Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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SARS-CoV-2 Infection, Varicella, Measles, Mumps, Rubella

Intervention / Treatment
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* Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
* Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
* Biological: Inactivated SARS-CoV-2 vaccine administered alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28. | Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine<br>* Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.<br>|
| Experimental: Group 2<br>immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28. | Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR<br>* Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.<br>|
| Active Comparator: Group 3<br>immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28. | Biological: Inactivated SARS-CoV-2 vaccine administered alone<br>* Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | on day 28 after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of reported vaccine-related adverse events within 28 days of each immunization. | adverse events including local and systemic symptoms followng immunization | from 0 to 28 days after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inactivated SARS-CoV-2 vaccine, coadministeration, varicella vaccine, measles, mumps and rubella combined vaccine