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Evaluation of Immunogenicity and Reactogenicity of Various Formulations of Recombinant Hepatitis B Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697970
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of the present trial is to evaluate 6 vaccine formulations of recombinant hepatitis B vaccine for their reactogenicity and immunogenicity when administered at 0-2 months with a booster at month 12


Condition Intervention Phase
Hepatitis B
 Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Biological: Engerix™-B
 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 Evaluate the Immunogenicity and Reactogenicity of Various Formulations of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccine in Healthy Adult Volunteers

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: After two doses and after the booster dose ]

Secondary Outcome Measures:
  • Occurrence and intensity of local and general solicited symptoms [ Time Frame: 8 days after vaccination ]
  • Anti-HBs antibody concentrations [ Time Frame: Screening, M1, 2, 3, 4, 6, 12, 13 ]
  • Occurrence of unsolicited adverse events [ Time Frame: 30-day after vaccination ]
  • Occurrence of serious adverse events [ Time Frame: During the study period and 30 days after the last vaccination ]

Enrollment: 321
Study Start Date: November 1993
Study Completion Date: April 1995
Primary Completion Date: April 1995 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group B Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group C Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group D Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Experimental: Group E Biological: HBsAg formulated with different concentrations of MPL and Aluminium Salts
Intramuscular injection, 3 doses
Active Comparator: Group F Biological: Engerix™-B
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:   18 Years to 40 Years
Genders Eligible for Study:   Both
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.
  • Positivity for anti hepatitis 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.
  • Administration of any other vaccine(s) or any immunoglobulin during the study period.
  • Simultaneous participation in any other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697970

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697970     History of Changes
Other Study ID Numbers: 208129/006
Study First Received: June 12, 2008
Last Updated: June 13, 2008
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013