COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210907003

Assoc. Prof. Somruedee Chatsiricharoenkul

somruedee.cha@mahidol.ac.th

2021-09-07

Not recruiting

RCT

Randomized

Sequential assignment

Open label

single-center

Prevention

1.Males or females at least 18 years of age (inclusive), 2. Have completed primary series of COVID-19 vaccines (2 doses of Sinovac, AstraZeneca, or mRNA) between 6-10 weeks?, 3. Can understand Thai language through speaking, reading and writing?, 4. Able to communicate through electronic tools such as Google form or line., 5. Capable of attending all study visits according to the study schedule., 6. Capable of informed consent and provision of written informed consent before any study procedures

1. Have history of severe drug or vaccine allergy (anaphylaxis)?, 2. Have ever been detected COVID-19 infection?, 3.Have any history of contacting COVID-19 patient (high risk contact)?, 4. Positive result of antigen test kit?, 5. Have received blood transfusion, plasma, blood product, blood component, immunoglobulins, antiviral or antibodies within the last 90 days?, 6.Have history of cigarettes smoking, alcohol drinking and history of drug abuse? , 7. Being pregnant?, 8. Have unstable disease or could not control the symptom?, 9. Have history of immunodeficiency or been using immunosuppressant or steroid drugs?, 10. Have any unusual symptoms or medical history that considered unable to participate in the study?

6

Faculty of Medicine Siriraj Hospital; Mahidol University

18

60

Thailand

Healthy volunteers

N/A

60

Safety at 7 days after vaccination adverse event

Phase 1/Phase 2

[{"arm_notes": "third dose;fully vaccinated first and second dose Inactivated vaccine", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose;fully vaccinated first and second dose Inactivated vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose;fully vaccinated first and second dose ChAdOx1 nCoV-19", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose;fully vaccinated first and second dose ChAdOx1 nCoV-19", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose;fully vaccinated first and second dose mRNA vaccine", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "third dose;fully vaccinated first and second dose mRNA vaccine", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]