Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00956202
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2009-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Inactivated Swine-Origin A/H1N1 Influenza Vaccines in Healthy European Subjects Aged 3 to 17 Years
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 3 to 17 Years
Status:
COMPLETED
Status Verified Date:
2014-01
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 purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
* To describe the immune response to vaccines 21 days after each vaccination in all participants.
* To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants who received two injections.
* To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections.
* To describe the safety profile of each vaccine in all participants.
Primary objectives:
* To describe the immune response to vaccines 21 days after each vaccination in all participants.
* To describe the antibody persistence eight months after the first vaccine administration using HAI method, in a subset of participants who received two injections.
* To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of participants who received two injections.
* To describe the safety profile of each vaccine in all participants.
Detailed Description:
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
A subset of children and adolescents participants eligible for the antibody persistence evaluation were sampled 8 months after the first vaccination, they will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination. Immunogenicity response will be evaluated before vaccination and 21 days after vaccination with TIV, respectively.
A subset of children and adolescents participants eligible for the antibody persistence evaluation were sampled 8 months after the first vaccination, they will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination. Immunogenicity response will be evaluated before vaccination and 21 days after vaccination with TIV, respectively.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: