SARS-CoV-2 antibody response after a booster dose of the mRNA COVID-19 vaccine (BNT162b2) among Thai children and adolescents aged 5-17 years.
- Conditions
- Healthy Thai children aged 5-17 years who received two doses of the mRNA vaccine (BNT162b2).children, Booster dose, Third vaccination, SARS-CoV-2, COVID-19, vaccines, mRNA vaccines, Adverse events, Vaccine safety
- Registration Number
- TCTR20230424002
- Lead Sponsor
- Siriraj Grant for Research Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
1. The subject is aged 5 to less than 18 years. 2. Have received two doses of full dose mRNA COVID-19 vaccine 3. Have received 2nd dose of COVID-19 vaccine for at least 3 months at the time of third vaccination 4. Have no history of detecting SARS-CoV-2 infection 5. Can understand Thai language through speaking, reading, and writing 6. Capable of attending all study visits according to the study schedule
1. Have any history of severe drug or vaccine allergy (anaphylaxis) 2. Have a history of Myocarditis or pericarditis from the mRNA COVID-19 vaccine 3. Have received any other vaccines within 14 days for live vaccines or 28 days for inactivated vaccines (excepted influenza vaccine) 4. Have body temperature more than equal 38 C or 100.4 F within 24 hours prior received study vaccine 5. Subject who are pregnant 6. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral, or antibodies within the last 90 days 7. Have any history of immunodeficiency or received immunosuppressants or received steroids drugs 8. Have any conditions that are considered unsuitable for clinical study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-spike RBD antibody 2-4 weeks and 16-20 weeks after vaccination Chemiluminescent microparticle immunoassay (CMIA)
- Secondary Outcome Measures
Name Time Method eutralizing antibody 2-4 weeks after vaccination Neutralizing Antibody Assays,Adverse event 7 days after vaccination Observe local and systemic reactions.