Status:
UNKNOWN
Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above
Lead Sponsor:
China National Biotec Group Company Limited
Collaborating Sponsors:
Beijing Institute of Biological Products Co Ltd.
Wuhan Institute of Biological Products Co., Ltd
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or ...
Eligibility Criteria
Inclusion
- Age range: populations aged 18 years and above.
- Judged by the investigator that the health condition is well after inquiry and physical examination.
- Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for ≥ 3 months.
- Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 7 months after enrollment. 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 is able to comply with the requirements of the clinical study protocol.
Exclusion
- Confirmed cases, suspected cases or asymptomatic cases of COVID-19;
- With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (self-report, on-site inquiry);
- Has vaccinated with one or four doses and above COVID-19 vaccine;
- Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃);
- Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite enquiry);
- Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry);
- With known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry);
- Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry);
- Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry);
- Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, Human Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test report if available);
- With hospital-diagnosed serious cardiovascular diseases (cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg), acute attacks of chronic respiratory illness (self-report, onsite enquiry);
- Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry);
- Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry);
- Participating or planning to participate in other interventional vaccine clinical trials during this study
- Other vaccination-related contraindications considered by investigators.
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
1804 Patients enrolled
Trial Details
Trial ID
NCT05382871
Start Date
May 27 2022
End Date
March 31 2024
Last Update
June 18 2023
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong