Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and 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 and MMR in day 28. Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28. Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
540
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai Municipality, China
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity
Time frame: on day 28 after vaccination
non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity
Time frame: on day 28 after vaccination
non-inferiority of the seroconversion rate and IgG antibody level against varicella
IgG antibodies of varicella is an index of immunogenicity
Time frame: on day 28 after vaccination
incidence of reported vaccine-related adverse events within 28 days of each immunization.
adverse events including local and systemic symptoms followng immunization
Time frame: from 0 to 28 days after vaccination
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