Hepatitis BPhase 4NCT02052661

This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa

A Phase 4 study testing Engerix™-B Kinder in people with Hepatitis B, run by GlaxoSmithKline at 11 sites in Germany.

Completed

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

Trial summary

The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B… 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: 301 participants
Where: 11 sitesGermany
Study dates: 18 Feb 2014to 23 Sep 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 12 to 13 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
A male or female between the ages of 12 to 13 (from and including the 12th birthday, up to but excluding the 14th birthday) at the time of enrolment.
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.
Written informed consent obtained from the parents/LAR(s) of the subject.
In addition to the informed consent that will be signed by the parents/LAR(s), written informed assent of the subject will be sought.
Healthy subjects as established by medical history and clinical examination before entering into the study.

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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 series.

Who cannot join

Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
Administration of any chronic drug therapy to be continued during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV challenge dose, with the exception of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (dTpa) vaccine, which can be given as part of routine vaccination practice.

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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 (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 (no laboratory testing required).
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 on rectal route. The preferred route for recording temperature in this study will be axillary.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) 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 within the 3 months preceding 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

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Germany11 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
Leipzig, Saxony, 04178
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584
GSK Investigational Site
Neumünster, 24534
GSK Investigational Site
Radebeul, Saxony, 01445
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532

Other trials in Germany

About this study

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

Conditions: Hepatitis B
Being tested: Engerix™-B Kinder
Keywords: Infanrix™ hexa, Hepatitis B antibodies, Immunogenicity, Hepatitis B, Adolescents, Infancy, Engerix™-B Kinder, Safety
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 deltoid region of non-dominant arm.

Study groups in NCT02052661
Study group	Role	What they receive
Engerix-B Kinder Group	Experimental	Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid 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.

Anti-HBs Immune Response
Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.
Measured: One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)

Secondary outcomes (8)

Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 6.2 mIU/ml.
Measured: Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.
A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 milli-international units per milliliter (mIU/ml). A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.
Measured: Before the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.
A seropositive subject was defined as a subject with anti-HBs antibody concentrations ≥ 6.2 mIU/ml. A seroprotected subjects was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/ml.
Measured: 1 month after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.
The amnestic response to the challenge dose 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: One month after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to oe above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
An unsolicited AE covers 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 and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (Day 0-30) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Serious Adverse Events (SAEs).
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 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.

18 Feb 201423 Sep 2014

First posted3 Feb 2014 (estimated)
Study start18 Feb 2014
Primary completion23 Sep 2014
Study completion23 Sep 2014

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 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02052661
Sponsor's protocol ID: 106793
Other IDs: 2013-002821-41
Status last verified: Apr 2017
First submitted: 30 Jan 2014
Last updated: 6 Jun 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
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Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
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Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
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All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine Engerix™-B Kinder (SKF103860) Challenge Dose in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa (SB217744) During Infancy
ClinicalTrials.gov ID: NCT02052661
Acronym / sponsor ID: 106793
Conditions: Hepatitis B
Keywords: Infanrix™ hexa, Hepatitis B antibodies, Immunogenicity, Hepatitis B, Adolescents, Infancy, Engerix™-B Kinder, Safety
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 18 Feb 2014
Primary completion: 23 Sep 2014 (actual)
Study completion: 23 Sep 2014 (actual)
First posted: 3 Feb 2014 (estimated)
Results: Posted 27 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 Kinder Group	Experimental	Biological: Engerix™-B KinderSubjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.

Who may qualify

Ages: 12 to 13 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (12 listed)

Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
A male or female between the ages of 12 to 13 (from and including the 12th birthday, up to but excluding the 14th birthday) at the time of enrolment.
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.
Written informed consent obtained from the parents/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (22 listed)

Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
Administration of any chronic drug therapy to be continued during the study period.

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 KinderSingle dose administered intramuscularly in deltoid region of non-dominant arm.	Biological	Engerix-B Kinder Group

Primary outcome

Anti-HBs Immune Response
Time frame: One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1)
Anti-HBs immune response was defined as the number of subjects with Anti-HBs antibody concentrations ≥ 100 mIU/ml.

8 secondary outcomes

Anti-HBs Antibody Concentrations at 12-13 Years of Age, After Previous Vaccination With Infanrix Hexa.
Time frame: Before (PRE) and 1 month after (POST) the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml, ≥ 10 mIU/ml, 10 to < 100 mIU/ml and ≥ 100 mIU/ml.
Time frame: Before the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Anti-HBs Antibody Concentrations ≥ 6.2 mIU/ml and ≥ 10 mIU/ml.
Time frame: 1 month after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With an Anamnestic Response to the Single Challenge Dose of Engerix-B Kinder Vaccine.
Time frame: One month after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Solicited Local Symptoms.
Time frame: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Solicited General Symptoms.
Time frame: During the 4-day (Day 0-3) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During the 31-day (Day 0-30) follow-up period after the single challenge dose of Engerix-B Kinder vaccine.
Number of Subjects With Serious Adverse Events (SAEs).
Time frame: From Month 0 to Month 1

Results and safety

Results posted to the registry on 27 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Engerix-B Kinder Group	300	300

Primary outcome: Anti-HBs Immune Response

Time frame: One month after the single challenge dose of Engerix-B Kinder vaccine (Month 1). Number. Unit: Subject

Measure	Engerix-B Kinder Group n = 289
Value	272

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component at the post-vaccination time points.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: during the 4-day (Day 0-3) follow-up period after vaccination Unsolicited AEs: during the 31-day (Day 0-30) follow-up period after vaccination SAEs: During the entire study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Engerix-B Kinder Group	2 of 300 (0.7%)	200 of 300 (66.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Related trials for Hepatitis B

Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Active, not recruitingPhase 2
A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Hepatitis B
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
RecruitingObservational study
Evaluation of Patients With Liver Disease
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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

11 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 11 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 Aug 2015). 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-HBs Immune Response (time frame: One month after the single challenge dose of Engerix-B Kinder vaccine (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 NCT02052661.

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 6 Jun 2018.