Study on Sequential Immunization of Omicron Inactivated COVID-19 Vaccine and Prototype Inactivated COVID-19 Vaccine in Population Aged 18 Years Old and Above
NCT ID: NCT05374954
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
4200 participants
INTERVENTIONAL
2022-05-10
2023-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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A1：one dose, 18-59 years old, from 3 months to 6 months after 2 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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
A2：one dose, 18-59 years old, from 3 months to 6 months after 2 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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
A3：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
A4：one dose, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
B1：one dose, 18-59 years old, from 3 months to 6 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 3 doses of inactivated COVID-19 vaccine
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
B2：one dose, 18-59 years old, from 3 months to 6 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 3 doses of inactivated COVID-19 vaccine
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
B3：one dose, 18-59 years old, 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 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
B4：one dose, 18-59 years old, 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 6 months to 12 months after 3 doses of inactivated COVID-19 vaccine
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
C1：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
C2：two doses, 18-59 years old, from 3 months to 6 months after 2 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
C3：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
C4：two doses, 18-59 years old, from 6 months to 12 months after 2 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
C5：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
C6：two doses, 18-59 years old, more than 12 months after 2 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
D1：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
D2：two doses, 60 years old and above, from 3 months to 6 months after 2 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
D3：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
D4：two doses, 60 years old and above, from 6 months to 12 months after 2 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
E1：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
E2：two doses, 18-59 years old, from 3 months to 6 months after 3 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
E3：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
E4：two doses, 18-59 years old, from 6 months to 12 months after 3 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
E5：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
E6：two doses, 18-59 years old, more than 12 months after 3 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
F1：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
F2：two doses, 60 years old and above, from 3 months to 6 months after 3 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
F3：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
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
Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
F4：two doses, 60 years old and above, from 6 months to 12 months after 3 doses of vaccination
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
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
Interventions
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Omicron COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
COVID-19 Vaccine (Vero Cell), Inactivated
intramuscular injection in the deltoid muscle
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Beijing Institute of Biological Products Co Ltd.
INDUSTRY
Hunan Provincial Center for Disease Control and Prevention
OTHER
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Locations
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Linli County Center for Disease Control and Prevention
Changde, Hunan, China
Changning Center for Disease Control and Prevention
Changning, Hunan, China
Ningxiang Center for Disease Control and Prevention
Changsha, Hunan, China
Outpatient Department of Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Loudi Public Health Hospital
Loudi, Hunan, China
Xiangtan Center for Disease Control and Prevention
Xiangtan, Hunan, China
Luxi County Center for Disease Control and Prevention
Xiangxi, Hunan, China
Xiangxiang Center for Disease Control and Prevention
Xiangxiang, Hunan, China
Huarong County Center for Disease Control and Prevention
Yueyang, Hunan, China
You County Center for Disease Control and Prevention
Zhuzhou, Hunan, China
Countries
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Other Identifiers
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CNBG-BIBP-O-2022004
Identifier Type: -
Identifier Source: org_study_id
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