To Identify the Immunogenicity and Safety of QIV in Children Aged 3-8 Years
Summary
To explore the immunogenicity and safety of quadrivalent split influenza virus vaccine in children aged 3-8 years with two doses and one dose. This clinical trial was designed as a self-controlled trial to observe the immunogenicity and safety. This study was an exploratory study. Sample size and test grouping: In this study, a total of 360 subjects were enrolled in a self-controlled trial design. In this study, 360 subjects aged 3 to 8 years old were enrolled. According to their previous influenza vaccine vaccination status, they were assigned to experimental group 1 (no previous influenza vaccine), experimental group 2 (one dose of influenza vaccine previously) and experimental group 3 (two or more doses of influenza vaccine previously), with 120 cases in each experimental group. All subjects received one dose of tetravalent influenza virus lysis vaccine on day 0,28 for immunogenicity and safety observation.
Timeline
- Start
- 2022-03-02
- Primary completion
- 2022-05
- Completion
- 2022-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inavtivated Quadrivalent Influenza Virus Split Vaccine | Vaccine | — | — |