Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 3

Conditions: SARS-CoV2 Infection

Treatments: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

Study type: Interventional

Funder types: Other

Identifiers

NCT05164731

20211102

Details and patient eligibility

About

To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.

Enrollment: 880 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Axillary temperature ≤37.0 ℃.
2. aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
3. Proven legal identity, could come each visit.
4. Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.

Exclusion criteria

1. Persons with a clear history of SARS-CoV-2 infection.
2. Using blood products after basic immunization or receiving immunosuppressive therapy.
3. Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
4. Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
5. History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
6. Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
7. Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
8. Immunization with any vaccine within 14 days.
9. Any other situations judged by investigators as not suitable for participating in this study.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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880 participants in 4 patient groups

3 months after two doses

Experimental group

Description:

the third does was given 3 months after two doses

Treatment:

Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

4 months after two doses

Experimental group

Description:

the third does was given 4 months after two doses

Treatment:

Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

5 months after two doses

Experimental group

Description:

the third does was given 5 months after two doses

Treatment:

Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)

6 months after two doses

Experimental group

Description:

the third does was given 6 months after two doses

Treatment:

Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)