Hepatitis B VaccinePhase 4NCT00519649
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
A Phase 4 study testing Engerix™-B Kinder in people with Hepatitis B Vaccine, run by GlaxoSmithKline at 35 sites in Germany.
Trial summary
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B Vaccine
- 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
- 301 participants
- Where
- 35 sitesGermany
- Study dates
- 31 Aug 2007to 31 Dec 2007
- 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 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
- With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany
- Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
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 or intercurrent hepatitis B disease.
- Hepatitis B vaccination at birth.
- 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.
- 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 (defined as more than 14 days) 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Germany35 sites
GSK Investigational Site
Berlin, 10967
GSK Investigational Site
Berlin, 12679
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 13507
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Birkenfeld, Baden-Wurttemberg, 75217
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76189
GSK Investigational Site
Kaufering, Bavaria, 86916
GSK Investigational Site
Kiel, Schleswig-Holstein, 24161
GSK Investigational Site
Leipzig, Saxony, 04103
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Lohr, Bavaria, 97816
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Munich, Bavaria, 81735
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, 75172
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Tegernsee, Bavaria, 83684
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
About this study
Official title: An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Conditions
- Hepatitis B Vaccine
- Being tested
- Engerix™-B Kinder
- Keywords
- Hepatitis B vaccine, Challenge dose
- 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
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Group Engerix | Experimental | Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) Receives: Biological: Engerix™-B Kinder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
Measured: One month after the challenge dose of HBV vaccine
Secondary outcomes (5)
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off values assessed include 3.3, 10 and 100 mIU/mL
Measured: Before challenge dose of HBV vaccine
Number of Participants Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling
Measured: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Solicited General Symptoms
Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms, and headache
Measured: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Unsolicited Adverse Events
An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: During the 31-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that:
results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: After the challenge dose of HBV vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study start31 Aug 2007
- Primary completion31 Dec 2007
- Study completion31 Dec 2007
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 B VaccineStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 301 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
- NCT00519649
- Sponsor's protocol ID
- 110474
- Status last verified
- Nov 2016
- First submitted
- 21 Aug 2007
- Last updated
- 17 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 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).
- ClinicalTrials.gov ID
- NCT00519649
- Acronym / sponsor ID
- 110474
- Conditions
- Hepatitis B Vaccine
- Keywords
- Hepatitis B vaccine, Challenge dose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2007
- Primary completion
- 31 Dec 2007 (actual)
- Study completion
- 31 Dec 2007 (actual)
- First posted
- 22 Aug 2007 (estimated)
- Results
- Posted 27 May 2009
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 this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Engerix | Experimental | Biological: Engerix™-B KinderSubjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine) |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
- With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany
- Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (8 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 or intercurrent hepatitis B disease.
- Hepatitis B vaccination at birth.
- 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.
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 KinderIntramuscular injection, 1 dose | Biological | Group Engerix |
Primary outcome
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
Time frame: One month after the challenge dose of HBV vaccine
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
5 secondary outcomes
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
Time frame: Before challenge dose of HBV vaccine
Number of Participants Reporting Solicited Local Symptoms
Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Solicited General Symptoms
Time frame: During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Unsolicited Adverse Events
Time frame: During the 31-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Serious Adverse Events (SAE)
Time frame: After the challenge dose of HBV vaccine.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 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
35 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 Vaccine, run by GlaxoSmithKline at 35 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 5 inclusion and 8 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 17 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 35 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 27 May 2009). 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 Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value (time frame: One month after the challenge dose of HBV vaccine). 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 NCT00519649, 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 17 Aug 2018.