Trials / Completed
CompletedNCT06210737
A Study to Evaluate Persistence of Immunity of PCV13 in Healthy Population Aged 2 Months，7 Months-5 Years
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 621 (actual)
- Sponsor
- Beijing Minhai Biotechnology Co., Ltd · Industry
- Sex
- All
- Age
- 2 Months – 5 Years
- Healthy volunteers
- Accepted
Summary
The goal of this clinical trial is to learn about persistence of immunity of PCV13 in healthy population aged 2 months, 7 months-5 years. The main questions it aims to answer are the percentage of subjects reached the IgG level of ≥0.35 µg/mL, GMCs level for IgG antibody, and SAEs from one month to 12 months after the last injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PCV13 | 3 doses of PCV13 intramuscularly at Months 0, 2, and 4 and a booster dose at Month 10 |
| BIOLOGICAL | PCV13 | 2 doses of PCV13, and a booster dose |
| BIOLOGICAL | PCV13 | 2 doses of PCV13 |
| BIOLOGICAL | PCV13 | single dose of PCV13 |
Timeline
- Start date
- 2019-09-26
- Primary completion
- 2022-11-13
- Completion
- 2022-11-13
- First posted
- 2024-01-18
- Last updated
- 2024-01-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06210737. Inclusion in this directory is not an endorsement.