Hepatitis BPhase 3NCT00696917
Safety and Immunogenicity of 3 Lots of GSK Biologicals' HBV-MPL Vaccine and Engerix™-B in Healthy Volunteers ≥ 15y
A Phase 3 study testing HBV-MPL vaccine 208129 and Engerix™-B in people with Hepatitis B, run by GlaxoSmithKline at 7 sites in 7 countries.
Trial summary
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy 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
- 1,303 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Apr 1999to Feb 2000
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
- If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
Who cannot join
- 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.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of non-response to previous hepatitis B vaccination.
- Known exposure to hepatitis B within the past 6 weeks.
- History of hepatitis B infection.
Show all 13Show fewer
- Confirmed human immunodeficiency virus (HIV) infection.
- A family history of congenital or hereditary immunodeficiency.
- 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.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
- Pregnant or lactating female
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
Read the detailed description
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
- Hepatitis B, Adjuvanted Hepatitis B vaccine, 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
2-dose intramuscular injection 3 different vaccine lots
Engerix™-BBiological
3-dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Three doses according to 0, 1, 6-month schedule Receives: Biological: Engerix™-B |
| Group B | Experimental | Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 Receives: Biological: HBV-MPL vaccine 208129 |
| Group C | Experimental | Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 Receives: Biological: HBV-MPL vaccine 208129 |
| Group D | Experimental | Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 Receives: Biological: HBV-MPL vaccine 208129 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Measured: Full course of vaccination
Incidence of serious adverse events
Measured: Study period
Anti-HBs antibody concentrations
Measured: At Month 7
Secondary outcomes (5)
Occurrence and intensity of solicited local signs and symptoms
Measured: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
Measured: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Measured: 30 days after vaccination
Occurrence and relationship to vaccination of SAEs
Measured: During the study period
Anti-HBs antibody concentrations
Measured: At Months 1, 2, 6 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2008 (estimated)
- Study startApr 1999
- Primary completionFeb 2000
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
- 1,303 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00696917
- Sponsor's protocol ID
- 208129/031
- Status last verified
- Jun 2008
- First submitted
- 11 Jun 2008
- Last updated
- 13 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of 3 Lots of GSK Biologicals' Novel Adjuvanted Hepatitis B Vaccine, Administered According to a 2 Dose Schedule, and Engerix™-B Administered According to a 3 Dose Schedule to Healthy Volunteers ≥ 15 Years of Age
- ClinicalTrials.gov ID
- NCT00696917
- Acronym / sponsor ID
- 208129/031
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Adjuvanted Hepatitis B vaccine, Recombinant Hepatitis B vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,303 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Feb 2000 (actual)
- First posted
- 13 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.
This study was conducted to evaluate the lot-to-lot consistency of three lots of HBV-MPL vaccine and to compare their safety and immunogenicity with that of Engerix™-B.
Detailed description
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 | Active comparator | Biological: Engerix™-BThree doses according to 0, 1, 6-month schedule |
| Group B | Experimental | Biological: HBV-MPL vaccine 208129Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 |
| Group C | Experimental | Biological: HBV-MPL vaccine 208129Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 |
| Group D | Experimental | Biological: HBV-MPL vaccine 208129Two doses according to 0, 6-month schedule, with a placebo injection at Month 1 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A male or female aged ≥ 15 years at the time of the first vaccination. In Centre 103 (Germany) and Centre 1 (Netherlands), only subjects ≥ 18 years will be enrolled.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Written informed consent obtained from the subject and/or from the parent or guardian of the subject.
- If the subject was a female, she was of non-childbearing potential, if of childbearing potential, she was abstinent or used adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination
Key exclusion criteria (13 listed)
- 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.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
- Previous vaccination against hepatitis B.
- History of non-response to previous hepatitis B vaccination.
- Known exposure to hepatitis B within the past 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 2081292-dose intramuscular injection 3 different vaccine lots | Biological | Group B, Group C, Group D |
| Engerix™-B3-dose intramuscular injection | Biological | Group A |
Primary outcome
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms
Time frame: Full course of vaccination
Incidence of serious adverse events
Time frame: Study period
Anti-HBs antibody concentrations
Time frame: At Month 7
5 secondary outcomes
Occurrence and intensity of solicited local signs and symptoms
Time frame: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of solicited general signs and symptoms
Time frame: 4-day after vaccination
Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms
Time frame: 30 days after vaccination
Occurrence and relationship to vaccination of SAEs
Time frame: During the study period
Anti-HBs antibody concentrations
Time frame: At Months 1, 2, 6 and 7
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 13 Jun 2008.
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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.
Clinical Trials study director
GlaxoSmithKline
7 sites in 7 countries: see every site and its status.
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 at 7 sites in 7 countries.
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 13 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 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, Czechia, Germany, Italy, Netherlands and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Occurrence, intensity and causal relationship of any (solicited/unsolicited adverse event) general symptoms (time frame: Full course of vaccination). The study lists 3 primary outcomes in all. 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 13 Jun 2008.