Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B and Immune Response to a Hepatitis B Challenge Dose in Healthy Children 7 to 9 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine
1 other identifier
interventional
350
1 country
42
Brief Summary
Persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Shorter than P25 for phase_4
42 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
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 25, 2006
CompletedFirst Posted
Study publicly available on registry
July 26, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 12, 2016
October 1, 2016
July 25, 2006
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anti-HBs antibody concentration
Secondary Outcomes (2)
Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
Sol & unsol symptoms after HBV vaccination, SAEs
Interventions
Eligibility Criteria
You may qualify if:
- A male or female aged 7 to 9 years at the time of study entry .
- Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine or a total of 4 doses of HBV vaccine in previous vaccination studies.
- Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib or HBV vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Ettenheim, Baden-Wurttemberg, 77955, Germany
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694, Germany
GSK Investigational Site
Oberkirch, Baden-Wurttemberg, 77704, Germany
GSK Investigational Site
Offenburg, Baden-Wurttemberg, 77654, Germany
GSK Investigational Site
Aichach, Bavaria, 86551, Germany
GSK Investigational Site
Bobingen, Bavaria, 86399, Germany
GSK Investigational Site
Erding, Bavaria, 85435, Germany
GSK Investigational Site
Kaufering, Bavaria, 86916, Germany
GSK Investigational Site
Kempten (Allgäu), Bavaria, 87435, Germany
GSK Investigational Site
Landsberg am Lech, Bavaria, 86899, Germany
GSK Investigational Site
Lohr, Bavaria, 97816, Germany
GSK Investigational Site
Munich, Bavaria, 81241, Germany
GSK Investigational Site
Munich, Bavaria, 81243, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Pegnitz, Bavaria, 91257, Germany
GSK Investigational Site
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Weilheim, Bavaria, 82362, Germany
GSK Investigational Site
Hamburg, Hamburg, 22415, Germany
GSK Investigational Site
Marburg/Lahn, Hesse, 35039, Germany
GSK Investigational Site
Salzgitter, Lower Saxony, 38226, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Bad Sobernheim, Rhineland-Palatinate, 55566, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Schoeneberg - Kuebelberg, Rhineland-Palatinate, 66901, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290, Germany
GSK Investigational Site
Bischofswerda, Saxony, 01877, Germany
GSK Investigational Site
Dresden, Saxony, 01307, Germany
GSK Investigational Site
Altenholz, Schleswig-Holstein, 24161, Germany
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, 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
Niebüll, Schleswig-Holstein, 25899, Germany
GSK Investigational Site
Berlin, State of Berlin, 10249, Germany
GSK Investigational Site
Berlin, State of Berlin, 10999, Germany
GSK Investigational Site
Berlin, State of Berlin, 13355, Germany
GSK Investigational Site
Berlin, State of Berlin, 13507, Germany
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356, Germany
GSK Investigational Site
Rudolstadt, Thuringia, 07407, Germany
Related Publications (1)
Zinke M, Disselhoff J; DTP a-HBV-IPV-110 and -111 study groups; Gartner B, Jacquet JM. Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 2010 Feb;6(2):189-93. doi: 10.4161/hv.6.2.10117.
PMID: 20009522DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2006
First Posted
July 26, 2006
Study Start
July 1, 2006
Study Completion
December 1, 2006
Last Updated
October 12, 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.