Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327184
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2006-05-16
Brief Title:
Primary Booster Study in Infants to Demonstrate Non-inferiority Persistence Immunogenicity of Hib-MenC Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study to Demonstrate Non-inferiority of GSK Biologicals Hib-MenC Given With Infanrix Penta Versus NeisVac-C Given With Infanrix Hexa at 3 5 Months of Age and Persistence Prior to a Hib-MenC Booster at 11 Months and Immunogenicity of the Booster
Status:
COMPLETED
Status Verified Date:
2016-10
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 primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals Hib-MenC conjugate vaccine when given with Infanrix penta to infants at 3 5m compared to NeisVac-C given with Infanrix hexa
The purpose of the booster vaccination phase is to evaluate the immunogenicity safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix penta at 11 m of age versus NeisVac-C given with Infanrix hexa as well as the antibody persistence prior to the administration of the booster doses The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The purpose of the booster vaccination phase is to evaluate the immunogenicity safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix penta at 11 m of age versus NeisVac-C given with Infanrix hexa as well as the antibody persistence prior to the administration of the booster doses The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
This multicenter study is open and consists of a primary and a booster phase The study has 2 treatment groups with NeisVac-C Infanrix hexa as active controls In the primary phase one blood sample will be collected from all subjects for immunogenicity analyses- one month after the second vaccination dose In the booster phase two blood samples will be collected prior to and one month post booster vaccination
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 |
|---|---|---|---|
| 106390 | OTHER | GSK | None |