TCTR20230424002CompletedPhase 4
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.
Siriraj Grant for Research Development0 sites150 target enrollmentStarted: April 24, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 5 Years to 17 Years (—)
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Investigators
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