Clinical trial NCT00356564: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Prophylaxis for hepatitis B disease
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-07-26
Enrollment: 350
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Anti-HBs antibody concentration
Secondary outcomes:
measure: Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.
measure: Sol & unsol symptoms after HBV vaccination, SAEs
Other outcomes:
Locations:
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberkirch
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Offenburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aichach
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Bobingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Erding
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kaufering
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Kempten
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Landsberg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Lohr
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Muenchen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Noerdlingen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Pegnitz
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Tutzing
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Weilheim
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Marburg/Lahn
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Salzgitter
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
city: Erkrath
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Krefeld
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Willich
country: Germany
facility: GSK Investigational Site
state: Nordrhein-Westfalen
city: Bad Sobernheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Mainz
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Schoeneberg - Kuebelberg
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Bischofswerda
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Altenholz
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Bredstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Kiel
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Niebuell
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Lobenstein
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Rudolstadt
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
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.