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Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and 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: NCT00697840
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : June 16, 2008
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Brief Summary:
The purpose of the present trial is to assess the safety, reactogenicity and immunogenicity of adjuvanted hepatitis B vaccine, Engerix™-B and hepatitis B vaccine new formulation when administered at 0, 6 months

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Engerix™-B Biological: HBV-MPL 208129 Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation 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 : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Study to Assess the Safety, Immunogenicity and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Adjuvanted Recombinant Hepatitis B Vaccine, Recombinant Hepatitis B Vaccine New Formulation and Engerix™-B
Study Start Date : June 1995
Actual Primary Completion Date : January 1996
Actual Study Completion Date : January 1996

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group A Biological: HBV-MPL 208129
Intramuscular injection, 2 doses

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

Experimental: Group C Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation
Intramuscular injection, 2 doses; experimental formulation

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: At month 7 ]
  2. Occurrence and intensity of solicited local and general symptoms [ Time Frame: 4-day follow-up after vaccination ]
  3. Occurrence of unsolicited adverse events [ Time Frame: 30-days after vaccination ]
  4. Incidence of serious adverse events [ Time Frame: Throughout the study period ]
  5. Anti-Hbs antibody concentrations [ Time Frame: Months 1, 6 and 24 ]

Information from the National Library of Medicine

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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 HBs antibody.
  • 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): NCT00697840

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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: NCT00697840     History of Changes
Other Study ID Numbers: 208129/019
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: June 16, 2008
Last Verified: June 2008
Keywords provided by GlaxoSmithKline:
Hepatitis B
Recombinant hepatitis B vaccine
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