drugset / Trial / NCT05245552
A Clinical Trial of Quadrivalent Influenza Vaccine in Healthy Subjects Aged 6 to 35 Months
RandomizedParallel-groupDouble-blindPrevention
Summary
The study of quadrivalent influenza vaccine manufactured by Sinovac Biotech Co., Ltd will conduct in two phases,the phaseⅠclinical trial of the study will be open-label design,and the phase III clinical trial of the study will be randomized, double-blind, active controlled design.the purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy subjects aged 6 to 35 months.
Timeline
- Start
- 2022-08-08
- Primary completion
- 2023-08-04
- Completion
- 2023-08-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Quadrivalent influenza vaccine | Vaccine | 0.25 ml | Intramuscular |
| Subject | Quadrivalent influenza vaccine | Vaccine | 0.5 ml | Intramuscular |
| Comparator | Trivalent influenza vaccine(BV) | Vaccine | 0.25 ml | Intramuscular |
| Comparator | Trivalent influenza vaccine(BY) | Vaccine | 0.25 ml | Intramuscular |