Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)

Summary

The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™. The primary hypotheses are that 1) V114 is noninferior to Prevnar 13™ as measured by the serotype specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for 13 shared serotypes at 30 days postvaccination and that 2) V114 is superior to Prevnar 13™ as measured by serotype-specific OPA GMTs for 2 unique serotypes in V114 at 30 days postvaccination.

Timeline

Start

2019-06-13

Primary completion

2020-03-30

Completion

2020-03-30

Outcome

Met primary endpoint

paper V114 met noninferiority criteria compared to PCV13 for the 13 shared serotypes PMID 34507861 ↗

paper and met superiority for the 2 unique serotypes PMID 34507861 ↗

release “In PNEU-AGE (V114-019), V114 Demonstrated Non-inferiority to the Currently Available 13-valent Pneumococcal Conjugate Vaccine for Shared Serotypes” merck.com ↗

Publications

• Platt HL, Cardona JF, Haranaka M, Schwartz HI, Narejos Perez S, Dowell A, Chang CJ, Dagan R, Tamms GM, Sterling T, Morgan L, Shi Y, Pedley A, Musey LK, Buchwald UK. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE). Vaccine. 2022 Jan 3;40(1):162-172. doi: 10.1016/j.vaccine.2021.08.049. Epub 2021 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Prevnar 13	Vaccine	0.5 ml	Intramuscular
Subject	V114	Vaccine	0.5 ml	Intramuscular

Indications