Prevention of COVID-19 with SARS CoV-2 mRNA vaccine platform, comparing standard dose and low dose, in healthy Thai adolescent SARS-CoV-2, mRNA vaccine, COVID-19 vaccine, Adolescent, Immunogenicity, Reactogenicity
Conditions
Interventions
- BNT162b2 30 ug
- BNT162b2 30 ug 21 days apart,- BNT162b2 30 ug
- BNT162b2 20 ug 21 days apart,- BNT162b2 20 ug
- BNT162b2 20 ug 21 days apart,Booster with BNT162b2 10 ug (orange cap
Active Comparator Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Active Comparator Biological/Vaccin
Standard dose BNT162b2 ,Standard/low dose BNT162b2,Low dose BNT162b2,10-ug BNT162b2 booster ,15-ug BNT162b2 booster ,30-ug BNT162b2 booster
Sponsors
National Vaccine Institute
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Participants must age 12 to <18 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) 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. Participants who are pregnant or breastfeeding. 7. Presence of any acute illness required medical attention within 14 days of first vaccination. 8. Participants with body mass index more than 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-S-RBD IgG Day 0, day 21, day 35, day 180, day 194, day 360 BIOTEC COVID-19 IgG ELISA,Surrogate virus neutralization test (sVNT) to Beta and Delta strain Day 0, day 21, day 35, day 180 ELISA,T and B cell response Day 0, day 35, day 180 ELISpot,Surrogate virus neutralization test (sVNT) to Delta and Omicron strain Day 180, day 194, day 360 ELISA,Pseudovirus neutralizing antibody (pVNT) to Omicron strain Day 180, day 194, day 360 BIOTEC In-house assay | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety 21 days, 35 days, 180 days, 194 days, 360 days Solicited local and systemic adverse events, Unsolicited adverse events | — |
Countries
Thailand
Contacts
Public ContactAssoc. Prof. Thanyawee Puthanakit
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed