Status:
UNKNOWN
A Study to Evaluate the Safety and Immunogenicity of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in Population 18 Years Old of Age and Above
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Beijing Institute of Biological Products Co Ltd.
Shulan (Hangzhou) Hospital
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2023
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05365724
Start Date
May 1 2022
End Date
October 1 2023
Last Update
June 18 2023
Active Locations (1)
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1
Shulan (hangzhou) Hospital
Hangzhou, Zhejiang, China