drugset / Trial / NCT05759520

Phase III Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine (Multivalent Conjugate) in Infants

NCT05759520

Phase 3 Active not recruiting 1800 enrolled Fosun Adgenvax Biopharmaceutical Co.,Ltd.
RandomizedParallel-groupDouble-blindPrevention

Summary

This study is a phase III clinical trial to evaluate the immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (multivalent conjugate) in infants aged 2 months (at least 6 weeks) and 3 months. The main objectives of the study include: 1. To evaluate the immunogenicity of the trial vaccine in infants aged 2 months (at least 6 weeks) following the corresponding immunization schedule compared to the control vaccine; 2. To evaluate the immunogenicity of the trial vaccine in infants aged 3 months following the corresponding immunization schedule compared to the 2-month group; 3. To evaluate the safety of the trial vaccine in infants aged 2 months (at least 6 weeks) and 3 months following the corresponding immunization schedule.

Timeline

Start
2022-11-04
Primary completion
2025-06-30
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject 13-valent pneumococcal conjugate vaccine (multivalent conjugate) Vaccine
Comparator Prevnar 13 Vaccine