Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136604
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2005-08-26
Brief Title:
Response to GSK Biologicals Tritanrix-HepBHib-MenAC Vacc 4th Dose at 15-24m Mencevax ACWY at 24-30m
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess Immunogenicity Safety Reactogenicity of a 4th Dose of GSK Biologicals Tritanrix-HepBHib-MenAC at 15-24 m of a Dose of Mencevax ACWY at 24-30 m in Subjects Primed With 3 Doses of Tritanrix-HepBHib-MenAC
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:
The purpose of the study is to evaluate the immunogenicity safety and reactogenicity of a booster dose of DTPw-HBVHib-MenAC compared to DTPw-HBVHib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepBHib-MenAC in study 100480 Antibody persistence will be evaluated at 24 to 30 months Immunogenicity safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate andor MenC containing vaccine
Detailed Description:
This study will be conducted in two stages In the DTP booster phase subjects will receive a booster dose of Tritanrix-HepBHib-MenAC or Tritanrix-HepBHib active control at 15 to 24 months in a single-blind manner so that the subjects parents will not know which vaccine was administered to their child this booster phase is no longer recruiting In the Mencevax ACWY phase at 24-30 months a dose of Mencevax ACWY will be given to subjects who were not boosted with a MenA conjugate andor MenC containing vaccine at 15-24 months in an open manner this booster phase is not yet recruiting Up to four blood samples will be taken before and one month after the administration of the DTP booster dose and of Mencevax ACWY To comply with the immunisation calender of Thailand at 15-24 months all subjects will receive OPV At 16-25 months 2 doses of Japanese Encephalitis JE vaccine or a dose of varicella vaccine will be offered and at 25-31 months a dose of varicella or JE vaccine will be offered
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 |
|---|---|---|---|
| 104730 | None | None | None |