drugset / Trial / NCT05642078
Phase Ⅲ Clinical Study of Quadrivalent Influenza Virus Split Vaccine
RandomizedParallel-groupQuadruple-blindPrevention
Summary
A randomized, blind, positive vaccine control trial was designed.A total of 2550 subjects aged 6-35 months were randomly assigned to the low dose (0.25ml/ dose) group, the high dose (0.5ml/ dose) group and the control group in a ratio of 1:1:1. They were inoculated with 2 doses of quadrivalent influenza virus split vaccine (experimental vaccine or control vaccine) at 0 and 28 days of immunization program to observe the Immunogenicity and safety.
Timeline
- Start
- 2023-02-18
- Primary completion
- 2024-01-05
- Completion
- 2024-01-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Influenza Vaccine (Split Virion), Inactivated, Quadrivalent | Vaccine | 0.25 ml | — |
| Subject | Quadrivalent influenza vaccine(Split Virion),Inactivated | Vaccine | 0.25 ml | — |
| Subject | Quadrivalent influenza vaccine(Split Virion),Inactivated | Vaccine | 0.5 ml | — |
Indications
No indication recorded.