COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05365724

Lanjuan Li

Not reported

2022-05-09

Not recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: healthy subjects aged 18 years old and above. by asking for medical history and physical examination, the investigator judged - that the health condition 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 12 months after enrolment. effective contraceptive measures have been taken within 2 weeks before inclusion. during the whole follow-up period of the study, 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 clinical study protocol.

confirmed or suspected cases of sars-cov-2 infection. has a history of sars, mers, sars-cov-2 infection (self-report, on-site inquiry). has received covid-19 vaccine (include mrna, recombinant protein vaccines, vector vaccines, inactivated vaccines, etc.) axillary body temperature > 37.3 ℃ before vaccination 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 (self-report, on-site inquiry). history of hospital-diagnosed thrombocytopenia or other coagulation disorder known immunological impairment or low level with hospital diagnosis history of uncontrolled epilepsy, other progressive neurological disorders, or guillain-barre syndrome (self-report, on-site inquiry). known or suspected concomitant serious diseases include: respiratory disease, acute infection or active chronic disease, liver and kidney disease, severe diabetes, malignant tumor, infection or allergic skin disease, hiv infection. severe cardiovascular disease (cardiopulmonary failure, uncontrolled hypertension, etc.) diagnosed by the hospital, active chronic respiratory disease live attenuated vaccine is inoculated within 1 month before this vaccination other vaccines are inoculated within 14 days before this vaccination. be participating in or plan to participate in other vaccine clinical trials during this study. contraindications related to vaccination as considered by other investigators.

2

China National Biotec Group Company Limited

18

100

China

Healthy volunteers

N/A

280

Incidence of adverse reactions;The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2;The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2

None

Phase 1/Phase 2

[{"arm_notes": "subjects aged 18-59 years old", "treatment_id": 2485, "treatment_name": "Omicron covid-19 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "subjects aged 60 years old and above", "treatment_id": 2485, "treatment_name": "Omicron covid-19 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]