drugset / Trial / NCT03848065
Safety, Tolerability, and Immunogenicity of V114 in Healthy Japanese Infants (V114-028)
RandomizedParallel-groupTriple-blindPrevention
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 administered subcutaneously or intramuscularly in healthy Japanese infants (3 months of age).
Timeline
- Start
- 2019-04-02
- Primary completion
- 2020-06-24
- Completion
- 2020-06-24
Publications
- Results Ishihara Y, Kuroki H, Hidaka H, Iwai K, Wan K, Shirakawa M, Sawata M. Safety and immunogenicity of a 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A Phase I study (V114-028). Hum Vaccin Immunother. 2023 Dec 31;19(1):2180973. doi: 10.1080/21645515.2023.2180973. Epub 2023 Mar 7.
- Results Wan K, Shirakawa M, Sawata M. Descriptive analysis of safety and immunogenicity profiles of a 15-valent pneumococcal conjugate vaccine between subcutaneous and intramuscular administration in a phase 1 study of healthy Japanese infants (V114-028). J Infect Chemother. 2025 Feb;31(2):102539. doi: 10.1016/j.jiac.2024.10.007. Epub 2024 Oct 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTaP-IPV | Vaccine | 0.5 ml | Subcutaneous |
| Comparator | Prevnar 13 | Vaccine | 0.5 ml | Subcutaneous |
| Subject | V114 | Vaccine | 0.5 ml | Subcutaneous |