NCT05602480

Phase I Clinical Trial of a Candidate PCV13 in Healthy People

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Wuhan BravoVax Co., Ltd. · Industry
• Sex: All
• Age: 6 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	0.5mL, Intramuscular
BIOLOGICAL	13-Valent Pneumococcal Polysaccharide Conjugate Vaccine	0.5mL, Intramuscular

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2022-11-02
• Last updated: 2022-11-17

Locations

1 site across 1 country: China