Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
Assess Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Years (Previously Primed & Boosted in the 1st 2 Years of Life With DTPa-HBV-IPV/Hib Vaccine)
1 other identifier
interventional
301
1 country
36
Brief Summary
The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™. 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 Dec 2006
Shorter than P25 for phase_4
36 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
Study Start
First participant enrolled
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedOctober 28, 2016
October 1, 2016
5 months
December 13, 2006
October 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Anti-hepatitis B surface antigen (HBs) antibody concentrations
One month after the challenge dose of HBV vaccine
Secondary Outcomes (2)
Anti-HBs antibody concentrations
Before and after challenge dose of HBV vaccine
Occurrence of serious adverse events
During the entire study period.
Study Arms (1)
Group A
EXPERIMENTALInterventions
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 4 to 5 years of age at the time of enrolment.
- With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ 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 fourth dose of Infanrix hexa™ booster in the second year of life.
- 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 booster vaccination and ending 30 days after.
- Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (36)
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Bietigheim-Bissingen, Baden-Wurttemberg, 74321, Germany
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357, Germany
GSK Investigational Site
Ehingen, Baden-Wurttemberg, 89584, Germany
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Herbolzheim, Baden-Wurttemberg, 79336, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Kirchzarten, Baden-Wurttemberg, 79199, 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
Tettnang, Baden-Wurttemberg, 88069, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Munich, Bavaria, 81735, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Olching, Bavaria, 82140, Germany
GSK Investigational Site
Tegernsee, Bavaria, 83684, Germany
GSK Investigational Site
Dudenhofen, Rhineland-Palatinate, 67373, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Gau-Odernheim, Rhineland-Palatinate, 55239, Germany
GSK Investigational Site
Gerolstein, Rhineland-Palatinate, 54568, Germany
GSK Investigational Site
Schoeneberg - Kuebelberg, Rhineland-Palatinate, 66901, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Leipzig, Saxony, 04317, Germany
GSK Investigational Site
Berlin, State of Berlin, 10315, Germany
GSK Investigational Site
Berlin, State of Berlin, 10967, Germany
GSK Investigational Site
Berlin, State of Berlin, 12679, Germany
GSK Investigational Site
Berlin, State of Berlin, 13055, Germany
GSK Investigational Site
Berlin, State of Berlin, 13355, Germany
GSK Investigational Site
Berlin, State of Berlin, 13507, Germany
GSK Investigational Site
Berlin, State of Berlin, 14197, Germany
Related Publications (1)
Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, Jacquet JM, Schuster V. Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis. 2010 Jan 15;10:9. doi: 10.1186/1471-2334-10-9.
PMID: 20078876BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
December 13, 2006
First Posted
December 14, 2006
Study Start
December 1, 2006
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
October 28, 2016
Record last verified: 2016-10
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.