The immune response the BBIBP-CorV COVID-19 vaccine in adolescent in Thai population. COVID-19 vaccine, Sinopharm, adolescent, safety, immunogenicity
Conditions
Interventions
BBIBP CorV vaccine 0.5 ml intramuscular for 2 dose with 21 day (+7) interval.,BBIBP CorV vaccine 0.5 ml intramuscular for 2 dose with 21 day (+7) interval.
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
BBIBP in adolescents group,BBIBP in adult group
Sponsors
Chulabhorn Royal Academy
Eligibility
Sex/Gender
All
Age
12 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. age 12-30 year old 2. no active underlying disease. 3. informed to participated the study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety profile within 30 days after vaccination at day1, day7, and day30 Adverse events questionare | — |
Countries
Thailand
Contacts
Public ContactKriangkrai Tawinprai
HRH Princess Chulabhorn College of Medical Science
Outcome results
None listed