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Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Primary Purpose

Hepatitis B

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
hepatitis B vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis B focused on measuring Prophylaxis for hepatitis B disease

Eligibility Criteria

7 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Anti-HBs antibody concentration

Secondary Outcome Measures

Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
Sol & unsol symptoms after HBV vaccination, SAEs

Full Information

First Posted
July 25, 2006
Last Updated
October 11, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00356564
Brief Title
Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B
Keywords
Prophylaxis for hepatitis B disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
hepatitis B vaccine
Primary Outcome Measure Information:
Title
Anti-HBs antibody concentration
Secondary Outcome Measure Information:
Title
Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
Title
Sol & unsol symptoms after HBV vaccination, SAEs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ettenheim
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77955
Country
Germany
Facility Name
GSK Investigational Site
City
Kehl
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77694
Country
Germany
Facility Name
GSK Investigational Site
City
Oberkirch
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77704
Country
Germany
Facility Name
GSK Investigational Site
City
Offenburg
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
77654
Country
Germany
Facility Name
GSK Investigational Site
City
Aichach
State/Province
Bayern
ZIP/Postal Code
86551
Country
Germany
Facility Name
GSK Investigational Site
City
Bobingen
State/Province
Bayern
ZIP/Postal Code
86399
Country
Germany
Facility Name
GSK Investigational Site
City
Erding
State/Province
Bayern
ZIP/Postal Code
85435
Country
Germany
Facility Name
GSK Investigational Site
City
Kaufering
State/Province
Bayern
ZIP/Postal Code
86916
Country
Germany
Facility Name
GSK Investigational Site
City
Kempten
State/Province
Bayern
ZIP/Postal Code
87435
Country
Germany
Facility Name
GSK Investigational Site
City
Landsberg
State/Province
Bayern
ZIP/Postal Code
86899
Country
Germany
Facility Name
GSK Investigational Site
City
Lohr
State/Province
Bayern
ZIP/Postal Code
97816
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Facility Name
GSK Investigational Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81243
Country
Germany
Facility Name
GSK Investigational Site
City
Noerdlingen
State/Province
Bayern
ZIP/Postal Code
86720
Country
Germany
Facility Name
GSK Investigational Site
City
Pegnitz
State/Province
Bayern
ZIP/Postal Code
91257
Country
Germany
Facility Name
GSK Investigational Site
City
Tutzing
State/Province
Bayern
ZIP/Postal Code
82327
Country
Germany
Facility Name
GSK Investigational Site
City
Weilheim
State/Province
Bayern
ZIP/Postal Code
82362
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg/Lahn
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
Facility Name
GSK Investigational Site
City
Salzgitter
State/Province
Niedersachsen
ZIP/Postal Code
38226
Country
Germany
Facility Name
GSK Investigational Site
City
Erkrath
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40699
Country
Germany
Facility Name
GSK Investigational Site
City
Krefeld
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47798
Country
Germany
Facility Name
GSK Investigational Site
City
Willich
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
47877
Country
Germany
Facility Name
GSK Investigational Site
City
Bad Sobernheim
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55566
Country
Germany
Facility Name
GSK Investigational Site
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
GSK Investigational Site
City
Schoeneberg - Kuebelberg
State/Province
Rheinland-Pfalz
ZIP/Postal Code
66901
Country
Germany
Facility Name
GSK Investigational Site
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54290
Country
Germany
Facility Name
GSK Investigational Site
City
Bischofswerda
State/Province
Sachsen
ZIP/Postal Code
01877
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Altenholz
State/Province
Schleswig-Holstein
ZIP/Postal Code
24161
Country
Germany
Facility Name
GSK Investigational Site
City
Bredstedt
State/Province
Schleswig-Holstein
ZIP/Postal Code
25821
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24937
Country
Germany
Facility Name
GSK Investigational Site
City
Flensburg
State/Province
Schleswig-Holstein
ZIP/Postal Code
24944
Country
Germany
Facility Name
GSK Investigational Site
City
Husum
State/Province
Schleswig-Holstein
ZIP/Postal Code
25813
Country
Germany
Facility Name
GSK Investigational Site
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24161
Country
Germany
Facility Name
GSK Investigational Site
City
Niebuell
State/Province
Schleswig-Holstein
ZIP/Postal Code
25899
Country
Germany
Facility Name
GSK Investigational Site
City
Lobenstein
State/Province
Thueringen
ZIP/Postal Code
07356
Country
Germany
Facility Name
GSK Investigational Site
City
Rudolstadt
State/Province
Thueringen
ZIP/Postal Code
07407
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10999
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13355
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13507
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22415
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
20009522
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106744
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106744
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106744
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106744
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106744
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106744
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Persistence of the Immune Response to Hepatitis B in 7-9 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

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