COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05293548

Not reported

yangyunkai@sinopharm.com (Yunkai Yang, Prof.)

2022-03-24

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: age: population aged 18 years and above; judged by the investigator that the health condition is well after inquiry and physical examination; vaccinated with 2 or 3 doses of inactivated covid-19 vaccine (vero cell vaccine) 6 months prior to study screening and according to product insert; female participants who are not pregnant or nursing or at the time of enrolment (confirmed via negative urine pregnancy test), and do not have plans to become pregnant within the first 6 months after enrollment. effective contraceptive measures have been taken within 2 weeks before study inclusion and initiation; be able and willing to provide written informed consent to participate in the study and complete all study requirements according to the study protocol;

covid-19 infection positive patients (including suspected or asymptomatic cases); have a history of sars and mers infection; have been vaccinated by any covid-19 vaccines other than vero cell vaccine； have an axillary temperature 37.3 (forehead temperature 37.8℃℃); have had previous allergic reactions to vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic oedema or abdominal pain) or allergy to known components of covid-19 vaccine; history of thrombocytopenia or other coagulation disorders; patients with known immunological impairment or immunocompromised. received whole blood, blood products, plasma and/or immunoglobulin therapy within 3 months before study enrollment have known or suspected severe illness such as respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumour, infectious or allergic skin disease, human immunodeficiency virus (hiv) infection (test report available); diagnosed with serious cardiovascular diseases such as cardiopulmonary failure, drug-uncontrolled hypertension (systolic blood pressure 160 mmhg and/or diastolic blood pressure 95 mmhg). received live attenuated vaccines within 1 month before study enrollment; received inactivated vaccines within 14 days before study enrollment; received other investigational drugs within 6 months before study enrollment; other vaccination-related contraindications considered by investigators.

2

National Vaccine and Serum Institute, China

18

100

United Arab Emirates

Healthy volunteers

N/A

516

GMT (Omicron) of anti-SARS-CoV-2 neutralizing antibody in adults ≥18 years of age;the 4-fold rise rate of anti-omicron neutralizing antibody in adults ≥18 years of age;The incidence of AESI observed;The incidence of SAE observed;The incidence rate of any adverse reactions/events;The incidence rate of solicited adverse reactions/events;The incidence rate of solicited adverse reactions/events;The incidence severity of any adverse reactions/events;The incidence severity of solicited adverse reactions/events;The incidence severity of solicited adverse reactions/events

None

Phase 2

[{"arm_notes": "nan", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 1923, "treatment_name": "Inactivated sars-cov-2 vaccine (vero cell)", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]