drugset / Trial / NCT05952505
Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines
Phase 4
Unknown
540 enrolled
Shanghai Municipal Center for Disease Control and Prevention
China National Biotec Group Company Limited · collab
RandomizedParallel-groupOpen-labelPrevention
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.
Timeline
- Start
- 2023-08
- Primary completion
- 2023-12
- Completion
- 2024-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Varicella vaccine | Vaccine | — | — |
| Comparator | inactivated SARS-CoV-2 vaccine | Vaccine | — | — |
| Subject | measles-mumps-rubella vaccine | Vaccine | — | — |