Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above (6 Months After Two Doses)

NCT ID: NCT05216484

Last Updated: 2022-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-18
• Study Completion Date: 2022-12-30

Brief Summary

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 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.

Conditions

SARS-CoV-2 Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

two doses CoronaVac group

the third does was given 6 months after two doses CoronaVac group

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

two doses BBIBP-CorV

the third does was given 6 months after two doses BBIBP-CorV

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

first does CoronaVac and second does BBIBP-CorV

the third does was given 6 months after first does CoronaVac and second does BBIBP-CorV

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

first does BBIBP-CorV and second does CoronaVac

the third does was given 6 months after first does BBIBP-CorV and second does CoronaVac

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

Interventions

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

the third dose immunization schedule of SARS-CoV-2 inactivated vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Axillary temperature ≤37.0 ℃.

2. aged 18 years and above, after 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV, or one does CoronaVac and one does BBIBP-CorV.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hubei Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jingsi Yang

Senior Technologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yeqing Tong

Role: PRINCIPAL_INVESTIGATOR

Hubei Provincial Center for Disease Control and Prevention

Locations

Xiangyang City Centers for Disease Control and Prevention

Xiangyang, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingsi Yang, Master

Role: CONTACT

yjs@imbcams.com.cn

86-0871-68334551

Facility Contacts

Shengchun Tang, PhD

Role: primary

Other Identifiers

20211103

Identifier Type: -

Identifier Source: org_study_id