Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291343
Status:
COMPLETED
Last Update Posted:
2018-06-06
First Post:
2006-02-13
Brief Title:
Immune Response Safety of GSK Biologicals Mencevax ACWY in Subjects Primed in the DTPW-HBVHIB-MENAC-TT-011 Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Booster Vaccination Study to Assess Immunogenicity Safety of a Dose of GSK Biologicals Mencevax ACWY 15th of a Dose of Mencevax ACWY in Subjects Primed in the DTPW-HBVHIB-MENAC-TT-011 Study
Status:
COMPLETED
Status Verified Date:
2017-04
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 study will be conducted in three stages In the DTP booster stage at 15 to 24 months of age all subjects will receive a booster dose of Tritanrix-HepBHiberix In the Mencevax ACWY full dose stage at 24 to 30 months of age all subjects will receive a dose of Mencevax ACWY In the Mencevax ACWY small dose stage at 30 to 36 months of age the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax ACWY vaccine The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Subjects in the group that was previously primed with Tritanrix-HepBHiberix will be the control group for the group that was previously primed with Tritanrix-HepBHib-MenAC
Blood samples will be drawn from subjects as follows
prior to and one month after the full dose of the Mencevax ACWY vaccine
prior to and one month after 15th of a dose of Mencevax ACWY vaccine only for the first 75 subjects in each of the two centers
Blood samples will be drawn from subjects as follows
prior to and one month after the full dose of the Mencevax ACWY vaccine
prior to and one month after 15th of a dose of Mencevax ACWY vaccine only for the first 75 subjects in each of the two centers
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 |
|---|---|---|---|
| 105245 | OTHER | GSK | None |