Positive topline results were announced from a phase 3 study evaluating the safety and immunogenicity of Prevnar 20 (pneumococcal 20-valent conjugate vaccine) administered with the seasonal influenza vaccine (Fluad Quadrivalent [adjuvanted], 2020/2021 strains) in adults 65 years of age and older.
The randomized, double-blind trial (ClinicalTrials.gov Identifier: NCT04526574) enrolled a total of 1796 participants, of which 1727 completed the study. Participants were randomly assigned to receive either the Prevnar 20 and seasonal influenza vaccine at the same visit followed by a saline injection 1 month later or saline injection and seasonal influenza vaccine at the same visit followed by Prevnar 20 one month later.
Findings demonstrated that the administration of Prevnar 20 with seasonal influenza vaccine elicited responses that were noninferior to those observed when the vaccines were administered 1 month apart. Moreover, the safety profile of Prevnar 20 was found to be similar when the vaccines were administered together compared with when the vaccines were administered 1 month apart.
“We are encouraged by these results showing that these 2 vaccines can be administered at the same time without affecting the immune protection provided by either vaccine or changing the safety profile,” said Kathrin U. Jansen, PhD, Senior Vice President and Head of Vaccine Research & Development, Pfizer. “This study adds to the body of evidence further supporting that pneumococcal conjugate vaccines may be coadministered with influenza vaccines, this time studied with the adjuvanted influenza vaccine.”
The Company is also conducting a phase 3 trial investigating the safety and immunogenicity of Prevnar 20 coadministered with a booster dose of Comirnaty (COVID-19 vaccine, mRNA) in adults 65 years of age and older.
Positive top-line results of Pfizer’s phase 3 study exploring coadministration of Prevnar 20™ with seasonal flu vaccine in older adults released. News release. Pfizer Inc. September 29, 2021. Accessed September 30, 2021. https://www.businesswire.com/news/home/20210929005276/en/Positive-Top-line-Results-of-Pfizer%E2%80%99s-Phase-3-Study-Exploring-Coadministration-of-Prevnar-20%E2%84%A2-With-Seasonal-Flu-Vaccine-in-Older-Adults-Released.