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Clinical Trial
. 2025 Oct 10;6(10):100748.
doi: 10.1016/j.medj.2025.100748. Epub 2025 Jun 20.

A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4)

Paul Scott  1 , Benita Ukkonen  2 , Yoseph Caraco  3 , Silvia Narejos Perez  4 , Sady Armada Alpizar  5 , Jose Francisco Cardona  6 , David Greenberg  7 , Carlos G Grijalva  8 , Walter Orenstein  9 , Richard T Wiedmann  10 , Doreen Fernsler  10 , Kyeongmi Cheon  10 , Jianing Li  10 , Heather Loryn Platt  10
Affiliations
Clinical Trial

A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4)

Paul Scott et al. Med. .

Abstract

Background: Streptococcus pneumoniae infection can lead to community-acquired pneumonia and invasive pneumococcal disease (IPD), conditions associated with substantial morbidity and mortality. V116 (Merck & Co., Inc., Rahway, NJ, USA) is a 21-valent, adult-specific pneumococcal conjugate vaccine (PCV) indicated for protection against pneumonia and IPD caused by S. pneumoniae.

Methods: This global phase 3 trial (ClinicalTrials.gov: NCT05464420) evaluated the manufacturing consistency of V116. Adult participants were randomly assigned to receive a single dose of V116 from one of three lots or the 23-valent pneumococcal polysaccharide vaccine (PPSV23). Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) were assessed 30 days post-vaccination. Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and geometric mean fold rises for OPA and IgG responses were also evaluated. Solicited systemic and injection site adverse events (AEs) were collected for 5 days post-vaccination, serious AEs were reported throughout study participation, and all other AEs were reported for 30 days post-vaccination.

Findings: All three lots of V116 met equivalence criteria based on OPA GMTs for all 21 serotypes. OPA GMTs and IgG GMCs were comparable between the combined V116 lots and PPSV23 for shared serotypes and were higher in the combined V116 lots for serotypes unique to V116. AEs were similar across the three lots of V116 and between the combined V116 lots and PPSV23.

Conclusions: V116 exhibited immunogenicity and safety profiles that were consistent across three manufacturing lots.

Funding: Funding for this research was provided by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Keywords: 21-valent adult-specific pneumococcal conjugate vaccine; Translation to patients; V116; immunogenicity; lot-to-lot consistency; manufacturing consistency; pneumococcal vaccines; safety profile.

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Conflict of interest statement

Declaration of interests P.S., R.T.W., D.F., K.C., J.L., and H.L.P. are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (MSD), and may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. B.U. is an employee of Finnish Vaccine Research, which conducts vaccine-related research in collaboration with major vaccine manufacturers, including MSD, and has received travel support from Sanofi and Moderna. C.G.G. has served on advisory boards for MSD and GSK and has received research support from the CDC, the National Institutes of Health, the FDA, the Agency for Healthcare Research and Quality, and Syneos Health.

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