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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00697866
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 951 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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).
Study Start Date : August 2000
Primary Completion Date : February 2001

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Group A
HBV-MPL Lot A
Biological: HBV-MPL vaccine 208129
3 consecutive lots; 3-dose intramuscular injection
Experimental: Group B
HBV-MPL Lot B
Biological: HBV-MPL vaccine 208129
3 consecutive lots; 3-dose intramuscular injection
Experimental: Group C
HBV-MPL Lot C
Biological: HBV-MPL vaccine 208129
3 consecutive lots; 3-dose intramuscular injection
Active Comparator: Group D
Engerix™-B
Biological: Engerix™-B
3-dose intramuscular injection
Other Name: HBV-MPL vaccine 208129


Outcome Measures

Primary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: At month 3 ]

Secondary Outcome Measures :
  1. Anti-HBs antibody concentrations [ Time Frame: At M1, M2, M3 ]
  2. Anti-RF1 antibody titres in a subset of 50 subjects per group [ Time Frame: At months 0 and 3 ]
  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 ]
  4. Occurrence, intensity and relationship to vaccination of unsolicited symptoms [ Time Frame: Within 30 days after each vaccination ]
  5. Occurrence, intensity and relationship to vaccination of serious adverse events [ Time Frame: During the study period ]

Eligibility Criteria

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697866


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Additional Information:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 208129/037
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208129/037
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 208129/037
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208129/037
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208129/037
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208129/037
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00697866     History of Changes
Other Study ID Numbers: 208129/037
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Keywords provided by GlaxoSmithKline:
Adjuvanted hepatitis B vaccine
Hepatitis B
Recombinant hepatitis B vaccine

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs