COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210917004

Assoc. Prof. Thanyawee Puthanakit

thanyawee.p@chula.ac.th

2021-09-17

Recruiting

RCT

Randomized

Parallel

Blind label

multi-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

3

National Vaccine Institute

12

18

Thailand

Healthy volunteers

N/A

120

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

Phase 2

[{"arm_notes": "30 ug;2;Days0-21", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "30 ug followed by 20 ug;2;Days0-21", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20 ug;2;Days0-21", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]