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 randomizationstratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccineand 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 andMMR in day 28.Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR andvaricella vaccine in day 28.Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28before vaccination, and on day 56. Local and systemic symptoms and serious adverse eventsfollowing immunzation were collected.

Detailed Description

Not Provided

Not yet recruiting
SARS-CoV-2 Infection
Varicella
Measles
Mumps
Rubella

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

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

Eligibility Gender
All
Eligibility Age
Minimum: 4 Years ~ Maximum: 4 Years
Countries
China
Locations

Shanghai Municipal Center for Disease Control and Prevention
Shanghai, Shanghai, China

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

Contacts

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

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

China National Biotec Group Company Limited
NCT Number
Keywords
Inactivated SARS-CoV-2 Vaccine
coadministeration
varicella vaccine
measles, mumps and rubella combined vaccine
MeSH Terms
COVID-19
Measles
Chickenpox
Herpes Zoster
Rubella
Vaccines