Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228917
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2005-09-27
Brief Title:
Safety Study of Tritanrix-HepBHib-MenAC Tritanrix-HepBHiberix and Mencevax ACWY Vaccines in Children
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess Reactogenicity Safety of a Booster of Either Tritanrix-HepBHib-MenAC or Tritanrix-HepBHiberix Given Single-blind at 15-18 Philippines15-24 Mths Thailand a Dose of Mencevax ACWY at 24-30 Mths Open Label
Status:
COMPLETED
Status Verified Date:
2020-02
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 two stages In the diphtheria tetanus pertussis DTP booster phase subjects will receive a booster dose of Tritanrix-HepBHib-MenAC or Tritanrix-HepBHiberix active control at 15 to 18 or 24 months in a single-blind manner so that the subjects parents will not know which vaccine was administered to their child In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix-HepBHib-MenAC No blood samples will be taken in this safety study
Detailed Description:
Subjects previously primed with Tritanrix-HepBHib-MenAC will receive Tritanrix-HepBHib-MenAC or Tritanrix-HepBHiberix vaccine at 15-1824 m respectively without or with Mencevax ACWY vaccine at 24 to 30 months of age Subjects previously primed with Tritanrix-HepBHiberix will receive Tritanrix-HepBHib-MenAC or Tritanrix-HepBHiberix vaccine at 15-1824 m with Mencevax ACWY vaccine at 24 to 30 months of age
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 |
|---|---|---|---|
| 104171 | OTHER | GSK | None |