Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322335
Status:
COMPLETED
Last Update Posted:
2016-10-20
First Post:
2006-05-04
Brief Title:
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals Hib-MenC
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Phase III Open Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals Hib-MenC Compared to a Booster Dose of Infanrix Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 Boosted in Study Hib-MenC-TT-010 BST DTPa-HBV-IPV-097
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:
This protocol posting deals with objectives outcome measures of the extension phase at Months 18 30 42 54 and 66 post booster The objectives outcome measures of the primary phase are presented in a separate protocol posting NCT number NCT00352963 The objectives outcome measures of the Booster phasestudy are presented in a separate protocol posting NCT number NCT00323050
The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 55 years after booster vaccination The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 55 years after booster vaccination The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
This multicenter study is open No vaccine will be administered during this persistence phase of the study The subjects were randomized in the primary vaccination study 217744097 DTPa-HBV-IPV-097 and will not be further randomized in this study The study has 3 groups with Meningitec primed group as control The protocol was amended to allow for enrollment of subjects of the Meningitec primed control group who were boosted with Meningitec after the end of the booster study as per new local reccommendation in Spain
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 |
|---|---|---|---|
| 106680 | OTHER | GSK | None |
| 106673 | OTHER | None | None |
| 106675 | OTHER | None | None |
| 106679 | OTHER | None | None |