Eligible participants were randomly assigned (1:1:1), using block randomizationstratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccineand varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine andMMR in day 28.Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR andvaricella vaccine in day 28.Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28before vaccination, and on day 56. Local and systemic symptoms and serious adverse eventsfollowing immunzation were collected.
Not Provided
Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella
vaccine.
Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Biological: Inactivated SARS-CoV-2 vaccine administered alone
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
Inclusion Criteria:
- Aged 4 years old
- With legal guardian signing the informed consent
- Able to participate in all planned visits and comply with all research procedures
(such as completing diary cards of adverse events and participating visits)
- With clear vaccination records including no SARS-CoV-2 vaccine history, with 1
varicella vaccine and 2 measles-containing vaccines history
- the last attenuated vaccine was administered ≥28 days ago, and other vaccines
administered ≥14 days ago
- With an axillary temperature ≤37.5℃ at the time of vaccination
Exclusion Criteria:
First dose exclusion criteria:
- With SARS-CoV-2 infection in the last 3 months (any of the following conditions
shall be met: positive nucleic acid test; positive antigen test; suspected
SARS-CoV-2 infection symptoms of subject or close contacts)
- allergic to any substance of the vaccine or with a severe allergic reactions history
of vaccines (such as acute allergic reactions, angioneurotic edema, breathing
difficulties, etc.)
- Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a
history of Gribali syndrome
- With acute illness, severe or acute attack of chronic illness or fever
- With immunodeficiency or weakened immune system or being treated with
immunosuppressant drugs (oral steroids)
- Received non specific immunoglobulin within 3 months
- Any situation that researchers thought that might influence the consequence of the
clinical trial Second dose exclusion criteria:
- Occurrence of any serious adverse event that may be related to the previous dose of
study vaccine
- Occurrence of systemic adverse reactions or allergic reactions with a severity level
≥ 3 recognized by researchers after vaccination
- Any new situations that fit the first dose exclusion criteria
- Any situation that researchers thought that might influence the consequence of the
clinical trial
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai, China
Investigator: Zhuoying Huang
Contact: 86-21-62758710
huangzhuoying@scdc.sh.cn
Zhuoying Huang
86-21-62758710
huangzhuoying@scdc.sh.cn
Zhuoying Huang, Study Director
Shanghai Municipal Center for Disease Control and Prevention