Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines
1 other identifier
interventional
540
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 19, 2023
July 1, 2023
4 months
July 17, 2023
July 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (1)
incidence of reported vaccine-related adverse events within 28 days of each immunization.
from 0 to 28 days after vaccination
Study Arms (3)
Group 1
EXPERIMENTALimmunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Group 2
EXPERIMENTALimmunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Group 3
ACTIVE COMPARATORimmunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Interventions
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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 situation that researchers thought that might influence the consequence of the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai Municipality, 021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zhuoying Huang
Shanghai Municipal Center for Disease Control and Prevention
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 19, 2023
Study Start
August 1, 2023
Primary Completion
December 1, 2023
Study Completion
December 1, 2024
Last Updated
July 19, 2023
Record last verified: 2023-07