Status:
UNKNOWN
A PhaseⅡ Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine
Lead Sponsor:
CNBG-Virogin Biotech (Shanghai) Ltd.
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
To evaluate the immunogenicity and safety of a COVID-19 mRNA vaccine (ZSVG-02-O) in a healthy population aged 18 years and older.
Detailed Description
This study uses a randomized, blinded and controlled design, with age stratification of 18-59 years and ≥60 years , including the test vaccine at different doses (30 μg and 60 μg) and an active contro...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy male or female subjects aged ≥18 years of age;
- Subjects who are in good physical condition as judged by the investigator based on medical history, physical examination and clinical laboratory tests;
- Subjects who have not been previously vaccinated with a Covid-19 vaccine or who have received the last dose (total dose ≤ 3 doses) of a Covid-19 vaccine at least 6 months ago;
- Subjects who have not been previously infected with Covid-19, or whose nucleic acid or antigen test has turned negative for more than 3 months after previous Covid-19 infection;
- Subjects are able to understand the study procedures, have provide written informed consent, and are able to comply with the requirements of the clinical study protocol.
- Exclusion criteria
- Axillary temperature ≥37.3°C;
- Positive polymerase chain reaction (PCR) test results within the last 48 hours;
- Women of childbearing potential with a positive urine pregnancy test result, or who are pregnant or breastfeeding, or who have not used effective contraception within 2 weeks prior to enrolment, or women and men who plan to have children within 12 months after full immunisation;
- History of epilepsy, convulsions or seizures, psychosis or family history of psychosis;
- Have a history of severe allergy to any medication or vaccination (e.g. acute allergic reaction, urticaria, skin eczema, dyspnoea, angioneurotic oedema, or abdominal pain) or allergy to known components of a Covid-19 vaccine;
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders;
- Have a history of hospital-diagnosed known immunological impairment or hypofunction;
- Subjects who have received whole blood, plasma or immunoglobulin therapy within 3 months;
- Known or suspected concomitant serious diseases, including: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, severe diabetes, malignant tumours, infectious or allergic skin diseases, and HIV infection (with test report);
- Have serious cardiovascular diseases, cardiopulmonary failure, hypertension that cannot be controlled by medication (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg on physical examination);
- Received live attenuated vaccine within 1 month prior to vaccination or other vaccines within 14 days prior to vaccination;
- Participation in a clinical trial of another drug within 3 months prior to the first dose of vaccine or planning to participate in a clinical trial of another drug during the study period;
- Any other conditions that the investigator considers inappropriate for participation in this study.
Exclusion
Key Trial Info
Start Date :
July 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
980 Patients enrolled
Trial Details
Trial ID
NCT06113731
Start Date
July 10 2023
End Date
October 1 2024
Last Update
November 8 2023
Active Locations (2)
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1
Dengfeng Centre for Disease Control and Prevention and Control
Songyang, Henan, China
2
Henan Provincial Centre for Disease Control and Prevention
Zhengzhou, Henan, China