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Trial record 4 of 24 for:    engerix-b gsk | Hepatitis B | Phase 3

Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

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: NCT00698087
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : June 16, 2008
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Brief Summary:
The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: MPL-Adjuvanted recombinant hepatitis B vaccine Biological: Engerix™-B Phase 3

Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Study to Compare the Safety, Immunogenicity and Reactogenicity of Different Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Study Start Date : January 1995
Actual Primary Completion Date : February 1996
Actual Study Completion Date : February 1996

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group A Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Intramuscular injection, 2 or 3 doses, 2 different formulations

Active Comparator: Group B Biological: Engerix™-B
Intramuscular injection, 2 or 3 doses

Experimental: Group C Biological: MPL-Adjuvanted recombinant hepatitis B vaccine
Intramuscular injection, 2 or 3 doses, 2 different formulations

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: At M3 and M13 ]
  2. Occurrence of local and general solicited symptoms [ Time Frame: 4-day follow-up after vaccination ]
  3. Occurrence of unsolicited symptoms [ Time Frame: 30-day follow-up after vaccination ]

Secondary Outcome Measures :
  1. SAEs [ Time Frame: Throughout the study up to 30 days after last vaccination ]
  2. Anti-HBs antibody concentrations [ Time Frame: Months 2, 3, 6, 9, 12, 13 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Between 18 and 40 years old.
  • Written informed consent will have been obtained from the subjects.
  • Good physical condition as established by physical examination and history taking at the time of entry.
  • Female participants will avoid becoming pregnant during the study period and they will have been on a contraceptive program for at least 2 months before entry

Exclusion Criteria:

  • Pregnancy or lactation.
  • Positive titres for anti hepatitis B antibodies
  • Any vaccination against hepatitis B in the past.
  • Any previous administration of MPL.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Axillary temperature > 37.5°C at the time of injection.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Any treatment with immunosuppressive or immunostimulant therapy.
  • Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
  • History of allergic disease likely to be stimulated by any component of the vaccine.
  • Simultaneous administration of any other vaccine(s).
  • Administration of any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial

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): NCT00698087

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GSK Clinical Trials Call Center
Vienna, Austria
Sponsors and Collaborators
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Study Director: Clinical Trials GlaxoSmithKline
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Responsible Party: Isabelle Harpigny, GSK Identifier: NCT00698087    
Other Study ID Numbers: 208129/016
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: June 16, 2008
Last Verified: June 2008
Keywords provided by GlaxoSmithKline:
Hepatitis B
Adjuvanted recombinant hepatitis B vaccine
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections