NCT05952505

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Shanghai Municipal Center for Disease Control and Prevention · Academic / Other
• Sex: All
• Age: 4 Years – 4 Years
• Healthy volunteers: Accepted

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

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2023-07-19
• Last updated: 2023-07-19

Locations

1 site across 1 country: China