The immunogenicity and safety of BNT162b2 as a booster dose following fully immunized with inactivated vaccine in Thai children aged 5-11 years. SARS-CoV-2, Inactivated SARS-CoV-2 vaccine, BNT162b2, Children, Booster
Conditions
Interventions
BNT162b2 vaccine 10micrograms/0.2mL intramuscular injection
Experimental Biological/Vaccine
BNT162b2
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 must be completed 2-dose of inactivated Covid-19 vaccine (CoronavacTM/CoviloTM) 4-24 weeks 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 or caregivers 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 by history obtained from participant(s) or parent(s). 3. Receipt of immunoglobulins or blood products within 3 months of vaccination. 4. Receipt of any other vaccines within 14 days (for inactivated vaccines, not include 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. Presence of any acute illness required medical attention within 14 days of vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Surrogate neutralizing antibody at 14 days after booster vaccination Surrogate neutralizing antibody | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-spike-receptor binding domain antibody at 14 days after booster vaccination Anti-S-RBD,pseudovirus neutralizing antibody at 14, 90, 180 days after booster vaccination pseudovirus neutralizing antibody,Geometric means of antibody at 90 and 180 days after booster vaccination GMs of sVNT and anti-S-RBD IgG,Safety after booster vaccination Diary record | — |
Countries
Thailand
Contacts
Public ContactThanyawee Puthanakit
Faculty of Medicine, Chulalongkorn University
Outcome results
None listed