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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383383
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : October 3, 2006
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Brief Summary:
Comparison of adjuvanted hepatitis B vaccine to double dose of Engerix™-B in pre- /haemodialysis patients aged ≥15 years.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Hepatitis B adjuvanted vaccine Biological: Engerix-B Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : December 1999

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383383

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

Layout table for additonal information Identifier: NCT00383383     History of Changes
Other Study ID Numbers: 208129/042
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: October 3, 2006
Last Verified: October 2006
Additional relevant MeSH terms:
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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
Immunologic Factors
Physiological Effects of Drugs