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 Interventional Study
Pneumococcal Vaccines Pneumococcal Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
6 Weeks – 8 Weeks
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
500 (estimated)
Sponsor
Beijing Minhai Biotechnology Co., Ltd · Industry
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About This Trial
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 th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Healthy infants based on medical history and clinical assessment. 2. Infants age of 6-8 weeks at enrolment. Infants will be eligible since the day they reach 6 weeks of age and until 8 weeks of age included. 3. \*Body weight at enrollment ≥3.0 kg (If the subject does not meet…
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