Clinical Trial

A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine

Recruiting Phase 3
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Record status
This record was last updated March 24, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine (PCV13) when co-administered with Hexavalent 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-DT/TT (Pneuminvac) as compared to PCV13(Prevenar 13) one month after the booster dose, and evaluate the safety of PCV13 co-administrated with Hexavalent Vaccine(Hexaxim).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-19.
Status change: Not Yet Recruiting → Recruiting 2025-03-20
Trial Details
NCT Number NCT06608199
Lead Sponsor Beijing Minhai Biotechnology Co., Ltd
Conditions Pneumococcal Vaccines, Pneumococcal Infections
Enrollment 500 participants
Start Date 2024-11-01
Primary Completion 2025-06-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-24