Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

Condition(s) targeted: Hepatitis B

Intervention: hepatitis B vaccine (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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

Official title: Multicentre Study to Assess Persistence of Antibodies Against Hepatitis B & Immune Response to a Hepatitis B Challenge Dose in Healthy Children 4 to 6 Yrs Old Previously Vaccinated With 4 Doses of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Anti-HBs antibody concentration

Secondary outcome:

Persistence of antibodies to the other DTPa-HBV-IPV/Hib vaccine antigens.

Sol & unsol symptoms after HBV vaccination, SAEs

Minimum age: 4 Years. Maximum age: 6 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

GSK Investigational Site, Berlin 10315, Germany

GSK Investigational Site, Berlin 12627, Germany

GSK Investigational Site, Berlin 13355, Germany

GSK Investigational Site, Bad Saulgau, Baden-Wuerttemberg 88348, Germany

GSK Investigational Site, Boennigheim, Baden-Wuerttemberg 74357, Germany

GSK Investigational Site, Ettenheim, Baden-Wuerttemberg 77955, Germany

GSK Investigational Site, Kehl, Baden-Wuerttemberg 77694, Germany

GSK Investigational Site, Offenburg, Baden-Wuerttemberg 77654, Germany

GSK Investigational Site, Schwaebisch-Hall, Baden-Wuerttemberg 74523, Germany

GSK Investigational Site, Stuttgart, Baden-Wuerttemberg 70469, Germany

GSK Investigational Site, Tuttlingen, Baden-Wuerttemberg 78532, Germany

GSK Investigational Site, Cham, Bayern 93413, Germany

GSK Investigational Site, Freising, Bayern 85354, Germany

GSK Investigational Site, Kaufering, Bayern 86916, Germany

GSK Investigational Site, Landsberg, Bayern 86899, Germany

GSK Investigational Site, Muenchen, Bayern 80939, Germany

GSK Investigational Site, Muenchen, Bayern 81241, Germany

GSK Investigational Site, Muenchen, Bayern 81735, Germany

GSK Investigational Site, Noerdlingen, Bayern 86720, Germany

GSK Investigational Site, Tutzing, Bayern 82327, Germany

GSK Investigational Site, Weilheim, Bayern 82362, Germany

GSK Investigational Site, Waren, Mecklenburg-Vorpommern 17192, Germany

GSK Investigational Site, Salzgitter, Niedersachsen 38226, Germany

GSK Investigational Site, Erkrath, Nordrhein-Westfalen 40699, Germany

GSK Investigational Site, Heiligenhaus, Nordrhein-Westfalen 42579, Germany

GSK Investigational Site, Kleve-Materborn, Nordrhein-Westfalen 47533, Germany

GSK Investigational Site, Krefeld, Nordrhein-Westfalen 47798, Germany

GSK Investigational Site, Willich, Nordrhein-Westfalen 47877, Germany

GSK Investigational Site, Schoeneberg - Kuebelberg, Rheinland-Pfalz 66901, Germany

GSK Investigational Site, Trier, Rheinland-Pfalz 54290, Germany

GSK Investigational Site, Trier, Rheinland-Pfalz 54294, 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

Related publications:

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. Epub .

Disselhoff J et al. Immune memory against hepatitis B persists in 4-6 year olds previously vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine. Abstract presented at the 26th annual meeting of the European Society for Paediatric Infectious Diseases (ESPID), Graz, Austria, 13-17 May 2008

Starting date: June 2006
Last updated: November 21, 2012