Antibody responses to mRNA COVID-19 vaccine (BNT162b2) in Thai children aged 5-11 years who were previously infected with SARS-CoV-2.

Phase 4

Completed

• Conditions: Healthy Thai children aged 5-11 years who were previously infected with SARS-CoV-2; children, previous infection, SARS-CoV-2, COVID-19, vaccines, mRNA vaccines, Adverse events, Vaccine safety

• Registration Number: TCTR20230123005
• Lead Sponsor: The National Vaccine Institute (NVI), Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-11-12
• Study Start: 2023-01-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

1. The subject is aged 5 to less than 12 years. 2. Previously infected with SARS-CoV-2 (confirmed by PCR or ATK test result) at least one month from onset or had positive result 3. Have not received any covid vaccines 4. Can understand Thai language through speaking, reading, and writing 5. 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 received any other vaccines within 14 days for live vaccines or 28 days for inactivated vaccines (excepted influenza vaccine) 3. Have body temperature more than equal 38 C or 100.4 F within 24 hours prior received study vaccine 4. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral, or antibodies within the last 90 days 5. Have any history of immunodeficiency or received immunosuppressants or received steroids drugs 6. 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 after vaccination Chemiluminescent microparticle immunoassay (CMIA) ,Cell-mediated immune responses 2-4 weeks after vaccination ELISpot assays, Neutralizing antibody 2-4 weeks after vaccination Neutralizing Antibody Assays

Secondary Outcome Measures

Name	Time	Method
Adverse event 7 days after vaccination Observe local and systemic reactions.