COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04863638

Yanxia Wang

Not reported

2021-04-28

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: - aged 3 years and above (after enrolled, subjects will be allocated according to age). - by asking for medical history and physical examination, the health condition judged by the investigators is well. - female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. effective contraceptive measures have been taken within 2 weeks before inclusion. - no vaccination history of covid-19 vaccine before enrollment. - be able and willing to complete the whole prescribed study plan. - with self-ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

- confirmed cases, suspected cases or asymptomatic infections of sar-cov-2 infection (check "china disease prevention and control information system"). - has a history of sars, mers infection (self-report, on-site inquiry). - >14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃. - previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated sars-cov-2 vaccine have occurred. - with severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmhg, diastolic blood pressure ≥100 mmhg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases. - has been diagnosed with congenital or acquired immune deficiency, hiv infection, lymphoma, leukemia or other autoimmune diseases. - has a history of convulsion, epilepsy, encephalopathy or mental illness or family history. - with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. - has a history of coagulation dysfunction (e.g. coagulation factor deficiency, coagulation disease). - received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days). - received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination. - received blood products within 3 months before enrolment. - received other research drugs within 6 months before enrolment. - other circumstances judged by investigators are not suitable for this clinical trial.

4

China National Biotec Group Company Limited

3

100

China

Healthy volunteers

N/A

4400

The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody;The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody

None

Phase 4

[{"arm_notes": "3;Days0-21-42;age \u2265 71 or 60-70 or 18-59 or 9-17 or 3-8", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3;Days0-21-111;age \u2265 71 or 60-70 or 18-59 or 9-17 or 3-8", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "3;Days0-21-171;age \u2265 71 or 60-70 or 18-59 or 9-17 or 3-8", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;days0-21;age 18-59 or 9-17 or 3-8", "treatment_id": 184, "treatment_name": "Bbibp-corv", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]