Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
Primary Purpose
Hepatitis B
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
HBV-MPL vaccine 208129
Engerix™-B
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis B focused on measuring Adjuvanted hepatitis B vaccine, Hepatitis B, Recombinant hepatitis B vaccine
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Group A
Group B
Group C
Group D
Arm Description
HBV-MPL Lot A
HBV-MPL Lot B
HBV-MPL Lot C
Engerix™-B
Outcomes
Primary Outcome Measures
Anti-HBs antibody concentrations
Secondary Outcome Measures
Anti-HBs antibody concentrations
Anti-RF1 antibody titres in a subset of 50 subjects per group
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Occurrence, intensity and relationship to vaccination of serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00697866
Brief Title
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
August 2000 (undefined)
Primary Completion Date
February 2001 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Adjuvanted hepatitis B vaccine, Hepatitis B, Recombinant hepatitis B vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
951 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
HBV-MPL Lot A
Arm Title
Group B
Arm Type
Experimental
Arm Description
HBV-MPL Lot B
Arm Title
Group C
Arm Type
Experimental
Arm Description
HBV-MPL Lot C
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Engerix™-B
Intervention Type
Biological
Intervention Name(s)
HBV-MPL vaccine 208129
Intervention Description
3 consecutive lots; 3-dose intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Engerix™-B
Other Intervention Name(s)
HBV-MPL vaccine 208129
Intervention Description
3-dose intramuscular injection
Primary Outcome Measure Information:
Title
Anti-HBs antibody concentrations
Time Frame
At month 3
Secondary Outcome Measure Information:
Title
Anti-HBs antibody concentrations
Time Frame
At M1, M2, M3
Title
Anti-RF1 antibody titres in a subset of 50 subjects per group
Time Frame
At months 0 and 3
Title
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Time Frame
During a 4-day follow-up after vaccination
Title
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Time Frame
Within 30 days after each vaccination
Title
Occurrence, intensity and relationship to vaccination of serious adverse events
Time Frame
During the study period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/037
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/037
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/037
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/037
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/037
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
208129/037
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
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