drugset

drugset / Trial / NCT04530838

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

NCT04530838 ↗

Phase 3 Completed 668 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindPrevention

Summary

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Timeline

Start: 2020-09-16
Primary completion: 2022-04-02
Completion: 2022-04-02

Outcome

Mixed primary results

paper The primary noninferiority objective for PCV20 SC to PCV13 SC was met for 11/13 matched and 5/7 additional serotypes. PMID 38242195 ↗

Publications

Ishihara Y, Fukazawa M, Enomoto S, de Solom R, Yamaji M, Kline M, Aizawa M, Peng Y, Kogawara O, Giardina PC, Tamimi N, Gruber WC, Watson W. A phase 3 randomized study to evaluate safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in healthy Japanese infants. Int J Infect Dis. 2024 Apr;141:106942. doi: 10.1016/j.ijid.2024.01.009. Epub 2024 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	13-valent pneumococcal conjugate vaccine	Vaccine	—	Subcutaneous
Subject	20-valent pneumococcal conjugate vaccine	Vaccine	—	Subcutaneous

Indications