COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210923012

Prof. Thanyawee Puthanakit

thanyawee.p@chula.ac.th

2021-09-23

Recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Participants must age 12 to &lt,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.

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

4

National Vaccine Institute

12

17

Thailand

Healthy volunteers

N/A

80

Anti-S-RBD IgG Day 0; day 21/42; day 35/56; day 90/120; day 180; day 194; day 360 BIOTEC COVID-19 IgG ELISA;Surrogate virus neutralization test (sVNT) to variants of concern e.g. Delta strain Day 0; day 21/42; day 35/56; day 90/120; day 180; day 194; day 360 ELISA;T and B cell response Day 35/56; day 90/120; day 180 ELISpot;Pseudovirus neutralizing antibody (pVNT) to Omicron strain Day 180; day 194; day 360 BIOTEC In-house assay

Phase 2

[{"arm_notes": "CoronaVac 0.5 ml - BNT162b2 30 ug 21 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "CoronaVac 0.5 ml - BNT162b2 20 ug 21 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "CoronaVac 0.5 ml - BNT162b2 30 ug 42 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "CoronaVac 0.5 ml - BNT162b2 20 ug 42 days apart", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with BNT162b2 10 ug (orange cap; 0.2 mL IM) at day 180", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with BNT162b2 15 ug (purple cap; 0.15 mL IM) at day 180", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Booster with BNT162b2 30 ug (purple cap; 0.3 mL IM) at day 180", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]