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Immunogenicity and Safety of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Adults (15-40 Yrs).

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697216
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

This study evaluates the safety and immunogenicity of the candidate HBV-MPL vaccine administered to healthy adults aged from 15 to 40 years, according to a 0, 6- month vaccination schedule, with Engerix™-B as control administered at 0, 1, 6 months.


Condition Intervention Phase
Hepatitis B
 Biological: HBV-MPL vaccine 208129
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: Study Comparing the Immunogenicity and Reactogenicity of GSK Biologicals' HBV-MPL Vaccine Injected According to a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in a Healthy Adult Population (15-40 Years)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: Month 7 ]

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: At months 1, 2, 6, 7 and 12 ]
  • Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: 4-day follow-up period after vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: 31-day follow-up after vaccination ]
  • Occurrence and relationship to vaccination of Serious Adverse Events (SAEs) [ Time Frame: During the study period ]

Enrollment: 340
Study Start Date: March 1997
Primary Completion Date: March 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
Active Comparator: Group B Biological: Engerix™-B
3-dose intramuscular injection

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: between 15 and 40 years old.
  • Good physical condition as established by clinical examination and history taking at the time of entry.
  • Female participants who are at risk to become pregnant will be on a contraceptive programme if necessary during the study period.
  • Written informed consent obtained from the subjects aged between 18 and 40 and from the parents/tutor when the subjects are aged between 15 and 17 years.

Exclusion Criteria:

  • Positive titres at screening for anti-HBs antibodies.
  • Elevated serum liver enzymes.
  • History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
  • Any acute disease at the moment of entry.
  • Chronic alcohol consumption.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Any chronic drug treatment, including any treatment with immunosuppressive drugs, 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 participation in any other clinical trial.
  • Previous vaccination with a hepatitis B vaccine.
  • Previous vaccination with an MPL containing vaccine.
  • Administration of immunoglobulins in the past 6 months and during the whole study period
  • Simultaneous vaccination one week before and one week after each dose of the study vaccine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697216

Locations
Belgium
GSK Clinical Trials Call Center
Brussels, Belgium
Denmark
GSK Clinical Trials Call Center
Copenhagen, Denmark
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697216     History of Changes
Other Study ID Numbers: 208129/027
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by GlaxoSmithKline:
Hepatitis B
Recombinant hepatitis B vaccine
Adjuvanted hepatitis B vaccine

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

ClinicalTrials.gov processed this record on May 16, 2013