Safety and Immunogenicity of mRNA SARS-CoV-2 vaccine in healthy Thai children aged 6 months-4 years with or without previous SARS-CoV-2 infection (COVID-19)
- Conditions
- Prevention of COVID-19 with SARS-CoV-2 mRNA vaccine platform, comparing the number of doses and interval after infection, in healthy Thai children aged 6 months to 4 years.SARS-CoV-2, mRNA vaccine, COVID-19 vaccine, Child, Infant, Immunogenicity, Reactogenicity
- Registration Number
- TCTR20220927003
- Lead Sponsor
- ational Vaccine Institute
- Brief Summary
Children previously infected with SARS-CoV-2 Omicron variant, developed robust neutralizing antibody response against Omicron variant after single-dose BNT162b2. Children with an interval of more than 6 months since COVID-19 infection developed higher neutralizing antibody response compared to those with a 3-to-6-month interval.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 106
1.Participants must age 6 months to <5 years old on the day of first dose vaccination.
2.Participants have never received vaccination against SARS-CoV-2 prior to study enrollment.
3.Participants must be in good health at the time of entry into the trial as determined by medical history, and the clinical judgment of the investigator.
4.Parent(s) or legally authorized representative(s) gave consent to participants in the trial.
5.Arm A and B: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. Documented by Antigen detection test or PCR of SARS-CoV-2 in year 2022 (Omicron predominant circulated)
Arm A: 3-6 months prior to enrollment date
Arm B: > 6 months prior to enrollment date
6.Control group (Arm C): Participants have no previous history SARS-CoV-2 infection obtained from parent(s) and/or negative anti-nucleocapsid antibody test at baseline prior to vaccination.
1.Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs.
2.Receipt of immunoglobulins or blood products within 3 months of first vaccination.
3.Use of or anticipated need to use, within the next 6 months of any medications that may be associated with impaired immune responsiveness or with immunosuppression.
4.Presence of any acute illness required medical attention within 14 days of first vaccination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pseudovirus neutralization test (pVNT) to variants of concern e.g., Omicron strain day 0, 28, 56, 112 ELISA
- Secondary Outcome Measures
Name Time Method Surrogate virus neutralization test (sVNT) to variants of concern e.g., Omicron strain day 0, 28, 56, 112 ELISA,Anti-S-RBD IgG day 0, 28, 56, 112 ELISA,Safety day 0, 28, 56, 84, 112 Solicited local and systemic adverse events, Unsolicited adverse events