Hepatitis BPhase 3NCT00289744
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
A Phase 3 study testing TWINRIX™ ADULT and Engerix TM in people with Hepatitis B and Hepatitis A, run by GlaxoSmithKline at 1 site in Belgium.
Trial summary
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatitis A
- What is being tested?
- TWINRIX™ ADULT and Engerix TM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Feb 2004to 15 Apr 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
- Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.
This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
- Conditions
- Hepatitis B, Hepatitis A
- Being tested
- TWINRIX™ ADULT, Engerix TM
- Keywords
- Hepatitis A, Hepatitis B, TWINRIX™ ADULT
- Medical subject headings
- Hepatitis B, Hepatitis A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWINRIX™ ADULTBiological
2 doses IM injection in primary study
Engerix TMBiological
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
| Study group | Role | What they receive |
|---|---|---|
| Twinrix Group | Experimental | Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076) Receives: Biological: TWINRIX™ ADULT |
| Engerix-B Additional Dose (Adult) | Experimental | Subjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose). Receives: Biological: Engerix TM |
| Engerix-B Additional Dose (Pediatric) | Experimental | Subjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose). Receives: Biological: Engerix TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Measured: Years 6, 7, 8, 9, and 10.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Measured: At Year 6, 7, 8, 9 and 10
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Measured: Before and 1 month after the additional dose administration
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
Immune response was defined as:
- anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points
- at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
Measured: One month after the additional dose administration
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: At Year 6, 7, 8, 9 and 10
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Measured: During the 4-day follow-up period after additional dose
Number of Subjects Reporting Unsolicited Adverse Events
Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 30-day follow-up period after additional dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the 30-day follow-up period after additional dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study start16 Feb 2004
- Primary completion15 Apr 2009
- Study completion15 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 178 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
- NCT00289744
- Sponsor's protocol ID
- 100561 (Y6)
- Other IDs
- 100562 (Year 7), 100563 (Year 8), 100564 (Year 9), 100565 (Year 10)
- Status last verified
- Jul 2018
- First submitted
- 9 Feb 2006
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-up Study to Evaluate the Immune Persistence of GSK Biologicals' Combined Hepatitis A / Hepatitis B Vaccine in Healthy Children
- ClinicalTrials.gov ID
- NCT00289744
- Acronym / sponsor ID
- 100561 (Y6)
- Conditions
- Hepatitis B, Hepatitis A
- Keywords
- Hepatitis A, Hepatitis B, TWINRIX™ ADULT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2004 (actual)
- Primary completion
- 15 Apr 2009 (actual)
- Study completion
- 15 Apr 2009 (actual)
- First posted
- 10 Feb 2006 (estimated)
- Results
- Posted 26 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.
This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.
If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Twinrix Group | Experimental | Biological: TWINRIX™ ADULTSubjects who received 2 doses (at Day 0 and Month 6) of Twinrix in the primary study (208127/076) |
| Engerix-B Additional Dose (Adult) | Experimental | Biological: Engerix TMSubjects aged 16 years and above who received an additional dose of EngerixTM-B (adult dose). |
| Engerix-B Additional Dose (Pediatric) | Experimental | Biological: Engerix TMSubjects under the age of 16 years who received an additional dose of EngerixTM-B (pediatric dose). |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
- Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TWINRIX™ ADULT2 doses IM injection in primary study | Biological | Twinrix Group |
| Engerix TMIf a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose. | Biological | Engerix-B Additional Dose (Adult), Engerix-B Additional Dose (Pediatric) |
Primary outcome
Anti-hepatitis A Virus (Anti-HAV) Antibody Concentration
Time frame: Years 6, 7, 8, 9, and 10.
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Time frame: At Year 6, 7, 8, 9 and 10
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration
Time frame: Before and 1 month after the additional dose administration
Number of Subjects With Immune Response to the Additional Dose of Engerix™-B
Time frame: One month after the additional dose administration
Immune response was defined as: * anti-hepatitis B surface antigen (anti-HBs) antibody concentration equal or above to 10 milli-international units per milliliter (mIU/mL) at 1 month post-challenge dose in subjects seronegative at the pre-challenge time-points * at least a 4-fold increase in anti-HBs antibody concentrations at 1 month post-challenge dose in subjects seropositive at the pre-challenge time-points.
Number of Subjects Reporting Serious Adverse Events (SAEs) Assessed by the Investigator as Causally Related to Primary Vaccination, Study Procedures or Lack of Vaccine Efficacy
Time frame: At Year 6, 7, 8, 9 and 10
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Solicited Local and General Symptoms
Time frame: During the 4-day follow-up period after additional dose
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: During the 30-day follow-up period after additional dose
Unsolicited adverse event (AE) covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the 30-day follow-up period after additional dose
Serious adverse events (SAEs) assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TWINRIX™ ADULT and Engerix TM in people with Hepatitis B and Hepatitis A, run by GlaxoSmithKline at 1 site in Belgium.
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 2 inclusion and 0 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 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 A Virus (Anti-HAV) Antibody Concentration (time frame: Years 6, 7, 8, 9, and 10.). The study lists 8 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 20 Aug 2018.