Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00697775
First received: June 12, 2008
Last updated: June 13, 2008
Last verified: June 2008
  Purpose

In this study the safety and immunogenicity of 2 different formulations of the candidate HBV-MPL vaccine administered according to a 0, 6-month schedule were explored and compared to that of Engerix™-B in healthy adolescents aged 11 to 15


Condition Intervention Phase
Hepatitis B
Biological: HBV-MPL vaccine Formulation A
Biological: HBV-MPL vaccine Formulation B
Biological: Engerix™-B
Phase 2

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 to Assess the Feasibility of GSK Bio's Candidate HBV / MPL Vaccines Following Different Schedules and Formulations and to Compare Their Safety and Immunogenicity to That of Engerix™-B in Healthy Adolescents Aged 11 to 15

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of Serious adverse experiences (SAE) [ Time Frame: During the study period ]
  • Occurrence, intensity and relationship to vaccination of solicited local and general symptoms [ Time Frame: During the 8-day follow-up period after vaccination ]
  • Occurrence, intensity and causal relationship of unsolicited adverse events [ Time Frame: 31-day follow-up period after vaccination ]

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: At months 1, 2, 6, and 7 ]
  • Cell mediated immunity [ Time Frame: At months 1, 6, and 7 ]

Enrollment: 200
Study Start Date: March 1998
Primary Completion Date: May 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
HBV-MPL Formulation A at months 0 and 6
Biological: HBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
Experimental: Group B
HBV-MPL Formulation B at months 0 and 6
Biological: HBV-MPL vaccine Formulation B
2-dose intramuscular injection
Experimental: Group C
HBV-MPL Formulation A at month 0 and Engerix™-B at month 6
Biological: HBV-MPL vaccine Formulation A
Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
Biological: Engerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
Active Comparator: Group D
Engerix™-B at months 0, 1, 6
Biological: Engerix™-B
Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) 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:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age: between 11 and 15 years at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject and from the subject himself/herself in all subjects 15 years of age.
  • If the subject is female, she must be of non-childbearing potential, if of childbearing potential, she must be abstinent or have used an adequate contraceptive for one month prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination.
  • Planned administration of a vaccine not foreseen by the study protocol during the period starting from one week before each dose of vaccine and ending 30 days after.
  • Previous vaccination against hepatitis B virus.
  • Previous vaccination with vaccine containing MPL.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrollment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Axillary temperature of ≥ 37.5° C.
  • Administration of immunoglobulin and / or any blood product within the six months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic disease deemed by the investigator to be relevant.
  • Positive for anti-HBV antibodies at screening
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00697775

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

No publications provided

Responsible Party: Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier: NCT00697775     History of Changes
Other Study ID Numbers: 208129/028
Study First Received: June 12, 2008
Last Updated: June 13, 2008
Health Authority: Germany: Ministry of Health

Keywords provided by GlaxoSmithKline:
Hepatitis 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 April 16, 2014