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Safety, Immunogenicity and Reactogenicity of Recombinant Hepatitis B Vaccine (Adjuvanted & New Formulation) and Engerix™-B

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00697840
First Posted: June 16, 2008
Last Update Posted: June 16, 2008
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.
Information provided by:
GlaxoSmithKline
  Purpose
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 Intervention Phase
Hepatitis B Biological: Engerix™-B Biological: HBV-MPL 208129 Biological: Vaccine containing HBsAg absorbed on aluminium salts - experimental formulation Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Enrollment: 150
Study Start Date: June 1995
Study Completion Date: January 1996
Primary Completion Date: January 1996 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Criteria

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.
  Contacts and Locations
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): NCT00697840


Locations
Austria
GSK Clinical Trials Call Center
Vienna, Austria
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697840     History of Changes
Other Study ID Numbers: 208129/019
First Submitted: June 12, 2008
First Posted: June 16, 2008
Last Update Posted: June 16, 2008
Last Verified: June 2008

Keywords provided by GlaxoSmithKline:
Hepatitis B
Engerix™-B
Recombinant hepatitis B vaccine
Adjuvant

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