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drugset / Trial / NCT06678620

Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT06678620 ↗

Phase 2 Active not recruiting 992 enrolled Shanghai Reinovax Biologics Co.,LTD
RandomizedParallel-groupQuadruple-blindPrevention

Summary

A phase II clinical trial of a 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older. The study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.

Timeline

Start
2024-04-20
Primary completion
2025-04-21
Completion
2026-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pneumovax 23 Vaccine 0.5 ml Intramuscular
Subject Reinovax PCV24 formulation 1 Vaccine 0.5 ml Intramuscular
Subject Reinovax PCV24 formulation 2 Vaccine 0.5 ml Intramuscular
Subject Reinovax PCV24 formulation 3 Vaccine 0.5 ml Intramuscular

Indications

pneumococcal infection