A Phase 3 Study to Evaluate the Immunogenicity and Safety of Walvax's PCV13-TT as Compared to Pfizer's PCV13

Summary

The goal of this clinical trial is to evaluate the immunogenicity and safety of a novel 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13-TT) as compared to Pfizer's 13-valent pneumococcal conjugate vaccine (PCV13) when co-administered with local EPI Vaccines at 2, 4, and 12-15 months of age, to healthy infants in Indonesia. This study aims to demonstrate the non-inferiority of the serotype-specific immune responses elicited by the novel PCV13-TT as compared to PCV13 one month after the booster dose.

Timeline

Start

2023-11-23

Primary completion

2025-03

Completion

2026-02

Drugs

Indications