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

June 12, 2008
June 13, 2008
March 1998
May 1999   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00697775 on ClinicalTrials.gov Archive Site
  • Anti-HBs antibody concentrations [ Time Frame: At months 1, 2, 6, and 7 ]
  • Cell mediated immunity [ Time Frame: At months 1, 6, and 7 ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy Adolescents
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

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

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Hepatitis B
  • Biological: HBV-MPL vaccine Formulation A
    Single dose (when extemporaneously co-administered with Engerix™-B) or 2-dose (when administered alone) intramuscular injection
  • Biological: HBV-MPL vaccine Formulation B
    2-dose intramuscular injection
  • Biological: Engerix™-B
    Single dose (when extemporaneously co-administered with HBV-MPL) or 3-dose (when administered alone) intramuscular injection
  • Experimental: Group A
    HBV-MPL Formulation A at months 0 and 6
    Intervention: Biological: HBV-MPL vaccine Formulation A
  • Experimental: Group B
    HBV-MPL Formulation B at months 0 and 6
    Intervention: Biological: HBV-MPL vaccine Formulation B
  • Experimental: Group C
    HBV-MPL Formulation A at month 0 and Engerix™-B at month 6
    Interventions:
    • Biological: HBV-MPL vaccine Formulation A
    • Biological: Engerix™-B
  • Active Comparator: Group D
    Engerix™-B at months 0, 1, 6
    Intervention: Biological: Engerix™-B
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
Not Provided
May 1999   (final data collection date for primary outcome measure)

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
Both
11 Years to 15 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00697775
208129/028
Not Provided
Isabelle Harpigny, GSK
GlaxoSmithKline
Not Provided
Study Director: Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP