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Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control

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ClinicalTrials.gov Identifier: NCT00697866
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE June 12, 2008
First Posted Date  ICMJE June 16, 2008
Last Update Posted Date September 16, 2016
Study Start Date  ICMJE August 2000
Actual Primary Completion Date February 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
Anti-HBs antibody concentrations [ Time Frame: At month 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00697866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
  • Anti-HBs antibody concentrations [ Time Frame: At M1, M2, M3 ]
  • Anti-RF1 antibody titres in a subset of 50 subjects per group [ Time Frame: At months 0 and 3 ]
  • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 4-day follow-up after vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of serious adverse events [ Time Frame: During the study period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
Official Title  ICMJE Evaluating the Consistency of 3 Consecutive Lots of GSK Biologicals' Novel Adjuvanted HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as a Control, Administered According to a 0, 1, 2-month Schedule in Healthy Volunteers (15-50y).
Brief Summary The purpose of the present study is to evaluate the immunogenicity and safety of three consecutive production lots of the novel adjuvanted HBV vaccine. The safety of the candidate vaccine will be assessed using Engerix™-B as control.
Detailed Description

Double-blind for the identity of the consistency lots, single-blind for the control group/study vaccine identity.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • Biological: HBV-MPL vaccine 208129
    3 consecutive lots; 3-dose intramuscular injection
  • Biological: Engerix™-B
    3-dose intramuscular injection
    Other Name: HBV-MPL vaccine 208129
Study Arms  ICMJE
  • Experimental: Group A
    HBV-MPL Lot A
    Intervention: Biological: HBV-MPL vaccine 208129
  • Experimental: Group B
    HBV-MPL Lot B
    Intervention: Biological: HBV-MPL vaccine 208129
  • Experimental: Group C
    HBV-MPL Lot C
    Intervention: Biological: HBV-MPL vaccine 208129
  • Active Comparator: Group D
    Engerix™-B
    Intervention: Biological: Engerix™-B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2008)
951
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A male or female between, and including, 15 and 50 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject/ from the parents or guardians of the subject where applicable
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days 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) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Planned administration/Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s).
  • Previous vaccination against hepatitis B
  • History of non-response to previous hepatitis B vaccination
  • Known exposure to hepatitis B within the previous 6 weeks
  • History of hepatitis B infection
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • A family history of congenital or hereditary immunodeficiency.
  • Suspected or confirmed multiple sclerosis in the subject (applicable to Centre 5/France only)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Hepatomegaly, right upper quadrant abdominal pain or tenderness.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Belgium,   Czech Republic,   France,   Italy,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT00697866
Other Study ID Numbers  ICMJE 208129/037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2016

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