Last updated: 11/07/2018 01:35:39
Persistence of the immune response to hepatitis B in 7-9 years old children previously vaccinated with DTPa-HBV-IPV/Hib
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: Persistence of seroprotective antibody concentrations & immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
350
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Zinke M et al. (2009) Immune memory to hepatitis B virus in 4-9-year old children vaccinated in infancy with four doses of hexavalent DTPa-HBV-IPV/Hib vaccine. Hum Vaccin. 5(9): 592-598.
Zinke M et al. (2010) Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 6(2):189-193.
Medical condition
Hepatitis B
Product
SB217744
Collaborators
Not applicable
Study date(s)
July 2006 to December 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
7 - 9 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- A male or female aged 7 to 9 years at the time of study entry .
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Altenholz, Schleswig-Holstein, Germany, 24161
Status
Study Complete
Location
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
Status
Study Complete
Location
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24161
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Rudolstadt, Thueringen, Germany, 07407
Status
Study Complete
Location
GSK Investigational Site
Bad Sobernheim, Rheinland-Pfalz, Germany, 55566
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-14-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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