Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258700
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-11-24
Brief Title:
Primary Booster Immunogenicity Study of GSK Biologicals Hib-MenC Versus a Licensed Men-C Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Demonstrate Non-inferiority of Men-C Immune Response of Hib-MenC With Infanrix-IPV Versus a Licensed Men-C Vaccine With Pediacel When Given at 2 3 4 Months and the Immunogenicity of Hib-MenC When Given as a Booster Dose at 12-15 Months
Status:
COMPLETED
Status Verified Date:
2016-09
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 demonstrate the non-inferiority of the candidate Hib-MenC conjugate vaccine co-administered with Infanrix-IPV versus a licensed meningococcal serogroup C vaccine co-administered with Pediacel when given according to a 2 3 4 month schedule and the immunogenicity of the Hib-MenC vaccine when given as a booster dose at 12-15 months of age
Detailed Description:
This multicenter study is open with respect to the treatment allocation but double-blind with respect to the Hib-MenC-TT lots 3 lots The study will be conducted in two stages Primary vaccination phase 3 doses Hib-MenC-TT with Infanrix-IPV or for the control group a licensed Men-C vaccine with Pediacel at 2 3 4 months of age Boosterpersistence phase 1 dose Hib-MenC with Priorix 4 blood samples of 35ml 5ml for the UK subset are collected Study Months 0 3 prior to 42 days after the booster
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 |
|---|---|---|---|
| 104056 | OTHER | GSK | None |