Persistence of Immunity Against Hepatitis B in 12-13 Year Old Adolescents After Infant Hepatitis B Vaccination

NCT ID: NCT00984139

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-12
• Study Completion Date: 2010-04-07

Brief Summary

This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.

Conditions

Hepatitis B

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Engerix-B Group

Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).

Group Type: EXPERIMENTAL

Engerix™-B Kinder

Intervention Type: BIOLOGICAL

Intramuscular, one dose.

Interventions

Engerix™-B Kinder

Intramuscular, one dose.

Intervention Type: BIOLOGICAL

Other Intervention Names

HBV vaccine; Engerix™-B

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol.
• A male or female of 12 to 13 years of age at the time of enrolment.
• With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age.
• Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment.
• 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.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.

Exclusion Criteria

• 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 hepatitis B disease.
• Hepatitis B vaccination at birth.
• Adolescents living in institutional care.
• 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 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 (no laboratory testing required).
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
• Acute disease and/or fever at the time of enrolment.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Pforzheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Bindlach, Bavaria, Germany

GSK Investigational Site

Cham, Bavaria, Germany

GSK Investigational Site

Gilching, Bavaria, Germany

GSK Investigational Site

Kempten (Allgäu), Bavaria, Germany

GSK Investigational Site

Kirchheim, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Munich, Bavaria, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Braunatal, Hesse, Germany

GSK Investigational Site

Duisburg, North Rhine-Westphalia, Germany

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

GSK Investigational Site

Weimar, Thuringia, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 22508412 (View on PubMed)

Study Documents

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

112682

Identifier Type: -

Identifier Source: org_study_id