose of Menveo. Noninferiority was also demonstrated for serogroups A, C, W and Y with a single dose of MenABCWY compared with 1 dose of Menveo (secondary endpoint).
Among participants who had not previously received a meningococcal vaccine, the proportion of individuals with 4-fold or greater increases in immune responses was observed to be higher following MenABCWY vaccination (1 or 2 doses) for serogroups A, C, W and Y compared with 1 dose of Menveo.
Additionally, when compared with 2 doses of Trumenba, the proportion of individuals with 4-fold or greater increases in immune responses was found to be higher against all 4 serogroup B strains following 2 doses of MenABCWY.
“We are very pleased with these positive phase 3 data, which are the first for a MenABCWY vaccine candidate,” said Annaliesa Anderson, PhD, Senior Vice President and CSO, Vaccine Research and Development, Pfizer. “A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the US and improve vaccine coverage.”
The Company intends to submit a Biologics License Application to the Food and Drug Administration in the fourth quarter of 2022.
Pfizer announces positive top-line results from phase 3 trial of pentavalent meningococcal vaccine candidate (MenABCWY) in adolescents. News release. Pfizer. Accessed September 15, 2022. https://www.businesswire.com/news/home/20220914006052/en/Pfizer-Announces-Positive-Top-Line-Results-from-Phase-3-Trial-of-Pentavalent-Meningococcal-Vaccine-Candidate-MenABCWY-in-Adolescents