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Hepatitis BPhase 4NCT01847430

Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder

A Phase 4 study testing Engerix™-B Kinder in people with Hepatitis B, run by GlaxoSmithKline at 10 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects. Read more about this study

Who is it for?
Ages 15 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Hepatitis B
What is being tested?
Engerix™-B Kinder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
303 participants
Where
10 sitesGermany
Study dates
19 Jul 2013to 21 Feb 2014
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 15 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subject's parent(s)/guardians who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • A male or female between, and including, 15 and 16 years of age at the time of the vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • 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.
  • Documented evidence of previous vaccination with three consecutive doses of Engerix™-B Kinder in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
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  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.

Who cannot join

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Previous hepatitis B vaccination since administration of the third dose of Engerix™-B Kinder.
  • History of hepatitis B disease.
  • Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before study vaccine dose, or planned administration during the study period.
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  • 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 vaccine/product.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Acute disease and/or fever at the time of enrollment.
  • Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccine dose or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Germany10 sites

  • GSK Investigational Site

    Berlin, 13055

  • GSK Investigational Site

    Bindlach, Bavaria, 95463

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24937

  • GSK Investigational Site

    Frankenthal, Rhineland-Palatinate, 67227

  • GSK Investigational Site

    Goch, North Rhine-Westphalia, 47574

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Kirchheim, Bavaria, 85551

  • GSK Investigational Site

    Leipzig, Saxony, 04178

  • GSK Investigational Site

    Neumünster, 24534

  • GSK Investigational Site

    Tuttlingen, Baden-Wurttemberg, 78532

Other trials in Germany

About this study

Official title: Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Challenge Dose of GSK Biologicals' Hepatitis B Virus Vaccine, Engerix™-B Kinder (SKF103860), in 15-16 Years Old Adolescents, Vaccinated in Infancy With Engerix™-B Kinder

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.

Read the detailed description

This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013.

The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay (ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen) antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA).

Additionally, the threshold level of prednisone was modified to reflect the dosage normally prescribed to adolescents.

Conditions
Hepatitis B
Being tested
Engerix™-B Kinder
Keywords
Healthy, Hepatitis B, Adolescents, Engerix™-B Kinder
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

    Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.

Study groups in NCT01847430
Study groupRoleWhat they receive
HBV GroupExperimentalSubjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Receives: Biological: Engerix™-B Kinder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the 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)

  1. Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above the Cut Off Value.

    The cut-off values defined were ≥ 6.2 mIU/mL, ≥ 10 mIU/mL and ≥ 100 mIU/mL.

    Measured: Before (Day 0) and one month after the challenge dose (Month 1)

  2. Antibody Titers Against Hepatitis B Virus

    Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% CIs.

    Measured: Before (Day 0) and one month (Month 1) after the challenge dose

  3. Number of Subjects With an Anamnestic Response to the Challenge Dose in Relation to Their Pre Vaccination Status.

    Anamnestic response to the challenge dose was defined as:

    At least (i.e. greater than or equal to ) 4-fold rise in post-vaccination anti-HBs antibody concentrations in subjects seropositive at the pre-vaccination time point Post-vaccination anti-HB antibody concentrations ≥10 mIU/mL in subjects seronegative at the pre-vaccination time point

    Measured: Prior to vaccination with the challenge dose

  4. Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.

    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. >50 mm.

    Measured: During the 4-day (Days 0-3) follow-up period after the challenge dose

  5. Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.

    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C

    Measured: During the 4-day (Days 0-3) follow-up period after the challenge dose

  6. Number of Subjects Reporting 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

    Measured: During the 31-day (Days 0-30) follow-up period after the challenge dose

  7. Number of Subjects Reporting Any Serious Adverse Events (SAEs).

    Serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination.

    Measured: During the entire study period (Day 0 to Month 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2013 (estimated)
  2. Study start19 Jul 2013
  3. Primary completion21 Feb 2014
  4. Study completion21 Feb 2014

Resources

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
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01847430
Sponsor's protocol ID
116722
Other IDs
2012-003950-10
Status last verified
Jun 2018
First submitted
2 May 2013
Last updated
20 Aug 2018
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • Van Der Meeren O, Behre U, Crasta P. Immunity to hepatitis B persists in adolescents 15-16 years of age vaccinated in infancy with three doses of hepatitis B vaccine. Vaccine. 2016 May 23;34(24):2745-9. doi: 10.1016/j.vaccine.2016.04.013. Epub 2016 Apr 16.

    PubMed 27095043

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 10 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 12 inclusion and 15 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 10 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 2 Mar 2016). 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 Equal to or Above the Cut Off Value. (time frame: One month after the challenge dose (Month 1)). 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 NCT01847430, 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.

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