Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 4 to 6 Years Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine
1 other identifier
interventional
300
1 country
38
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 Jun 2006
Shorter than P25 for phase_4
38 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
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 9, 2006
CompletedFirst Posted
Study publicly available on registry
June 12, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedOctober 7, 2016
October 1, 2016
June 9, 2006
October 6, 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 4 to 6 years at the time of study entry .
- Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib 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 vaccine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (38)
GSK Investigational Site
Bad Saulgau, Baden-Wurttemberg, 88348, Germany
GSK Investigational Site
Bönnigheim, Baden-Wurttemberg, 74357, Germany
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
Schwäbisch Hall, Baden-Wurttemberg, 74523, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469, Germany
GSK Investigational Site
Tuttlingen, Baden-Wurttemberg, 78532, Germany
GSK Investigational Site
Cham, Bavaria, 93413, Germany
GSK Investigational Site
Freising, Bavaria, 85354, Germany
GSK Investigational Site
Kaufering, Bavaria, 86916, Germany
GSK Investigational Site
Landsberg am Lech, Bavaria, 86899, Germany
GSK Investigational Site
Munich, Bavaria, 80939, 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
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Weilheim, Bavaria, 82362, Germany
GSK Investigational Site
Salzgitter, Lower Saxony, 38226, Germany
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699, Germany
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579, Germany
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Krefeld, North Rhine-Westphalia, 47798, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, 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
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, 24943, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24944, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Berlin, State of Berlin, 10315, Germany
GSK Investigational Site
Berlin, State of Berlin, 12627, Germany
GSK Investigational Site
Berlin, State of Berlin, 13355, 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
June 9, 2006
First Posted
June 12, 2006
Study Start
June 1, 2006
Study Completion
November 1, 2006
Last Updated
October 7, 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.