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Clinical Trial Summary

This phase I-like, open-label, monocenter, descriptive, single-arm clinical safety study will investigate the Shenzhen quadrivalent influenza vaccine (Shz QIV) in 100 participants aged 6 months and older in China. Participants aged 9 years or more will receive a single dose of Shz QIV, and participants aged 6 months to 8 years will receive two doses of Shz QIV administered 28 days apart.


Clinical Trial Description

Healthy participants will either receive a single dose (participants 9 years or older) or two doses (participants 6 months to 8 years) of the Shz QIV. Safety in terms of serious adverse events, solicited injection site and systemic reactions, and unsolicited adverse events will be collected before and 28 days after each and any dose. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03430089
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 1
Start date February 22, 2019
Completion date June 6, 2019

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