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

SARS-CoV-2 Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05952505
• Other study ID #: SH2023-9
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2023
• Est. completion date: December 2024

Study information

• Verified date: July 2023
• Source: Shanghai Municipal Center for Disease Control and Prevention
• Contact: Zhuoying Huang
• Phone: 86-21-62758710
• Email: huangzhuoying[@]scdc.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 540
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Chickenpox
• COVID-19
• Herpes Zoster
• Measles
• Mumps
• Rubella
• SARS-CoV-2 Infection
• Varicella

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Municipal Center for Disease Control and Prevention	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Municipal Center for Disease Control and Prevention	China National Biotec Group Company Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	incidence of reported vaccine-related adverse events within 28 days of each immunization.	adverse events including local and systemic symptoms followng immunization	from 0 to 28 days after vaccination