AzTrials
AzTrials

Hepatitis BPhase 4NCT02798952

A Study to Evaluate Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of Engerix™-B Kinder Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa During Infancy

A Phase 4 study testing Engerix-B Kinder in people with Hepatitis B, run by GlaxoSmithKline at 14 sites in Germany.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of… Read more about this study

Who is it for?
Ages 14 to 15 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
302 participants
Where
14 sitesGermany
Study dates
23 Aug 2016to 5 Jul 2017
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 14 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
  • In addition to the informed consent that will be signed by the parents/LAR(s), written informed assent of the subject will be sought.
  • A male or female between the ages of 14 to 15 at the time of vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age.
Show all 12Show fewer
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
  • 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 series.

Who cannot join

  • Child in care.
  • Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the dose of study vaccine, or planned use during the study period.
  • Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs at any time during the study period.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 30 days after the dose of HBV vaccine administration with the exception of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, which can be given as part of routine vaccination practice. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
Show all 22Show fewer
  • 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 (pharmaceutical product or device).
  • Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa booster in the second year of life.
  • History of or intercurrent hepatitis B disease.
  • Hepatitis B vaccination at birth.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • Major congenital defects or serious chronic illness including thrombocytopenia and bleeding disorders.
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrolment.
  • Fever is defined as temperature ≥37.5°C for oral, axillary or tympanic route, or ≥38.0°C for rectal route.
  • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the dose of study vaccine 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

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • GSK Investigational Site

    Berlin, 13055

  • GSK Investigational Site

    Bindlach, Bavaria, 95463

  • GSK Investigational Site

    Bramsche, 49565

  • GSK Investigational Site

    Cham, Bavaria, 93413

  • 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

    Mannheim, Baden-Wurttemberg, 68161

  • GSK Investigational Site

    Mönchengladbach, 41236

  • GSK Investigational Site

    Neumünster, 24534

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70499

  • GSK Investigational Site

    Tuttlingen, Baden-Wurttemberg, 78532

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

  • GSK Investigational Site

    Wurzen, Saxony, 04808

Other trials in Germany

About this study

Official title: Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Hepatitis B Vaccine, Engerix™-B Kinder (SKF103860) Challenge Dose, in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa (SB217744) During Infancy

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 14-15 years who were vaccinated with four doses of Infanrix™-Hexa in the first two years of life and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.

Conditions
Hepatitis B
Being tested
Engerix-B Kinder
Keywords
Hepatitis B antibodies, Safety, Challenge dose, Persistence, Engerix B Kinder, Infanrix hexa, Immunogenicity, Adolescents
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

    Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.

Study groups in NCT02798952
Study groupRoleWhat they receive
HBV GroupExperimentalSubjects received a single challenge dose of Engerix-B Kinder.
Receives: Biological: Engerix-B Kinder

What is being measured

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

  1. Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations

    Concentrations were expressed in geometric mean concentrations (GMCs).

    Measured: At Day 30.

Secondary outcomes (8)

  1. Anti-HBs Antibody Concentrations

    Concentrations were expressed in geometric mean concentrations (GMCs).

    Measured: At Day 0

  2. Number of Seropositive Subjects for Anti-HBs.

    A seropositve subject was defined as a subject with anti-HBs antibody concentrations above the assay cut-off (≥ 6.2 mIU/ml).

    Measured: At Day 0 and Day 30

  3. Number of Seroprotected Subjects for Anti-HBs.

    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations equal to or above 10 milli-International units per milliliter (mIU/ml).

    Measured: At Day 0 and day 30

  4. Number of Subjects With Anti-HBs Concentrations Above the Cut-off.

    The cut-off of the assay was ≥ 100 mIU/mL.

    Measured: At Day 0 and Day 30

  5. Number of Subjects With an Anamnestic Response to the Hepatitis B Challenge Dose.

    Anamnestic response was defined as:

    For initially seronegative subjects: antibody concentration ≥10mIU/mL. For initially seropositive subjects: antibody concentration at least four times the pre-challenge antibody concentration.

    Measured: At Day 30

  6. Number of Subjects With Any Solicited Local and General Symptoms.

    Solicited local symptoms assessed were pain, redness and swelling at injection site. Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (defined as axillary temperature ≥ 37.5°C).

    Measured: Within 4 days (Day 0 - Day 3) after the vaccination

  7. Number of Subjects With Unsolicited Adverse Events (AEs)

    An unsolicited AE was defined as any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: Within 31 days (Day 0 - Day 30) after the vaccination.

  8. Number of Subjects With Serious Adverse Events (SAEs)

    An SAE was defined as 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.

    Measured: From Day 0 to Day 30

Timeline

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

  1. First posted14 Jun 2016 (estimated)
  2. Study start23 Aug 2016
  3. Primary completion5 Jul 2017
  4. Study completion5 Jul 2017

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
302 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02798952
Sponsor's protocol ID
106794
Other IDs
2015-003391-74, 2015
Status last verified
Jan 2020
First submitted
9 Jun 2016
Last updated
18 Jan 2020
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

  • Schwarz TF, Behre U, Adelt T, Donner M, Suryakiran PV, Janssens W, Mesaros N, Panzer F. Long-term antibody persistence against hepatitis B in adolescents 14-15-years of age vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy. Hum Vaccin Immunother. 2019;15(1):235-241. doi: 10.1080/21645515.2018.1509658. Epub 2018 Sep 11.

    PubMed 30118633

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 14 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 22 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 Feb 2019). 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 B Surface (Anti-HBs) Antibody Concentrations (time frame: At Day 30.). 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 NCT02798952, 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 18 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in