Hepatitis BPhase 3NCT00697866
Consistency of 3 Consecutive Lots of a Novel HBV Vaccine With Single-blind Safety Evaluation Using Engerix™-B as Control
A Phase 3 study testing HBV-MPL vaccine 208129 and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- HBV-MPL vaccine 208129 and Engerix™-B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 951 participants
- Where
- No sites listed yet
- Study dates
- Aug 2000to Feb 2001
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
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).
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.
Read the 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
- Conditions
- Hepatitis B
- Being tested
- HBV-MPL vaccine 208129, Engerix™-B
- Keywords
- Adjuvanted hepatitis B vaccine, Hepatitis B, Recombinant hepatitis B vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBV-MPL vaccine 208129Biological
3 consecutive lots; 3-dose intramuscular injection
Engerix™-BBiological
Also called HBV-MPL vaccine 208129
3-dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | HBV-MPL Lot A Receives: Biological: HBV-MPL vaccine 208129 |
| Group B | Experimental | HBV-MPL Lot B Receives: Biological: HBV-MPL vaccine 208129 |
| Group C | Experimental | HBV-MPL Lot C Receives: Biological: HBV-MPL vaccine 208129 |
| Group D | Active comparator | Engerix™-B Receives: Biological: Engerix™-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-HBs antibody concentrations
Measured: At month 3
Secondary outcomes (5)
Anti-HBs antibody concentrations
Measured: At M1, M2, M3
Anti-RF1 antibody titres in a subset of 50 subjects per group
Measured: At months 0 and 3
Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms
Measured: During a 4-day follow-up after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited symptoms
Measured: Within 30 days after each vaccination
Occurrence, intensity and relationship to vaccination of serious adverse events
Measured: During the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startAug 2000
- Primary completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 951 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697866
- Sponsor's protocol ID
- 208129/037
- Status last verified
- Sep 2016
- First submitted
- 12 Jun 2008
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00697866
- Acronym / sponsor ID
- 208129/037
- Conditions
- Hepatitis B
- Keywords
- Adjuvanted hepatitis B vaccine, Hepatitis B, Recombinant hepatitis B vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 951 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2000
- Primary completion
- Feb 2001 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: HBV-MPL vaccine 208129HBV-MPL Lot A |
| Group B | Experimental | Biological: HBV-MPL vaccine 208129HBV-MPL Lot B |
| Group C | Experimental | Biological: HBV-MPL vaccine 208129HBV-MPL Lot C |
| Group D | Active comparator | Biological: Engerix™-BEngerix™-B |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBV-MPL vaccine 2081293 consecutive lots; 3-dose intramuscular injection | Biological | Group A, Group B, Group C |
| Engerix™-BAlso: HBV-MPL vaccine 2081293-dose intramuscular injection | Biological | Group D |
Primary outcome
Anti-HBs antibody concentrations
Time frame: At month 3
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HBV-MPL vaccine 208129 and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-HBs antibody concentrations (time frame: At month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.