Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) in Healthy Infants

Summary

This study will examine the consistency of 3 batches of the Pneumosil vaccine by looking at the immune response in infants. In addition, the study will compare the immunogenicity of the Pneumosil vaccine to another WHO-prequalified vaccine, Synflorix.

Timeline

Start

2017-06-21

Primary completion

2018-06-06

Completion

2019-05-09

Outcome

Met primary endpoint

paper Lot-to-lot equivalence was shown PMID 33516293 ↗

paper SIIPL-PCV was non-inferior to PHiD-CV in terms of immunogenicity: PMID 33516293 ↗

paper Non-inferiority of immune responses to the EPI vaccines after co-administration with SIIPL-PCV compared with after co-administration with PHiD-CV was shown PMID 33516293 ↗

Publications

• Clarke E, Bashorun A, Adigweme I, Badjie Hydara M, Umesi A, Futa A, Ochoge M, Obayemi D, Edem B, Saidy-Jah E, Onwuchekwa C, Dhere R, Sethna V, Kampmann B, Goldblatt D, Taylor D, Andi-Lolo I, Hosken N, Antony K, Innis BL, Alderson MR, Lamola S. Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Infect Dis. 2021 Jun;21(6):834-846. doi: 10.1016/S1473-3099(20)30735-0. Epub 2021 Jan 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pneumosil	Vaccine	0.5 ml	Intramuscular
Comparator	Synflorix	Vaccine	0.5 ml	Intramuscular

Indications