immunogenecity of SARS-CoV-2 mRNA vaccine, vaccine hesitancy SARS-CoV-2, mRNA vaccine, booster vaccination, Immunogenicity, immune waning, vaccine hesitancy
Conditions
Interventions
children aged 5-11 years completed second dose of BNT162b2 vaccine for 6 months at the time of data collection,adolescents aged 12-18 years completed second dose of BNT162b2 vaccine for 6 months at th
Prevention,Prevention
children aged 5-11 years,adolescents aged 12-18 years
Sponsors
Ratchadapisek Research Funds
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Vaccine hesitancy completed second dose of BNT162b2 vaccine for 6 months at the time of data collection Questionnaire | — |
Countries
Thailand
Contacts
Public ContactPavinee Assavavongwaikit
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed