Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00502593
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2007-07-16
Brief Title:
Evaluate Safety Immunogenicity of a Pandemic Influenza Vaccine GSK1562902A in Children
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Randomized Open Controlled Study to Evaluate the Safety and Immunogenicity of Different Formulations of a Pandemic Influenza Vaccine Candidate Split Virus Formulation Adjuvanted With AS03 Given Following a Two-administration Schedule 21 Days Apart in Children Between 3 and 9 Years of Age
Status:
COMPLETED
Status Verified Date:
2017-06
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 present study is designed to evaluate in children aged between 3 and 9 years the immunogenicity and safety of different antigen doses of the candidate vaccine GSK1562902A administered following a two-administration schedule 21 days apart Subjects in the control group will receive Fluarix The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
This 107066 study is a participating study to the broader NCT00502593 study which included 2 other studies the 108498 and 108500 studies The NCT00502593 study had a staggered design subjects from each group being enrolled sequentially into 2 age strata 6-9 years 1st and 3-5 years next and was run in 3 phases phases A Study 107066 B Study 108498 and C Study 108500 In each phase the decision to vaccinate subjects aged 3-5 years and to administer a 2nd injection to subjects aged 6-9 years was made based on safety data collected on Days 0-6 after the 1st injection for the subjects aged 6-9 years Decision to start Phase B was made on complete safety data including those collected on Day 28 of Phase A 7 days after the 2nd injection for each age group A similar approach was to be used to start Phase C As safety data in Phase A did not raise any safety concerns Phases B and C were run in parallel
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 108500 | OTHER | GSK | None |
| 108498 | OTHER | None | None |