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

Primary Purpose

SARS-CoV-2 Infection, Varicella, Measles

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
Inactivated SARS-CoV-2 vaccine coadministered with MMR
Inactivated SARS-CoV-2 vaccine administered alone
Sponsored by
Shanghai Municipal Center for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SARS-CoV-2 Infection focused on measuring Inactivated SARS-CoV-2 vaccine, coadministeration, varicella vaccine, measles, mumps and rubella combined vaccine

Eligibility Criteria

4 Years - 4 Years (Child)All SexesAccepts 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

Sites / Locations

  • Shanghai Municipal Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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
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
non-inferiority of the seroconversion rate and IgG antibody level against varicella
IgG antibodies of varicella is an index of immunogenicity

Secondary Outcome Measures

incidence of reported vaccine-related adverse events within 28 days of each immunization.
adverse events including local and systemic symptoms followng immunization

Full Information

First Posted
July 17, 2023
Last Updated
July 17, 2023
Sponsor
Shanghai Municipal Center for Disease Control and Prevention
Collaborators
China National Biotec Group Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05952505
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Municipal Center for Disease Control and Prevention
Collaborators
China National Biotec Group Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection, Varicella, Measles, Mumps, Rubella
Keywords
Inactivated SARS-CoV-2 vaccine, coadministeration, varicella vaccine, measles, mumps and rubella combined vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Arm Title
Group 2
Arm Type
Experimental
Arm Description
immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
Intervention Description
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 vaccine coadministered with MMR
Intervention Description
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Intervention Type
Biological
Intervention Name(s)
Inactivated SARS-CoV-2 vaccine administered alone
Intervention Description
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
Primary Outcome Measure Information:
Title
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
Description
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity
Time Frame
on day 28 after vaccination
Title
non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps
Description
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity
Time Frame
on day 28 after vaccination
Title
non-inferiority of the seroconversion rate and IgG antibody level against varicella
Description
IgG antibodies of varicella is an index of immunogenicity
Time Frame
on day 28 after vaccination
Secondary Outcome Measure Information:
Title
incidence of reported vaccine-related adverse events within 28 days of each immunization.
Description
adverse events including local and systemic symptoms followng immunization
Time Frame
from 0 to 28 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhuoying Huang
Phone
86-21-62758710
Email
huangzhuoying@scdc.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuoying Huang
Organizational Affiliation
Shanghai Municipal Center for Disease Control and Prevention
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Municipal Center for Disease Control and Prevention
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
021
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhuoying Huang
Phone
86-21-62758710
Email
huangzhuoying@scdc.sh.cn

12. IPD Sharing Statement

Learn more about this trial

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

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