drugset / Trial / NCT06675032
Phase I Clinical Trial of PCV24 in Children Aged 2 Months (Minimum 6 Weeks) to 17 Years
Phase 1
Active not recruiting
230 enrolled
Shanghai Reinovax Biologics Co.,LTD
Shaanxi Provincial Center for Disease Control and Prevention · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in children aged 2 Months (Minimum 6 Weeks) to 17 Years . The objective of the study is to evaluate the safety tolerability and immunogenicity of PCV24. The trial is a randomized, blind, controlled combined placebo and positive vaccine control I clinical trial.
Timeline
- Start
- 2024-04-27
- Primary completion
- 2025-05-10
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PCV24 formulation 1 | Vaccine | 0.5 ml | — |
| Subject | PCV24 formulation 2 | Vaccine | 0.5 ml | — |
| Subject | Prevnar 13 | Vaccine | 0.5 ml | — |