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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05952505
Recruitment Status : Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
Sponsor:
Collaborator:
China National Biotec Group Company Limited
Information provided by (Responsible Party):
HUANG Zhuoying, Shanghai Municipal Center for Disease Control and Prevention

Study Description
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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.


Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Varicella Measles Mumps Rubella Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR Biological: Inactivated SARS-CoV-2 vaccine administered alone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05952505


Contacts
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Contact: Zhuoying Huang 86-21-62758710 huangzhuoying@scdc.sh.cn

Locations
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China, Shanghai
Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai, China, 021
Contact: Zhuoying Huang    86-21-62758710    huangzhuoying@scdc.sh.cn   
Sponsors and Collaborators
Shanghai Municipal Center for Disease Control and Prevention
China National Biotec Group Company Limited
Investigators
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Study Director: Zhuoying Huang Shanghai Municipal Center for Disease Control and Prevention
More Information
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Responsible Party: HUANG Zhuoying, Doctor, Shanghai Municipal Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT05952505    
Other Study ID Numbers: SH2023-9
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by HUANG Zhuoying, Shanghai Municipal Center for Disease Control and Prevention:
Inactivated SARS-CoV-2 vaccine
coadministeration
varicella vaccine
measles, mumps and rubella combined vaccine
Additional relevant MeSH terms:
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COVID-19
Measles
Chickenpox
Herpes Zoster
Rubella
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs