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Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Varicella Vaccine and Measles, Mumps and Rubella Combined Vaccine in Shanghai, China: A Non-inferiority, Open-label, Randomised, Controlled, Phase 4 Trial
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.
Details
| Lead sponsor | Shanghai Municipal Center for Disease Control and Prevention |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 540 |
| Start date | 2023-08 |
| Completion | 2024-12 |
Conditions
- SARS-CoV-2 Infection
- Varicella
- Measles
- Mumps
- Rubella
Interventions
- Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
- Inactivated SARS-CoV-2 vaccine coadministered with MMR
- Inactivated SARS-CoV-2 vaccine administered alone
Primary outcomes
- non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2 — on day 28 after vaccination
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity - non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps — on day 28 after vaccination
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity - non-inferiority of the seroconversion rate and IgG antibody level against varicella — on day 28 after vaccination
IgG antibodies of varicella is an index of immunogenicity
Countries
China