Back to resultsStudy on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above (COVID-19)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring COVID-19, vaccine, inactivated vaccine
Eligibility Criteria
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.
- Has been vaccinated 2 or 3 doses of inactivated COVID-19 vaccine manufactured by BIBP more than 3 months.
- 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 Criteria:
- Confirmed or suspected cases of SARS-CoV-2 Infection.
- Has a history of SARS, MERS, SARS-CoV-2 infection (self-report, on-site inquiry).
- Received one dose or more than 3 doses of inactivated COVID-19 vaccine manufactured by BIBP
- Received COVID-19 vaccine manufactured bu other companies (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
- Received live attenuated vaccine within 1 month before enrollment.
- Received other vaccines within 14 days before enrollment.
- Be participating in or plan to participate in other vaccine clinical trials during this study.
- Contraindications related to vaccination as considered by other investigators.
Sites / Locations
- Linli County Center for Disease Control and Prevention
- Changning Center for Disease Control and Prevention
- Ningxiang Center for Disease Control and Prevention
- Outpatient Department of Hunan Provincial Center for Disease Control and Prevention
- Loudi Public Health Hospital
- Xiangtan Center for Disease Control and Prevention
- Xiangxiang Center for Disease Control and Prevention
- Luxi County Center for Disease Control and Prevention
- Huarong County Center for Disease Control and Prevention
- You County Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm 24
Arm 25
Arm 26
Arm 27
Arm 28
Experimental
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A1：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
A2：one dose, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
B1：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
B2：one dose, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
B3：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
B4：one dose, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination
C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination
D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination
D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination
D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination
D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination
E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination
E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination
F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination
F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination
F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive one dose from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 2 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 18-59 years old will be blinded and receive two doses of vaccine with 28 days apart more than 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 3 months to 6 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
subjects aged 60 years old and above will be blinded and receive two doses of vaccine with 28 days apart from 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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