Clinical trial NCT00411697: Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
Official title: Assess Long-term Persistence of Hepatitis B Antibodies & Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Aged 4-5 Years (Previously Primed & Boosted in the 1st 2 Years of Life With DTPa-HBV-IPV/Hib Vaccine)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-14
Enrollment: 301
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine at 5 years of age the persistence of immunity to hepatitis B that was conferred by infant vaccination with Infanrix hexa™.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
* A male or female of 4 to 5 years of age at the time of enrolment.
* With documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ in Germany.
* Written informed consent obtained from the parents or guardians of the subject at the time of enrolment.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product .
* Evidence of previous hepatitis B booster vaccination since administration of the fourth dose of Infanrix hexa™ booster in the second year of life.
* History of or intercurrent hepatitis B disease.
* Hepatitis B vaccination at birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before booster vaccination and ending 30 days after.
* Administration of immunoglobulins and/or any blood products within the three months preceding booster vaccination or planned administration during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.

Primary outcomes:
measure: Anti-hepatitis B surface antigen (HBs) antibody concentrations
timeFrame: One month after the challenge dose of HBV vaccine
Secondary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Before and after challenge dose of HBV vaccine
measure: Occurrence of serious adverse events
timeFrame: During the entire study period.
Other outcomes:
Locations:
city: Bad Saulgau
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bietigheim/Bissingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Boennigheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ehingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Ettenheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Herbolzheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kehl
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Kirchzarten
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Oberstenfeld
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Offenburg
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Pforzheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tettnang
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Tuttlingen
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Aschaffenburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Cham
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: Olching
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Tegernsee
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Dudenhofen
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Frankenthal
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Gau-Odernheim
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Gerolstein
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: Trier
country: Germany
facility: GSK Investigational Site
state: Rheinland-Pfalz
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
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: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Steiner M, Ramakrishnan G, Gartner B, Van Der Meeren O, Jacquet JM, Schuster V. Lasting immune memory against hepatitis B in children after primary immunization with 4 doses of DTPa-HBV-IPV/Hib in the first and 2nd year of life. BMC Infect Dis. 2010 Jan 15;10:9. doi: 10.1186/1471-2334-10-9.