Safety and Immunogenicity of SARS-CoV-2 mRNA vaccine platform in Thai children aged 5-11 years
- Conditions
- Prevention of COVID-19 with SARS-CoV-2 mRNA vaccine platform, comparing standard and prolong interval, in healthy Thai childrenSARS-CoV-2, mRNA vaccine, COVID-19 vaccine, Children, Immunogenicity, Reactogenicity
- Registration Number
- TCTR20220125002
- Lead Sponsor
- ational Vaccine Institute
- Brief Summary
In conclusion, an extended 8-week interval regimen of BNT162b2 induced higher neutralizing antibodies than a standard 3-week interval regimen. The booster dose induced high neutralizing antibodies against the Omicron variant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 344
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety After 1st dose, 14 days, 90 days, and 180 days after 2nd dose Solicited local and systemic adverse events, Unsolicited adverse events