Trials / Completed
CompletedNCT04700618
A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old
A Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 330 (actual)
- Sponsor
- China National Biotec Group Company Limited · Industry
- Sex
- All
- Age
- 60 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
Objective: To evaluate the safety and immunogenicity of PPV23 vaccine revaccinated in 60-70 years old in Shanghai.
Detailed description
1. Antibody double growth rate in 28-40 days after immunization; 2. Antibody GMC level in 28-40days after immunization; 3. Incidence of adverse reactions in 0-30days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | 23-valent pneumococcal polysaccharide vaccine | The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days. |
Timeline
- Start date
- 2021-03-21
- Primary completion
- 2021-08-22
- Completion
- 2022-02-13
- First posted
- 2021-01-08
- Last updated
- 2022-02-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04700618. Inclusion in this directory is not an endorsement.