NCT03430089

Safety of a Single Dose or Two Doses of Shenzhen Quadrivalent Influenza Vaccine

Safety of a Single Dose (Participants Aged 9 Years and Older) or Two Doses Given 28 Days Apart (Participants Aged 6 Months to 8 Years) of the Shenzhen Quadrivalent Influenza Vaccine (Split Virion), Inactivated

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Influenza
• Flu

Interventions

Type	Name	Description
BIOLOGICAL	Shz QIV 0.25 mL, 2 doses	Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart.
BIOLOGICAL	Shz QIV 0.5 mL, 2 doses	Administered intramuscularly into the deltoid muscle, 28 days apart
BIOLOGICAL	Shz QIV 0.5 mL, single dose	Administered intramuscularly into the deltoid muscle.

Timeline

• Start date: 2019-02-22
• Primary completion: 2019-06-06
• Completion: 2019-06-06
• First posted: 2018-02-12
• Last updated: 2022-11-09

Locations

1 site across 1 country: China