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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00197249 |
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 |
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Typhoid Hepatitis A Hepatitis B |
Biological: Combined Vi polysaccharide typhoid vaccine and hepatitis A vaccine- Hepatyrix |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 952 |
Open, randomised, self-contained, multicentric, multinational study. The three comparators in this study are Havrix, Typherix, Typhim Vi. In the primary phase, subjects included in Hepatyrix at Day 0 and Havrix at Month 6; subjects included in Havrix+Typherix Group having received concomitantly Havrix and Typherix at Day 0 and Havrix at Month 6; subjects included in the Havrix Group having received Havrix at Day 0 and Month 6 and on a voluntary basis, a single dose of Typherix at Month 7; subjects included in the Typhim Vi Group having received Typhim Vi at Day 0. Subjects randomized to receive Typhim Vi at Day 0 were given on a voluntary basis and at the discretion of the investigator, the first dose of Havrix at Month 6 and the second Havrix dose at Month 12 follow-up visit. The long-term follow-up studies at approximately 12, 24 and 36 months after the primary vaccination of Vi typhoid vaccine involves taking a blood sample to assess antibody persistence and a retrospective safety follow-up.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria
Exclusion criteria
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: | October 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00197249 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Typhoid Hepatitis A & B |
Bacterial Infections Liver Diseases Enterobacteriaceae Infections Salmonella Infections Hepatitis, Viral, Human Picornaviridae Infections Healthy Typhoid Fever Gram-Negative Bacterial Infections |
Hepatitis Fever Virus Diseases Digestive System Diseases Typhoid Hepatitis B Hepatitis A DNA Virus Infections Enterovirus Infections |
Bacterial Infections Liver Diseases RNA Virus Infections Enterobacteriaceae Infections Salmonella Infections Hepatitis, Viral, Human Picornaviridae Infections Typhoid Fever Hepadnaviridae Infections |
Gram-Negative Bacterial Infections Hepatitis Virus Diseases Digestive System Diseases Hepatitis B Hepatitis A DNA Virus Infections Enterovirus Infections |