Hepatitis BPhase 3NCT00697242
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults
A Phase 3 study testing Engerix™-B and Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL in people with Hepatitis B, run by GlaxoSmithKline at 4 sites in 4 countries.
Trial summary
In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix™-B and Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 362 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jan 1994to Nov 1995
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects between 50 and 70 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry
Who cannot join
- Positive titres for anti hepatitis antibodies
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL
- Elevated serum liver enzymes at two subsequent determinations 14 days apart.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
- Axillary temperature > 37.5°C at the time of injection.
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- Any acute disease at the moment of entry.
- Chronic alcohol consumption.
- Any treatment with immunosuppressive or immunostimulant therapy.
- Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
- History of allergic disease likely to be stimulated by any component of the vaccine.
- Administration of any other vaccine(s) or any immunoglobulin during the study period.
- Simultaneous participation in any other clinical trial.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers
In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
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
- Engerix™-B, Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL
- Keywords
- Hepatitis B, Engerix™-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.
Engerix™-BBiological
Intramuscular injection, 3 doses
Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPLBiological
Intramuscular injection, 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Group B | Experimental | Not described Receives: Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Group C | Experimental | Not described Receives: Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Group D | Active comparator | Not described Receives: Biological: Engerix™-B |
| Group E | Experimental | Not described Receives: Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Measured: At M2 and M7
Secondary outcomes (6)
Anti-pre-S1 antibody concentrations
Measured: Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Anti-HBs antibody concentrations
Measured: Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms
Measured: 4-day after vaccination
Cell mediated immunity
Measured: Month 0, Month 2 and month 7
Occurrence of unsolicited adverse events
Measured: 30 days after vaccination
Occurrence of serious adverse events
Measured: During the study period and 30 days after last vaccine dose
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 startJan 1994
- Primary completionNov 1995
- Study completionNov 1995
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 362 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
- NCT00697242
- Sponsor's protocol ID
- 208129/009
- 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
- Study to Compare the Immunogenicity, Safety and Reactogenicity of GSK Biologicals' (Previously SmithKline Beecham Biologicals') Recombinant Hepatitis B Vaccines With and Without Adjuvant in Healthy Older Adult Volunteers
- ClinicalTrials.gov ID
- NCT00697242
- Acronym / sponsor ID
- 208129/009
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Engerix™-B, Recombinant Hepatitis B vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 1994
- Primary completion
- Nov 1995 (actual)
- Study completion
- Nov 1995 (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.
In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects
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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Group B | Experimental | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Group C | Experimental | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
| Group D | Active comparator | Biological: Engerix™-B |
| Group E | Experimental | Biological: Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male or female subjects between 50 and 70 years old.
- Written informed consent will have been obtained from the subjects.
- Good physical condition as established by physical examination and history taking at the time of entry
Key exclusion criteria (13 listed)
- Positive titres for anti hepatitis antibodies
- Any vaccination against hepatitis B in the past.
- Any previous administration of MPL
- Elevated serum liver enzymes at two subsequent determinations 14 days apart.
- History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
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 |
|---|---|---|
| Engerix™-BIntramuscular injection, 3 doses | Biological | Group D |
| Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPLIntramuscular injection, 3 doses | Biological | Group A, Group B, Group C, Group E |
Primary outcome
Anti-hepatitis B surface antigen (HBs) antibody concentrations
Time frame: At M2 and M7
6 secondary outcomes
Anti-pre-S1 antibody concentrations
Time frame: Screening, Months 1, 2, 3, 6, 7, 8 and 12, depending on group allocation
Anti-HBs antibody concentrations
Time frame: Screening, Months 1, 2, 3, 6, 7, 8 and 12
Occurrence and intensity of local and general solicited symptoms
Time frame: 4-day after vaccination
Cell mediated immunity
Time frame: Month 0, Month 2 and month 7
Occurrence of unsolicited adverse events
Time frame: 30 days after vaccination
Occurrence of serious adverse events
Time frame: During the study period and 30 days after last vaccine dose
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.
Related trials for Hepatitis B
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Chronic Hepatitis B
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
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Engerix™-B and Recombinant HBsAg with different concentrations of Aluminium Salts and/or MPL in people with Hepatitis B, run by GlaxoSmithKline at 4 sites in 4 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 3 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 4 sites in Austria, Belgium, Denmark, Iceland. 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?
Anti-hepatitis B surface antigen (HBs) antibody concentrations (time frame: At M2 and M7). 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.