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Comparison of Adjuvanted Hepatitis B Vaccine to Double Dose of Engerix™-B in Pre- /Haemodialysis Patients Aged ≥15 Years

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00383383
First received: October 2, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.


Condition Intervention Phase
Hepatitis B
 Biological: Hepatitis B adjuvanted vaccine
Biological: Engerix-B
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: To Compare the Immunogenicity & Safety of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B, in Pre-Haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs seroprotection rates at Month 12.

Secondary Outcome Measures:
  • Solicited symptoms, unsolicited symptoms and serious adverse events

Estimated Enrollment: 141
Study Start Date: December 1999
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A male or female > = 15 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject/ from the parents or guardians of the subject.
  • Seronegative for anti-HBs antibodies, anti-HBc antibodies & Hepatitis B Surface antigen (HBsAg).
  • If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she had to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
  • Pre-haemodialysis patient* or a patient on haemodialysis.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine during the study period or within 30 days preceding the first dose of study vaccine.
  • Previous vaccination against hepatitis B.
  • History of hepatitis B infection.
  • Known exposure to hepatitis B virus within 6 weeks. Pregnant or lactating female
  • Clinically abnormal ALT/AST values (> 3 times normal values)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383383

Locations
Czech Republic
GSK Clinical Trials Call Center
Hradec, Králové, Czech Republic
Malaysia
GSK Clinical Trials Call Center
Kuala Lumpur, Malaysia
Spain
GSK Clinical Trials Call Center
Malaga, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00383383     History of Changes
Other Study ID Numbers: 208129/042
Study First Received: October 2, 2006
Last Updated: October 2, 2006
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 23, 2013