drugset / Trial / NCT02964065
A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)
Phase 3
Completed
9000 enrolled
Changchun BCHT Biotechnology Co.
Baoding Municipal Center for Disease Control and Prevention, Hebei, P.R.China · collabDepartment of Medical Statistics, Fourth Military Medical University · collabMaoming Municipal Center for Disease Control and Prevention, Guangdong, P.R.China · collabNational Institutes for Food and Drug Control, China · collabSimoon Record Pharma Information Consulting Co., Ltd. · collabZhejiang Provincial Center for Disease Control and Prevention · collab
RandomizedParallel-groupTriple-blindPrevention
Summary
This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.
Timeline
- Start
- 2016-11
- Primary completion
- 2017-08
- Completion
- —
Publications
- Ai L, Gao Z, Lv H, Zhang J, Xu N, Zhao H, Lu Q, Zhu H, Shi N, Wei W, Liu D, Yu Q. Immunogenicity and safety of live attenuated influenza vaccine in children aged 3-17 years in China. Vaccine. 2025 Feb 6;46:126653. doi: 10.1016/j.vaccine.2024.126653. Epub 2024 Dec 26.
- Wang S, Zheng Y, Jin X, Gan Z, Shao Y, Zhu C, Hu X, Liang Z, Chen Y, Xing B, Lv H, Xu N. Efficacy and safety of a live attenuated influenza vaccine in Chinese healthy children aged 3-17 years in one study center of a randomized, double-blind, placebo-controlled phase 3 clinical trial, 2016/17 season. Vaccine. 2020 Aug 27;38(38):5979-5986. doi: 10.1016/j.vaccine.2020.07.019. Epub 2020 Jul 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FluMist | Vaccine | 0.2 ml | — |