Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT00885105
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2009-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age
Status:
COMPLETED
Status Verified Date:
2016-04
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 study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.
Observational Objectives:
* To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
* To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
* To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
Observational Objectives:
* To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
* To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
* To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.
Detailed Description:
This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.
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?: