Trials / Active Not Recruiting
Active Not RecruitingNCT06678620
Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine
A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 992 (estimated)
- Sponsor
- Shanghai Reinovax Biologics Co.,LTD · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Phase II clinical trial of the 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 active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products. At least 992 participants will be enrolled, including 496 adults aged 18-60 and 496 elderly people aged ≥61. Participants will be randomized 1:1:1:1 to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PCV24 formulation 3,or PPSV23.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Reinovax PCV24 formulation 1 | One dose of Reinovax PCV24 formulation 1（0.5mL） |
| BIOLOGICAL | Reinovax PCV24 formulation 2 | One dose of Reinovax PCV24 formulation 1（0.5mL） |
| BIOLOGICAL | Reinovax PCV24 formulation 3 | One dose of Reinovax PCV24 formulation 1（0.5mL） |
| BIOLOGICAL | PPSV23 | One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides. |
Timeline
- Start date
- 2024-04-20
- Primary completion
- 2025-04-21
- Completion
- 2026-03-01
- First posted
- 2024-11-07
- Last updated
- 2025-12-17
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06678620. Inclusion in this directory is not an endorsement.