COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20220406002

Orasri Wittawatmongkol

orasriw@hotmail.com

2022-04-06

Recruiting

RCT

Randomized

Sequential assignment

Open label

multi-center

Prevention

Males or females 5 - &lt, 16 years of age (inclusive) Never received any COVID-19 vaccine Participant or guardian of participant understand(s) Thai language through speaking, reading and writing Participant or guardian of participant be able to communicate through electronic tools such as Google form or line. Capable of attending all study visits according to the study schedule. Capable of informed assent/consent and provision of written informed consent before any study procedures

Have history of severe drug or vaccine allergy Yes (anaphylaxis)? Have ever detected COVID-19 infection? Have history of COVID-19 high risk contact? Did not receive any vaccine within 14 days before the enrollment? Have received blood transfusion, plasma, blood product, blood component, immunoglobulins, antiviral or antibodies within the last 90 days? Being pregnant? Have unstable disease or could not control the symptom? Have history of immunodeficiency or been using immunosuppressant or steroid drugs? Had any of these chronic respiratory tract disease, cardiovascular disease, chronic kidney disease, diabetes, delayed development, and severe neurological conditions? Have any unusual symptoms or medical history that considered unable to participate in the study?

4

Program Management Unit for Competitiveness (PMUC)

5

16

Thailand

Healthy volunteers

N/A

800

Adverse events within 7 days after vaccination and upto 12 weeks after 2nd dose Proportion of adverse events

Phase 1/Phase 2

[{"arm_notes": "full dose, previous CoronaVac", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose, previous CoronaVac", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "full dose, previous BNT162b2 (full dose)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "half dose, previous BNT162b2 (half dose)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]