Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 100
Summary
- Conditions
- Flu
- Influenza
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Phase I-like, open-label, descriptive, monocenter study, which includes 5 groups of participants of varying ages and dosesMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 6 years and 125 years
- Gender
- Both males and females
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 a...
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.
Tracking Information
- NCT #
- NCT03430089
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Director Sanofi Pasteur, a Sanofi Company
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