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

SH2023-9

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.

2023-08-01

2023-12-01

2024-12-01

Not yet recruiting

Early phase I

540

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 540, 'type': 'ESTIMATED'}}

2023-07-19