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

July 17, 2023 updated by: HUANG Zhuoying, Shanghai Municipal Center for Disease Control and Prevention

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 021
        • Shanghai Municipal Center for Disease Control and Prevention
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
Experimental: Group 2
immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
Active Comparator: Group 3
immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Biological: Inactivated SARS-CoV-2 vaccine administered alone
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2
Time Frame: on day 28 after vaccination
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
Time Frame: on day 28 after vaccination
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
Time Frame: on day 28 after vaccination
IgG antibodies of varicella is an index of immunogenicity
on day 28 after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of reported vaccine-related adverse events within 28 days of each immunization.
Time Frame: from 0 to 28 days after vaccination
adverse events including local and systemic symptoms followng immunization
from 0 to 28 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Municipal Center for Disease Control and Prevention

Collaborators

China National Biotec Group Company Limited

Investigators

  • Study Director: Zhuoying Huang, Shanghai Municipal Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 17, 2023

First Submitted That Met QC Criteria

July 17, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH2023-9

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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