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

NCT05952505 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-07-19

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • China National Biotec Group Company Limited

    collaborator INDUSTRY

  • Shanghai Municipal Center for Disease Control and Prevention

    lead OTHER

Principal Investigators

  • Zhuoying Huang · Shanghai Municipal Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
4 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05952505 on ClinicalTrials.gov