Official Title
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)
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 doseafter 6 months since finished two doses schedule of CoronaVac or BBIBP-CorV.

Detailed Description

Not Provided

Unknown status
SARS-CoV-2 Infection

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

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Xiangyang City Centers for Disease Control and Prevention
Xiangyang, Hubei, China

Investigator: Shengchun Tang, PhD

Contacts

Jingsi Yang, Master
86-0871-68334551
yjs@imbcams.com.cn

Yeqing Tong, Principal Investigator
Hubei Provincial Center for Disease Control and Prevention

Hubei Provincial Center for Disease Control and Prevention
NCT Number
MeSH Terms
COVID-19