COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05003479

Guifan Li, M.S

liguifan@biominhai.com

2021-08-12

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: - healthy residents aged 3 to 17 years at the time of consent - subjects and/or their guardian agree to sign the informed consent forms voluntarily. - be able to comply with study requirements/procedures. - axillary temperature ≤ 37.0℃

- within 14 days before vaccination, subjects have been abroad and to villages/communities experienced covid-19 epidemics, and in contact with covid-19 cases or suspected cases. subjects are under isolation observation, or living in the villages/communities with covid-19 cases or suspected cases; - confirmed cases, suspected cases or asymptomatic cases with covid-19 (refer to information system of china disease prevention and control); - subjects with history of sars virus infection by self-reported; - positive in throat swab through rt-pcr; - history of vaccination of various covid-19 vaccines or positive in sars-cov-2 antibody test; - positive urine pregnancy test for females with menarche - with abnormal indicators, such as blood biochemistry, blood routine, urine routine, thyroid function and coagulation function which might show clinical meaning, before administration; - history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated sars-cov-2 vaccine; - history or family history of convulsion, epilepsy, encephalopathy or mental illness; - subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; - subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, drug-uncontrollable hypertension, diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; - diagnosed with congenital or acquired immunodeficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases; - history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease); - subjects receiving anti-tb treatment; - subjects receiving other research drugs within 6 months before vaccination; - subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); - subjects receiving blood products within 3 months before administration; - subjects vaccinated with live attenuated vaccine within 14 days before vaccination; - subjects vaccinated with other vaccine within 7 days before vaccination; - the researchers shall judge the other conditions which might be not in compliance with the requirements of this clinical trial.

2

Shenzhen Kangtai Biological Products Co., LTD

3

17

China

Healthy volunteers

N/A

84

Incidence of adverse reactions/events

None

Phase 1

[{"arm_notes": "", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]