COVID-19 trials registries data warehouse

https://www.thaiclinicaltrials.org/show/TCTR20210720002

Nasikarn Angkasekwinai

nasikarn.ang@mahidol.ac.th

2021-07-20

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

1. Males or females at least 18 years of age (inclusive) 2. Be subject of study Seroprevalence, Incidence and Immunological Responses to SARS-CoV-2 Infection among Frontline Healthcare Workers compare with Non-COVID-19 HCWs during the COVID-19 Pandemic at Siriraj Hospital, Bangkok or healthcare workers who interested in receiving the vaccine in the study 3. Capable of informed consent and provision of written informed consent before any study procedures

1. Could not receive vaccine such as history of anaphylaxis or severe infection with high temperature (over 38C) 2. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies for treatment of COVID-19 within the last 90 days - Have detected COVID-19 infection within the last 10 days 3. Have unstable disease or could not control the symptom such as chest pain, dyspnea, palpitation, etc. 4. Be pregnant 5. Have history of immunodeficiency or use immunosuppressant

2

Faculty of Medicine Siriraj Hospital

18

100

Thailand

Health workers

N/A

360

Adverse events 48 week Proportion of participant with adverse events within 7 days after vaccination

Phase 2/Phase 3

[{"arm_notes": "2", "treatment_id": 1972, "treatment_name": "Viral vector covid-19 vaccine", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2", "treatment_id": 643, "treatment_name": "Inactivated covid-19 vaccine", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]