Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197249
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2005-09-15
Brief Title:
Comparative Study in Healthy Adults Aged 18-50 Yrs Administered With Hepatyrix or HavrixTypherix or Tiphim Vi to Compare Reactogenicity Immunogenicity
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Open Randomized Multicentric Study to Compare the Reactogenicity and Immunogenicity of GSK Biologicals Combined Vi Polysaccharide Typhoid Vaccine and Inactivated Hepatitis A Vaccine to That Elicited by GSK Biologicals Hepatitis A Vaccine Administered Singly or Concomitantly With GSK Biologicals Vi Polysaccharide Vaccine
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:
To evaluate the immunogenicity reactogenicity and safety of Hepatyrix when compared to the concomitant administration of Typherix and Havrix and when compared to the administration of monovalent vaccines Havrix or Typhim Vi Furthermore the study will evaluate the persistence of anti-Vi and anti-HAV antibodies up to 36 months after administration of the first dose of the study vaccine
Detailed Description:
Compare the reactogenicity immunogenicity of GSK Biologicals combined Vi polysaccharide typhoid vaccine inactivated hepatitis A vaccine Hepatyrix to that elicited by GSK Biologicals hepatitis A vaccine Havrix administered singly or concomitantly with GSK Biologicals Vi polysaccharide vaccine Typherix to that elicited by Aventis Pasteurs monovalent Vi polysaccharide vaccine Typhim Vi administered intramuscularly to healthy subjects aged 18-65 yrs
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 |
|---|---|---|---|
| 270362009 Ext Mth36 | OTHER | GSK | None |
| 270362007 Ext Mth12 | OTHER | None | None |
| 270362008 Ext Mth24 | OTHER | None | None |