Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 2, 2006
Last updated: September 29, 2011
Last verified: September 2011

Persistence of anti-HBs antibodies at Month 24, 30 and 36 in subjects who had completed primary vaccination was evaluated. The anamnestic response to a booster dose was evaluated in subjects with anti-HBs antibody titres < 10 mIU/ml at previous timepoint. The study also evaluated the effect of a booster dose of the vaccine (Month 42) after primary vaccination.

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: A Phase III, Clinical Trial Comparing the Persistence of GSK Biologicals New Adjuvanted Hepatitis B Vaccine to a Double Dose of Engerix™-B at Months 24, 30, 36, in Pre-haemodialysis/Haemodialysis Patients (≥15 Years of Age)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs seroprotection
  • Response to booster

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

Estimated Enrollment: 120
Study Start Date: March 2002
Intervention Details:
    Biological: Hepatitis B adjuvanted vaccine Biological: Engerix-B
    Other Names:
    • Hepatitis B adjuvanted vaccine
    • Engerix-B

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

Inclusion Criteria:

  • Subjects were to have completed primary vaccination course. 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.
  • If the subject was a female, she was of non-childbearing potential or, if of childbearing potential, she was to be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Pregnant or lactating female.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00383591

Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
GSK Investigational Site
Bandar Tun Razak, Cheras, Malaysia, 56000
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Malaga, Spain, 29010
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00383591     History of Changes
Other Study ID Numbers: 208129/047
Study First Received: October 2, 2006
Last Updated: September 29, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 25, 2014