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RECRUITING
NCT06608199
PHASE3

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

Sponsor: Beijing Minhai Biotechnology Co., Ltd

View on ClinicalTrials.gov

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).

Official title: A Multi-center, Randomized, Blinded, Active-controlled, Phase 3 Clinical Study to Evaluate the Immunogenicity and Safety of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine Co-administered with Hexavalent Vaccine At 2, 4 and 12-15 Months of Age to Healthy Infants in Indonesia

Key Details

Gender

All

Age Range

6 Weeks - 8 Weeks

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-11-01

Completion Date

2026-10-01

Last Updated

2025-03-24

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

pneumococcal disease prevention

2P+1 programme of PCV13

Locations (3)

Faculty of Medicine Udayana University

Denpasar, Bali, Indonesia

Universitas Padjadjaran Bandung

Bandung, Bandung, Indonesia

Faculty of Medicine, padjadjaran University

Bandung, Bandung, Indonesia