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
  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:


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
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: 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
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014