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

Shanghai Municipal Center for Disease Control and Prevention

Status and phase: Not yet enrolling; Phase 4

Conditions: Rubella; SARS-CoV-2 Infection; Varicella; Mumps; Measles

Treatments: Biological: Inactivated SARS-CoV-2 vaccine administered alone; Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR; Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05952505

SH2023-9

Details and patient eligibility

About

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 4 to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 3 patient groups

Group 1

Experimental group

Description:

immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.

Treatment:

Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine

Group 2

Experimental group

Description:

immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.

Treatment:

Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR

Group 3

Active Comparator group

Description:

immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.

Treatment:

Biological: Inactivated SARS-CoV-2 vaccine administered alone