ong term immunogenicity of BNT162b2 vaccination and attitudes toward COVID-19 booster vaccines in Thai childre

Completed

• Conditions: immunogenecity of SARS-CoV-2 mRNA vaccine, vaccine hesitancy; SARS-CoV-2, mRNA vaccine, booster vaccination, Immunogenicity, immune waning, vaccine hesitancy

• Registration Number: TCTR20220301002
• Lead Sponsor: Ratchadapisek Research Funds

Brief Summary

A booster dose of BNT162b2 elicits high immunogenicity against the Omicron variant. Motivation for receiving booster doses is to reduce risk of infection

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Study Completion: 2022-04-09
• Results First Posted: 2022-07-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Participants must age 5 to <18 years old on the day of first dose vaccination, 2. Participants must be completed second dose of BNT162b2 vaccine for 6 months at the time of data collection, 3.Participants must be in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator, 4.Participants and parent(s) must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements, 5.Participants and/or parent(s) or legally authorized representative(s) must sign a written informed consent form, including any required privacy authorization form, prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements

Exclusion Criteria

1. Participants with previous documented SARS-CoV-2 infection, 2. Receipt of immunoglobulins or blood products between the day of first vaccination and blood collection, 3.Receipt of any other vaccines within 14 days (for inactivated vaccines except influenza vaccine) or 28 days (for lived vaccines) prior to blood collection, 4. Use of any medications that may be associated with impaired immune responsiveness or with immunosuppression.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-S-RBD IgG completed second dose of BNT162b2 vaccine for 6 months at the time of data collection BIOTEC COVID-19 IgG ELISA,Surrogate virus neutralization test (sVNT) to variants of concern completed second dose of BNT162b2 vaccine for 6 months at the time of data collection ELISA

Secondary Outcome Measures

Name	Time	Method
Vaccine hesitancy completed second dose of BNT162b2 vaccine for 6 months at the time of data collection Questionnaire