Hepatitis BPhase 4NCT00984139
Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination
A Phase 4 study testing Engerix™-B Kinder in people with Hepatitis B, run by GlaxoSmithKline at 24 sites in Germany.
Trial summary
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy. Read more about this study
- Who is it for?
- Ages 12 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix™-B Kinder
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 24 sitesGermany
- Study dates
- 12 Oct 2009to 7 Apr 2010
- Phase
- Phase 4
- 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 12 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female of 12 to 13 years of age at the time of enrolment.
- With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
- Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
- Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
Who cannot join
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix-B vaccine.
- History of hepatitis B disease.
- Hepatitis B vaccination at birth.
- Adolescents living in institutional care.
- Planned administration /administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after.
Show all 14Show fewer
- Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge..
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
- Acute disease and/or fever at the time of enrolment.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
Germany24 sites
GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 10967
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Braunatal, Hesse, 34225
GSK Investigational Site
Cham, Bavaria, 93413
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47137
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Gilching, Bavaria, 82205
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435
GSK Investigational Site
Kirchheim, Bavaria, 85551
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68163
GSK Investigational Site
Munich, Bavaria, 81375
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163
GSK Investigational Site
Nördlingen, Bavaria, 86720
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, 75172
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532
GSK Investigational Site
Weimar, Thuringia, 99425
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
About this study
Official title: Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine (Engerix™-B)
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.
- Conditions
- Hepatitis B
- Being tested
- Engerix™-B Kinder
- Keywords
- persistence, HBV, Long-term, Engerix™-B Kinder, Hepatitis B, adolescent
- 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™-B KinderBiological
Also called HBV vaccine, Engerix™-B
Intramuscular, one dose.
| Study group | Role | What they receive |
|---|---|---|
| Engerix-B Group | Experimental | Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0). Receives: Biological: Engerix™-B Kinder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Measured: One month after the challenge dose (Month 1)
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Measured: One month after the challenge dose (Month 1)
Secondary outcomes (7)
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
The cut-off values were defined as 3.3 mIU/mL, 10 mIU/mL and 100 mIU/mL.
Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.
Measured: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values
The cut-off values were defined as 6.2 mIU/mL, 10 mIU/mL and 100 mIU/mL. Note: the number of subjects with anti-HBs antibody concentrations equal to or above 100 mIU/mL on month post-challenge dose data are presented as a primary outcome measure.
Measured: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Solicited Local and General Symptoms
Solicited local symptoms were pain, redness and swelling. Solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever.
Fever was defined as axillary temperature greater than or equal to 37.5 degrees Celsius.
Measured: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Unsolicited 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 31-day (Day 0-30) follow-up period following the challenge dose vaccination
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are 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: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.
Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration equal to or greater than 3.3 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations less than 3.3 mIU/mL) at the pre-challenge dose time point.
Measured: One month after the challenge dose (Month 1)
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.
Anamnestic response was defined as: - At least (i.e. greater than or equal to) a 4-fold rise in post-challenge vaccine dose anti-HBs antibody concentrations in subjects seropositive (i.e. with anti-HBs antibody concentration ≥ 6.2 mIU/mL) at the pre-challenge dose time point. - Post-challenge dose anti-HBs antibody concentrations equal to or greater than 10 mIU/mL in subjects seronegative (i.e. with anti-HBs antibody concentrations < 6.2 mIU/mL) at the pre-challenge dose time point.
Measured: One month after the challenge dose (Month 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study start12 Oct 2009
- Primary completion7 Apr 2010
- Study completion7 Apr 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 306 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
- NCT00984139
- Sponsor's protocol ID
- 112682
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2009
- Last updated
- 20 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Publications
Behre U, Bleckmann G, Crasta PD, Leyssen M, Messier M, Jacquet JM, Hardt K. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 2012 Jun;8(6):813-8. doi: 10.4161/hv.19898. Epub 2012 Apr 17.
PubMed 22508412
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 Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine (Engerix™-B)
- ClinicalTrials.gov ID
- NCT00984139
- Acronym / sponsor ID
- 112682
- Conditions
- Hepatitis B
- Keywords
- persistence, HBV, Long-term, Engerix™-B Kinder, Hepatitis B, adolescent
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2009
- Primary completion
- 7 Apr 2010 (actual)
- Study completion
- 7 Apr 2010 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Posted 1 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Engerix-B Group | Experimental | Biological: Engerix™-B KinderSubjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0). |
Who may qualify
- Ages
- 12 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
- A male or female of 12 to 13 years of age at the time of enrolment.
- With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
- Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s).
Key exclusion criteria (14 listed)
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix-B vaccine.
- History of hepatitis B disease.
- Hepatitis B vaccination at birth.
- Adolescents living in institutional care.
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™-B KinderAlso: HBV vaccine, Engerix™-BIntramuscular, one dose. | Biological | Engerix-B Group |
Primary outcome
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value
Time frame: One month after the challenge dose (Month 1)
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ChemiLuminescence ImmunoAssay (CLIA) Equal to or Above Cut-off Value.
Time frame: One month after the challenge dose (Month 1)
The cut-off value was defined as 100 milli-international units per milliliter (mIU/mL).
7 secondary outcomes
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Values
Time frame: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Anti-HBs Antibody Concentrations as Measured by CLIA Equal to or Above Cut-off Values
Time frame: Before (Day 0) and one month (Month 1) after the challenge dose
Number of Subjects With Solicited Local and General Symptoms
Time frame: During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: After the challenge dose of the vaccine (Day 0) up to the study end (Month 1)
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by ELISA.
Time frame: One month after the challenge dose (Month 1)
Number of Subjects With Anamnestic Response to the Challenge Dose as Measured by CLIA.
Time frame: One month after the challenge dose (Month 1)
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.
- Derived from this study: PubMed 22508412Behre U, Bleckmann G, Crasta PD, Leyssen M, Messier M, Jacquet JM, Hardt K. Long-term anti-HBs antibody persistence and immune memory in children and adolescents who received routine childhood hepatitis B vaccination. Hum Vaccin Immunother. 2012 Jun;8(6):813-8. doi: 10.4161/hv.19898. Epub 2012 Apr 17.
- 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
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engerix™-B Kinder in people with Hepatitis B, run by GlaxoSmithKline at 24 sites in Germany.
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 8 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 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 24 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 1 Mar 2011). 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?
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations as Measured by ELISA Equal to or Above Cut-off Value (time frame: One month after the challenge dose (Month 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984139, which also lists 1 linked publication.
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.