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

• ClinicalTrials.gov Identifier: NCT05952505
• Recruitment Status: Not yet recruiting
• First Posted: July 19, 2023
• Last Update Posted: July 19, 2023
• Sponsor: Shanghai Municipal Center for Disease Control and Prevention
• Collaborator: China National Biotec Group Company Limited
• Information provided by (Responsible Party): HUANG Zhuoying, Shanghai Municipal Center for Disease Control and Prevention

Tracking Information

• First Submitted Date: July 17, 2023
• First Posted Date: July 19, 2023
• Last Update Posted Date: July 19, 2023
• Estimated Study Start Date: August 2023
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 17, 2023)

• 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
• 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
• 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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: July 17, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• SARS-CoV-2 Infection
• Varicella
• Measles
• Mumps
• Rubella

Intervention

• Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
  Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
• Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
  Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
• Biological: Inactivated SARS-CoV-2 vaccine administered alone
  Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone

Study Arms

• 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.
  Intervention: Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
• Experimental: Group 2
  immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
  Intervention: Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
• Active Comparator: Group 3
  immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
  Intervention: Biological: Inactivated SARS-CoV-2 vaccine administered alone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 17, 2023): 540
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 4 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05952505
• Other Study ID Numbers: SH2023-9
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: HUANG Zhuoying, Shanghai Municipal Center for Disease Control and Prevention
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai Municipal Center for Disease Control and Prevention
• Original Study Sponsor: Same as current
• Collaborators: China National Biotec Group Company Limited

Investigators

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

• PRS Account: Shanghai Municipal Center for Disease Control and Prevention
• Verification Date: July 2023