A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older.

Tosin Omole¹, Aaron S Weinberg², Masoud Azizad³, David Greenberg⁴, Carlos G Grijalva⁵, Walter A Orenstein⁶, Danielle Euler⁷, Doreen Fernsler⁷, Jun Park⁷, Jianing Li⁷, Heather L Platt⁷,

¹Merck & Co., Inc., Rahway, NJ, USA. Electronic address: tosin.omole@merck.com.

²Carbon Health, North, Hollywood, CA, USA.

³Valley Clinical Trials, Northridge, CA, USA.

⁴Soroka University Medical Center, Beer-Sheva, Israel.

⁵Vanderbilt University Medical Center, Nashville, TN, USA.

⁶Emory University, Atlanta, GA, USA.

⁷Merck & Co., Inc., Rahway, NJ, USA.

PubMed DOI

Abstract

BACKGROUND: Disease caused by Streptococcus pneumoniae is associated with considerable morbidity and mortality in adults. V116 is an approved 21-valent pneumococcal conjugate vaccine with a serotype composition designed to address the majority of residual pneumococcal disease in adults. This phase 3 study evaluated the safety, tolerability, and immunogenicity of V116 when administered concomitantl…

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Mentioned Companies

Carbon Health
affiliation

MeSH Terms

Humans0Influenza Vaccines*Male0Female0Middle Aged0Double-Blind Method0Aged0Pneumococcal Vaccines*Antibodies, Bacterial0Influenza, Human*Immunoglobulin G0Immunogenicity, Vaccine*Hemagglutination Inhibition Tests0Pneumococcal Infections*Aged, 80 and over0Streptococcus pneumoniae0Antibodies, Viral0Vaccines, Conjugate0

Keywords

ImmunogenicityInfluenza vaccinePneumococcal conjugate vaccineSafetyV116

Article Info

PMID: 40714528
DOI: 10.1016/j.vaccine.2025.127514
Received: September 13, 2024
Accepted: July 11, 2025

How to Cite

Omole T et al. A phase 3 randomized, double-blind clinical study to evaluate the safety and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. Vaccine2025;62127514. doi:10.1016/j.vaccine.2025.127514

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