Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317174
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2006-02-15
Brief Title:
A Study to Assess Antibody Persistence Boostability Safety in Previously Primed Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess Immune Persistence Memory by Giving Plain PRPPSA PSC 10 Mths Age Immunogenicity Safety of a Tritanrix-HBVHib-MenAC Tritanrix-HBVHib25 Booster 15-18 Mths Age in Previously Primed Subjects
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 the study is as follows
To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix-HepBHib-MenAC three formulations in the study DTPwHBHibMenACTT001 CPMS No 759346001 by giving unconjugated PRP PSA and PSC at 10 months age to one subset of subjects
To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix-HepBHib25 vaccine or Tritanrix-HepBHib-MenAC vaccine at 15-18 months age in the other subset of subjects
To evaluate the persistence of antibodies and the presence of immune memory induced by a 3-dose primary vaccination with Tritanrix-HepBHib-MenAC three formulations in the study DTPwHBHibMenACTT001 CPMS No 759346001 by giving unconjugated PRP PSA and PSC at 10 months age to one subset of subjects
To evaluate the persistence of all antibodies pertaining to primary vaccination and the booster response to Tritanrix-HepBHib25 vaccine or Tritanrix-HepBHib-MenAC vaccine at 15-18 months age in the other subset of subjects
Detailed Description:
This study will be conducted in two stages
At 10 months age half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide PS vaccine at 10 months age
At 15 to 18 months age DTP booster phase all subjects will receive a booster dose of Tritanrix-HepBHib-MenAC or Tritanrix-HepBHib25
At 10 months age half of the subjects will receive a dose of plain meningococcal AC and PRP polysaccharide PS vaccine at 10 months age
At 15 to 18 months age DTP booster phase all subjects will receive a booster dose of Tritanrix-HepBHib-MenAC or Tritanrix-HepBHib25
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