Immunogenicity and safety of the BBIBP-CorV COVID-19 vaccine in adolescent in Thailand
Phase 2
Recruiting
- Conditions
- The immune response the BBIBP-CorV COVID-19 vaccine in adolescent in Thai population.COVID-19 vaccine, Sinopharm, adolescent, safety, immunogenicity
- Registration Number
- TCTR20210920005
- Lead Sponsor
- Chulabhorn Royal Academy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. age 12-30 year old
2. no active underlying disease.
3. informed to participated the study.
Exclusion Criteria
1. previous infection with SAR-CoV-2
2. previous received SAR-CoV-2 vaccine
3. receive any vaccine with 14 days
4. Fever at vaccination day
5. History of URI within 14 days
6. History of seizure.
7. Abnormal development
8. Pregnancy.
9. Lactation.
10. History of severe allergy to vaccine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Geomatric mean ratio (GMR) of anti-RBD of SARS-CoV-2 between adolescent group and adult group 4 week after second shot Anti-RBD antibodies level
- Secondary Outcome Measures
Name Time Method Safety profile within 30 days after vaccination at day1, day7, and day30 Adverse events questionare