Prevention of COVID-19 with SARS-CoV-2 mRNA vaccine platform, comparing standard and prolong interval, in healthy Thai children SARS-CoV-2, mRNA vaccine, COVID-19 vaccine, Children, Immunogenicity, Reactogenicity
Conditions
Interventions
- BNT162b2 10 ug/BNT162b2 10 ug, 21 days apart,- BNT162b2 10 ug/BNT162b2 10 ug, 56 days apart,- BNT162b2 10 ug booster (dose 3) at 90 days after the 2nd dose.
BNT162b2,BNT162b2,BNT162b2 booster
Sponsors
National Vaccine Institute
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Participants must age 5 to <12 years old. 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, physical examination (including vital signs), and the clinical judgment of the investigator. 4. Participants 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. Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs. 2. Participants with previous documented SARS-CoV-2 infection within 6 months of first vaccination. 3. Receipt of immunoglobulins or blood products within 3 months of first vaccination. 4. Receipt of any other vaccines within 14 days (for inactivated vaccines, except Influenza vaccine) or 28 days (for live vaccines) prior to enrollment in this trial. 5. 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. 6. Presence of any acute illness required medical attention within 14 days of first vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-S-RBD IgG day 0, before 2nd dose, 14 days, 90 days, and 180 days after 2nd dose BIOTEC COVID-19 IgG ELISA,Surrogate virus neutralization test (sVNT) to variants of concern day 0, before 2nd dose, 14 days, 90 days, 180 days after 2nd dose, and 14 days after 3rd dose ELISA,Pseudovirus neutralization test (pVNT) to variants of concern 14 days after 2nd and 3rd dose ELISA | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety After 1st dose, 14 days, 90 days, and 180 days after 2nd dose Solicited local and systemic adverse events, Unsolicited adverse events | — |
Countries
Thailand
Contacts
Public ContactProf. Thanyawee Puthanakit
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed