BNT162b2 in Thai childre
Phase 3
- Conditions
- Immunization to prevent COVID-19 infection.COVID-19, vaccination, BNT162b2, children, liver transplant, immunogenicity, safety
- Registration Number
- TCTR20220708003
- Lead Sponsor
- Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- nknown
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Children aged 5-12 years who underwent liver transplant for more than 6 months, clinical stable condition, no history of COVID-19 infection, no history of drug or vaccine allergy.
Exclusion Criteria
Unstable condition, fever, abnormal liver function test, no willing to participate in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety at d1-7 after dose 1 and 2 Adverse effect
- Secondary Outcome Measures
Name Time Method IgG to receptor binding protein At 5 time points (day0, wk5, wk8, wk16, wk28) U/mL,IgG to nucleocapsit antigen wk 5 %,Neutralizing antibody wk8, wk28 %,IFN-gamma Day0, wk3, wk5, wk16 SFU/10 million PBMCs