Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).
1 other identifier
interventional
301
1 country
35
Brief Summary
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2007
Shorter than P25 for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedStudy Start
First participant enrolled
August 31, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2007
CompletedResults Posted
Study results publicly available
May 27, 2009
CompletedAugust 17, 2018
November 1, 2016
4 months
August 21, 2007
December 17, 2008
July 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations Above the Cut-off Value
Anti-HBs antibody cut-off value assessed was 100 milli-international unit per milliliter (mIU/mL)
One month after the challenge dose of HBV vaccine
Secondary Outcomes (5)
Number of Participants With Anti-HBs Antibody Concentrations Above the Cut-off Value
Before challenge dose of HBV vaccine
Number of Participants Reporting Solicited Local Symptoms
During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Solicited General Symptoms
During the 4-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Unsolicited Adverse Events
During the 31-day follow-up period after the challenge dose of HBV vaccine.
Number of Participants Reporting Serious Adverse Events (SAE)
After the challenge dose of HBV vaccine.
Study Arms (1)
Group Engerix
EXPERIMENTALSubjects received a single challenge dose of Engerix™ (hepatitis-B \[HBV\] vaccine)
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) at the time of enrolment.
- With documented evidence of previous vaccination with three consecutive doses of Engerix™-B in Germany
- Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
You may not qualify if:
- 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 or intercurrent hepatitis B disease.
- Hepatitis B vaccination at birth.
- 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 (defined as more than 14 days) 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (35)
GSK Investigational Site
Birkenfeld, Baden-Wurttemberg, 75217, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Heidelberg, Baden-Wurttemberg, 69120, Germany
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, 76189, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704, Germany
GSK Investigational Site
Oberstenfeld, Baden-Wurttemberg, 71720, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654, Germany
GSK Investigational Site
Pforzheim, Baden-Wurttemberg, 75172, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Bindlach, Bavaria, 95463, Germany
GSK Investigational Site
Kaufering, Bavaria, 86916, Germany
GSK Investigational Site
Lohr, Bavaria, 97816, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Tegernsee, Bavaria, 83684, Germany
GSK Investigational Site
Löhne, North Rhine-Westphalia, 32584, Germany
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48163, Germany
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24943, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Kiel, Schleswig-Holstein, 24161, Germany
GSK Investigational Site
Berlin, 10967, Germany
GSK Investigational Site
Berlin, 12679, Germany
GSK Investigational Site
Berlin, 13055, Germany
GSK Investigational Site
Berlin, 13507, Germany
Related Publications (1)
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.
PMID: 22508412DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 22, 2007
Study Start
August 31, 2007
Primary Completion
December 31, 2007
Study Completion
December 31, 2007
Last Updated
August 17, 2018
Results First Posted
May 27, 2009
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.