Trials / Completed
CompletedNCT05477693
Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine
A Randomized, Double-blind, Positive-controlled Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of 23-valent Pneumococcal Polysaccharide Vaccine in Population Aged 2 Years and Older
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,800 (actual)
- Sponsor
- Sinovac Biotech Co., Ltd · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial of 23-valent pneumococcal polysaccharide vaccine manufactured by Sinovac Biotech Co., Ltd.The purpose of this study is to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.
Detailed description
This study is a randomized, double-blind, positive-controlled phase Ⅳ clinical trial to evaluate the immunogenicity and safety of 23-valent pneumococcal polysaccharide vaccine in population aged 2 years and older.The experimental vaccine was manufactured by Sinovac Biotech Co., Ltd,the control vaccine was manufactured by Merck Sharp \& Dohme.A total of 1800 subjects including 900 subjects aged 2\~17 years,360 subjects aged 18\~59 years and 540 subjects aged 60 years and above will be enrolled.Subjects in each age group will be randomly divided into two groups according to the ratio of 2:1, and received one dose of experimental vaccine or control vaccine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Experimental 23-valent PPV | The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B,17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0.5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection. |
| BIOLOGICAL | Control 23-valent PPV | The control vaccine was manufactured by Merck Sharp \& Dohme, Ltd. Purified capsular polysaccharides from 23 Streptococcus in 0.5 mL of pneumoniae types 0.25% phenol and sodium chloride. |
Timeline
- Start date
- 2022-10-25
- Primary completion
- 2023-04-10
- Completion
- 2023-04-10
- First posted
- 2022-07-28
- Last updated
- 2023-09-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05477693. Inclusion in this directory is not an endorsement.