Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)

Summary

The primary objectives are to evaluate the safety and tolerability of V114 and to compare the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) across 3 different lots of V114. The primary hypothesis is that all 3 lots of V114 are equivalent as measured by the serotype-specific OPA GMTs for 15 serotypes in V114 at 30 days postvaccination.

Timeline

Start

2019-06-12

Primary completion

2020-04-03

Completion

2020-04-03

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper Comparison of V114 combined lots with PCV13 showed that proportions of participants experiencing AEs, solicited AEs, and serious AEs were comparable for both vaccines, with the exception of injection-site pain (more frequently reported with V114). reads as mixed primary results PMID 35039194 ↗

paper all lots met predefined equivalence criteria for all 15 vaccine serotypes reads as mixed primary results PMID 35039194 ↗

registry analysis (other test); V114 Combined Lots 1,2 and 3 vs Prevnar13™; p <0.001; Difference in Percentage 14.6 (95% CI 7.9 to 21.4); Miettinen & Nurminen reads as mixed primary results NCT03950856 ↗

release “PNEU-TRUE (V114-020), in healthy adults 50 years of age or older, V114 met its primary immunogenicity objective” reads as met primary endpoint merck.com ↗

Publications

• Simon JK, Staerke NB, Hemming-Harlo M, Layle S, Dagan R, Shekar T, Pedley A, Jumes P, Tamms G, Sterling T, Musey L, Buchwald UK; V114-020 PNEU-TRUE study group. Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged >/=50 years: A randomized phase 3 trial (PNEU-TRUE). Vaccine. 2022 Feb 23;40(9):1342-1351. doi: 10.1016/j.vaccine.2021.12.067. Epub 2022 Jan 14.

Drugs

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

Indications