Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-033)

Summary

The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.

Timeline

Start

2020-07-01

Primary completion

2021-12-01

Completion

2021-12-01

Outcome

Mixed primary results

paper V114 met non-inferiority criteria for all 13shared serotypes, based on difference in proportion of responders PMID 37344262 ↗

paper The non-inferiority criterion based on IgG response rates was met for serotype 22F, but narrowly missed for serotype 33F PMID 37344262 ↗

Publications

• Results Suzuki H, Fujita H, Iwai K, Kuroki H, Taniyama K, Shizuya T, Kishino H, Igarashi R, Shirakawa M, Sawata M. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033). Vaccine. 2023 Jul 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	PCV13	Vaccine	0.5 ml	Subcutaneous
Subject	V114	Vaccine	0.5 ml	Subcutaneous

Indications