Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 9:21 AM
Study NCT ID:
NCT03391193
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2017-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of a Multi-Dose Quadrivalent Influenza Vaccine in Children Aged 6 Months to 17 Years
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: