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

NCT01847430 | Completed Phase 4 Results

• 2 other identifiers: 1167222012-003950-10
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Hepatitis B

Keywords

Healthy; Hepatitis B; Adolescents; Engerix™-B Kinder

Outcome Measures

Primary Outcomes (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).

  One month after the challenge dose (Month 1)

Secondary Outcomes (7)

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

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

• Antibody Titers Against Hepatitis B Virus

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

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

  Prior to vaccination with the challenge dose

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

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

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

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

Study Arms (1)

HBV Group

EXPERIMENTAL

Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Biological: Engerix™-B Kinder

Interventions

Engerix™-B Kinder BIOLOGICAL

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

HBV Group

Eligibility Criteria

• Age: 15 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (10)

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

GSK Investigational Site

Bindlach, Bavaria, 95463, Germany

Location

GSK Investigational Site

Kirchheim, Bavaria, 85551, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04178, Germany

Location

GSK Investigational Site

Flensburg, Schleswig-Holstein, 24937, Germany

Location

GSK Investigational Site

Berlin, 13055, Germany

Location

GSK Investigational Site

Neumünster, 24534, Germany

Location

Related Publications (1)

• 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.

  PMID: 27095043 DERIVED

Related Links

• IPD for this study will be made available via the Clinical Study Data Request site.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 6, 2013
• Study Start: July 19, 2013
• Primary Completion: February 21, 2014
• Study Completion: February 21, 2014
• Last Updated: August 20, 2018
• Results First Posted: March 2, 2016

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

DE (10)