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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05952505

Enrollment

540

Registered

2023-07-19

Start date

2023-08-31

Completion date

2024-12-31

Last updated

2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Inactivated SARS-CoV-2 vaccine, coadministeration, varicella vaccine, measles, mumps and rubella combined vaccine

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.

Interventions

BIOLOGICALInactivated SARS-CoV-2 vaccine coadministered with vricella vaccine

Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.

BIOLOGICALInactivated SARS-CoV-2 vaccine coadministered with MMR

Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.

BIOLOGICALInactivated SARS-CoV-2 vaccine administered alone

Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 4 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactZhuoying Huang

huangzhuoying@scdc.sh.cn86-21-62758710

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026