Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Summary

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

Timeline

Start

2022-07-13

Primary completion

2023-05-18

Completion

2023-05-18

Outcome

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

paper V116 met non-inferiority criteria compared with PCV20 for the ten serotypes common to both vaccines at day 30 in cohort 1 reads as mixed primary results PMID 38964361 ↗

paper V116 met superiority criteria compared with PCV20 in cohort 1 for ten of the 11 serotypes unique to V116 at day 30 reads as mixed primary results PMID 38964361 ↗

paper except 15C, which was p=0·41 reads as mixed primary results PMID 38964361 ↗

paper superior to PCV20 for all serotypes unique to V116, except for 15C. reads as mixed primary results PMID 38964361 ↗

release “Results from the STRIDE-3 trial demonstrated statistically significant immune responses compared to PCV20 (pneumococcal 20-valent conjugate vaccine) in vaccine-naïve adults” reads as met primary endpoint ligand.com ↗

release “STRIDE-3試験の結果から、V116は、ワクチン未接種の成人において、PCV20（20価肺炎球菌結合型ワクチン）を対照に、両ワクチンに共通の血清型に対して統計的に有意な免疫応答を示しました。” reads as met primary endpoint msd.co.jp ↗

Publications

• Results Platt HL, Bruno C, Buntinx E, Pelayo E, Garcia-Huidobro D, Barranco-Santana EA, Sjoberg F, Song JY, Grijalva CG, Orenstein WA, Morgan L, Fernsler D, Xu W, Waleed M, Li J, Buchwald UK; STRIDE-3 Study Group. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial. Lancet Infect Dis. 2024 Oct;24(10):1141-1150. doi: 10.1016/S1473-3099(24)00344-X. Epub 2024 Jul 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	PCV20	Vaccine	0.5 ml	Intramuscular
Subject	V116	Vaccine	0.5 ml	Intramuscular

Indications