Clinical trial NCT05952505: Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: SARS-CoV-2 Infection
Varicella
Measles
Mumps
Rubella
Keywords: Inactivated SARS-CoV-2 vaccine
coadministeration
varicella vaccine
measles, mumps and rubella combined vaccine
Lead sponsor: Shanghai Municipal Center for Disease Control and Prevention
Sponsor class: OTHER
Collaborators: name: China National Biotec Group Company Limited
First posted: 2023-07-19
Enrollment: 540
Sex: ALL
Minimum age (years): 4
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
timeFrame: on day 28 after vaccination
measure: non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
timeFrame: on day 28 after vaccination
measure: non-inferiority of the seroconversion rate and IgG antibody level against varicella
timeFrame: on day 28 after vaccination
Secondary outcomes:
measure: incidence of reported vaccine-related adverse events within 28 days of each immunization.
timeFrame: from 0 to 28 days after vaccination
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Municipal Center for Disease Control and Prevention
state: Shanghai
Study officials:
affiliation: Shanghai Municipal Center for Disease Control and Prevention
name: Zhuoying Huang
role: STUDY_DIRECTOR
References: