drugset / Trial / NCT05602480
Phase I Clinical Trial of a Candidate PCV13 in Healthy People
Phase 1
Unknown
264 enrolled
Wuhan BravoVax Co., Ltd.
Hunan Provincial Center for Disease Control and Prevention · collabLiaoning Chengda Biotechnology CO., LTD · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year. Since the licensure of PCV7, PCV10, PCV13 and PCV15, the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years is approximately 60% around the world. This is a single center, blinded, randomized, positive-controlled phase I clinical trial to evaluate the safety and explore the immunogenicity of a candidate PCV13 in healthy people aged 2 months (minimum 6 weeks) and above.
Timeline
- Start
- 2022-11-01
- Primary completion
- 2024-06
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prevnar 13 | Vaccine | 0.5 ml | Intramuscular |