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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00197249 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis B Typhoid Hepatitis A |
Biological: Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Phase III, Open, Randomized, Multicentric Study to Compare the Reactogenicity and Immunogenicity of GSK Bios' Combined Vi Polysaccharide Typhoid Vac and Inactivated Hepatitis A Vac, to That Elicited by GSK Bios' Hepatitis A Vac, Admin Singly or Concomitantly With GSK Bios' Vi Polysaccharide Vac |
| Enrollment: | 1034 |
| Study Start Date: | May 2002 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
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 Pasteur's monovalent Vi polysaccharide vaccine, Typhim Vi, administered intramuscularly to healthy subjects aged 18-65 yrs.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion criteria
Exclusion criteria
Contacts and Locations
More Information
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00197249 History of Changes |
| Other Study ID Numbers: | 270362/006, 270362/007 (Ext. Mth12), 270362/008 (Ext. Mth24), 270362/009 (Ext. Mth36) |
| Study First Received: | September 15, 2005 |
| Last Updated: | November 17, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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Hepatitis A & B Typhoid |
|
Hepatitis Hepatitis A Hepatitis B Typhoid Fever Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Salmonella Infections Enterobacteriaceae Infections Gram-Negative Bacterial Infections Bacterial Infections |