NCT03391193

Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine

Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 Months to 17 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to to assess the immunogenicity and safety of a quadrivalent influenza vaccine in a multi-dose presentation compared to a quadrivalent influenza vaccine in single-dose presentation, in children aged 6 months to 17 years.

Detailed description

Participants aged 9 to 17 years will receive one dose of either the multi-dose quadrivalent influenza vaccine or the quadrivalent influenza vaccine in a single-dose presentation and participants aged 6 months to 8 years will receive 2 doses of either vaccine, 28 days apart. All participants will provide a pre-vaccination blood sample on Day 0 and a post-vaccination blood sample either on Day 28 (participants aged 9 to 17 years) or on Day 56 (participants aged 6 months to 8 years) for immunogenicity testing. All participants will be followed for safety evaluation up to 6 months after the last vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Multi-dose Quadrivalent Influenza Vaccine	0.5 mL, intramuscular
BIOLOGICAL	Single-dose Quadrivalent Influenza Vaccine	0.5 mL, intramuscular

Timeline

• Start date: 2017-12-19
• Primary completion: 2018-03-28
• Completion: 2018-08-25
• First posted: 2018-01-05
• Last updated: 2022-04-25

Locations

3 sites across 1 country: Mexico