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

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ClinicalTrials.gov Identifier: NCT00383227
Recruitment Status : Completed
First Posted : October 3, 2006
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III, Clinical Trial Comparing the Immunogenicity and Safety of SmithKline Beecham 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
Actual Primary Completion Date : November 2000
Actual Study Completion Date : November 2000

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Anti-HBs seroprotection rates at Month 7.

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, Senior)
Sexes Eligible for Study:   All
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)

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 ClinicalTrials.gov identifier (NCT number): NCT00383227


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208129/032
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208129/032
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208129/032
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208129/032
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 208129/032
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 208129/032
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00383227     History of Changes
Other Study ID Numbers: 208129/032
First Posted: October 3, 2006    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs