Immunogenicity of 2 dose regimen of BNT162b2 mRNA vaccine in Thai children aged 6 months to 4 years following COVID 19 (COVID-19)

• Conditions: Prevention of COVID-19 with 2-dose mRNA vaccine among healthy Children 6 month to 4 years who had COVID-19 infection; SARS-CoV-2, mRNA vaccine, Infant, Children, Immunogenicity, Reactogenicity

• Registration Number: TCTR20221018008
• Lead Sponsor: Ratchadaphisek Sompoch Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Study Completion: 2023-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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.
Group A: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. (Documented by Antigen detection test or PCR at SARS-CoV-2 during July1, 2021 to November30, 2021)
Group B: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. (Documented by Antigen detection test or PCR at SARS-CoV-2 during February1, 2022 to December31, 2022 (the Omicron predominant Period)
(Note*: exclude Time overlapping between the Delta and the Omicron predominant periods is during December, 2021 to January, 2022)

Exclusion Criteria

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: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
immunogenicity 1 months after 2 dose regimen mRNA vaccine Geometric mean titer

Secondary Outcome Measures

Name	Time	Method
safety 1 month after 2dose regimen percent