Immunogenicity and Reactogenicity of Fractional, Heterologous Primary COVID-19 Vaccination Schedules with BNT162b2 Boosters in 5-11-year-old Thai Children: A Multicenter, Prospective, Double-blind, Randomized Control Trial
- Conditions
- Healthy Thai Children and AdolescentsImmune Response Against SAR-CoV-2 Variants, Adverse Events, COVID-19 Vaccination, Children and Adolescent
- Registration Number
- TCTR20220406002
- Lead Sponsor
- Program Management Unit for Competitiveness (PMUC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 800
Males or females 5 - < 16 years of age (inclusive)
Never received any COVID-19 vaccine
Participant or guardian of participant understand(s) Thai language through speaking, reading and writing
Participant or guardian of participant be able to communicate through electronic tools such as Google form or line.
Capable of attending all study visits according to the study schedule.
Capable of informed assent/consent and provision of written informed consent before any study procedures
Have history of severe drug or vaccine allergy (anaphylaxis)?
Have ever detected COVID-19 infection?
Have history of COVID-19 high risk contact?
Did not receive any vaccine within 14 days before the enrollment?
Have received blood transfusion, plasma, blood product, blood component, immunoglobulins, antiviral or antibodies within the last 90 days?
Being pregnant?
Have unstable disease or could not control the symptom?
Have history of immunodeficiency or been using immunosuppressant or steroid drugs?
Had any of these chronic respiratory tract disease, cardiovascular disease, chronic kidney disease, diabetes, delayed development, and severe neurological conditions?
Have any unusual symptoms or medical history that considered unable to participate in the study?
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events within 7 days after vaccination and upto 12 weeks after 2nd dose Proportion of adverse events
- Secondary Outcome Measures
Name Time Method Immunological response 2 and 12 weeks after 2nd dose of vaccination RBD IgG level,Immunological response 2 weeks after 2nd dose of vaccination T cell response and NT