Journal Article

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

Weinberg, Aaron S., Platt, Heather L., Orenstein, Walter A., Li, Jianing, Azizad, Masoud, Greenberg, David, Grijalva, Carlos G., Park, Jun, Fernsler, Doreen, Euler, Danielle, Omole, Tosin

2025

Overview

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 concomitantly with quadrivalent influenza vaccine (QIV) in adults. A total of 1080 healthy adults ≥ 50 years of age were randomized 1:1 to receive QIV and V116 concomitantly (n = 540) or QIV followed by V116 30 days later (n = 540). Immunogenicity was evaluated at 30 days postvaccination using opsonophagocytic activity (OPA) geometric mean titers (GMTs) and immunoglobulin G (IgG) geometric mean concentrations (GMCs) for V116, and hemagglutination inhibition (HAI) GMTs for QIV. For V116, the statistical criterion for noninferiority between groups required the lower bound of the 2-sided 95 % confidence interval of the OPA GMT ratio (concomitant/sequential groups) to be > 0.5. For QIV, the statistical criterion for noninferiority required the lower bound of the 2-sided 95 % CI of the HAI GMT ratio (concomitant/sequential groups) to be >0.67. Safety was evaluated by the proportion of participants with adverse events (AEs). The concomitant group met the primary noninferiority immunogenicity endpoints for 20 of 21 serotypes in V116 and for 3 of 4 influenza strains in QIV; noninferiority criteria were narrowly missed for serotype 23B and influenza H3N2. IgG GMCs at 30 days postvaccination were generally comparable between groups for all V116 serotypes. The proportions of participants with injection-site, systemic, vaccine-related, and serious AEs were generally comparable between groups. In adults ≥ 50 years of age, V116 is well tolerated and immunogenic when given concomitantly with QIV. Study results support use of V116 with QIV.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Adults / Age / Aged / Aged, 80 and over / Allergy and Immunology / Antibodies / Antibodies, Bacterial - blood / Antibodies, Viral - blood / Chronic illnesses / Clinical trials / confidence interval / Criteria / Disease prevention / Double-Blind Method / Female / hemagglutination / Hemagglutination inhibition / Hemagglutination Inhibition Tests / Humans / IgG antibody / Immunization / Immunogenicity / Immunogenicity, Vaccine / Immunoglobulin G / Immunoglobulin G - blood / Influenza / Influenza vaccine / influenza vaccines / Influenza Vaccines - administration & dosage / Influenza Vaccines - adverse effects / Influenza Vaccines - immunology / Influenza, Human - prevention & control / injection site / Lower bounds / Male / Middle Aged / Morbidity / Mortality / Objectives / Pneumococcal conjugate vaccine / Pneumococcal Infections - prevention & control / Pneumococcal Vaccines - administration & dosage / Pneumococcal Vaccines - adverse effects / Pneumococcal Vaccines - immunology / Pneumonia / Ratios / Safety / Serotypes / Statistical analysis / Statistical methods / Statistics / Streptococcus infections / Streptococcus pneumoniae / Streptococcus pneumoniae - immunology / V116 / Vaccines / Vaccines, Conjugate - administration & dosage / Vaccines, Conjugate - adverse effects / Vaccines, Conjugate - immunology