Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697242
First received: June 11, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  Purpose

In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B
Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-hepatitis B surface antigen (HBs) antibody concentrations [ Time Frame: At M2 and M7 ]

Secondary Outcome Measures:
  • Anti-pre-S1 antibody concentrations [ Time Frame: Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation ]
  • Anti-HBs antibody concentrations [ Time Frame: Screening, Months 1, 2, 3, 6, 7, 8 and 12 ]
  • Occurrence and intensity of local and general solicited symptoms [ Time Frame: 4-day after vaccination ]
  • Cell mediated immunity [ Time Frame: Month 0, Month 2 and month 7 ]
  • Occurrence of unsolicited adverse events [ Time Frame: 30 days after vaccination ]
  • Occurrence of serious adverse events [ Time Frame: During the study period and 30 days after last vaccine dose ]

Enrollment: 362
Study Start Date: January 1994
Study Completion Date: November 1995
Primary Completion Date: November 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intramuscular injection, 3 doses
Experimental: Group B Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intramuscular injection, 3 doses
Experimental: Group C Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intramuscular injection, 3 doses
Active Comparator: Group D Biological: Engerix™-B
Intramuscular injection, 3 doses
Experimental: Group E Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
Intramuscular injection, 3 doses

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:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female subjects between 50 and 70 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

Exclusion Criteria:

  • Positive titres for anti hepatitis antibodies
  • Any vaccination against hepatitis B in the past.
  • Any previous administration of MPL
  • Elevated serum liver enzymes at two subsequent determinations 14 days apart.
  • 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.
  • Administration of any other vaccine(s) or any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial.
  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 ClinicalTrials.gov identifier: NCT00697242

Locations
Austria
GSK Clinical Trials Call Center
Wien, Austria
Belgium
GSK Clinical Trials Call Center
Gent, Belgium
Denmark
GSK Clinical Trials Call Center
Hvidovre, Denmark
Iceland
GSK Clinical Trials Call Center
Reykjavik, Iceland
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697242     History of Changes
Other Study ID Numbers: 208129/009
Study First Received: June 11, 2008
Last Updated: June 11, 2008
Health Authority: Belgium: Institutional Review Board
Denmark: National Board of Health
Austria: Ethikkommission
Ireland: Ministry of Health

Keywords provided by GlaxoSmithKline:
Hepatitis B
Engerix™-B
Recombinant 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 September 22, 2014