Immunogenicity to SARS-CoV-2 Omicron variant among school-aged children with 2-dose of inactivated SARS-CoV-2 vaccines followed by BNT162b2 booster
- Conditions
- 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
- Registration Number
- TCTR20220330001
- Lead Sponsor
- ational Vaccine Institute
- Brief Summary
A regimen of 2-dose of inactivated vaccine followed by BNT162b2 booster dose elicited high neutralizing antibody against the Omicron variants in healthy school-aged children.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surrogate neutralizing antibody at 14 days after booster vaccination Surrogate neutralizing antibody
- Secondary Outcome Measures
Name Time Method 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