Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-02-23 @ 6:25 AM
Study NCT ID:
NCT00976469
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2009-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A/H1N1 Immunogenicity and Safety in Infants, Children and Adolescents
Sponsor:
Alachua Government Services, Inc.
Organization:
Study Overview
Official Title:
An Open-Label Phase 1/2 Study to Assess the Immunogenicity and Safety of Two Different Dose Levels of H1N1 Pandemic Influenza Vaccine in Healthy Infants, Children and Adolescents Aged 6 Months to 17 Years
Status:
COMPLETED
Status Verified Date:
2011-05
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 determine the preferred dose of H1N1 pandemic influenza vaccine in a pediatric population, aged 6 months to 17 years, based upon assessments of immunogenicity and safety.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EUDRACT Number 2009-013131-38 | None | None | View |