GSK: Protocol Summary for 112682

Home > Protocol Summaries: Compounds > Hepatitis B Vaccine, Recombinant > Protocol Summary for 112682

Protocol Summary for 112682

Protocol Summary
Protocol Id:	112682
Secondary Ids:	N/A
Title:	Long-term persistence of hepatitis B antibodies and immune response to a hepatitis B vaccine challenge in 12-13 year old adolescents, vaccinated in infancy with GlaxoSmithKline (GSK) Biologicals’ HBV vaccine (Engerix™-B)
Phase:	phase 4
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Germany: Paul-Ehrlich-Institut
Collaborators:	N/A
Brief Summary:	This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals’ recombinant hepatitis B vaccine (Engerix™-B) in infancy.
Detailed Description:
Record Verification Date:	March 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	October 2009
Study Completion Date:	April 2010
Study Completion Date Type:	Actual
Primary Completion Date:	April 2010
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:
Masking:	Open Label
Masked Subject:	no
Masked Caregiver:	no
Masked Investigator:	no
Masked Assessor:	no
Study Design (Assignment):	Single Group Assignment
Study Classification (Endpoint):	Efficacy Study
Primary Outcomes:	Anti-hepatitis B (Anti-HBs) antibody concentrations One month after the challenge dose of hepatitis B (HBV) vaccine
Secondary Outcomes:	Immune response to the study vaccine Before and one month after the challenge dose of HBV vaccine. Unsolicited adverse events During the 31-day (Day 0-30) follow-up period following the challenge dose vaccination Solicited local and general symptoms During the 4-day (Day 0-3) follow-up period following the challenge dose vaccination Serious adverse events After the challenge dose of the vaccine up to the study end.
Conditions:	Hepatitis B Vaccine Hepatitis B
Keywords:	persistence HBV Long-term Engerix™-B Kinder Hepatitis B adolescent
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: • Subjects who the investigator believes that their parent(s)/Legally Accepted representative (LAR(s)) can and will comply with the requirements of the protocol. • A male or female of 12 to 13 years of age at the time of enrolment. • With documented evidence of previous vaccination with three consecutive doses of Engerix-B in Germany: with the first two doses received by 9 months of age and the third dose received by 18 months of age. • Written informed consent obtained from the parent(s) or LAR(s) of the subject at the time of enrolment. • Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/LAR(s). • Healthy subjects as established by medical history and clinical examination before entering into the study. • Female subjects of non-childbearing potential may be enrolled in the study. • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination. 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 third dose of Engerix-B vaccine. • History of hepatitis B disease. • Hepatitis B vaccination at birth. • Adolescents living in institutional care. • Planned administration /administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before HBV vaccine challenge and ending 30 days after. • Administration of immunoglobulins and/or any blood products within the three months preceding HBV vaccine challenge or planned administration during the study period. • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the HBV vaccine challenge.. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the challenge dose of study vaccine, or planned use during the study period. • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions. • Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component. • Acute disease and/or fever at the time of enrolment.
Gender:	Both
Minimum Age:	12 Year
Maximum Age:	13 Year
Enrollment:	306
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information GERMANY (click to view all sites in GERMANY) GSK Investigational Site SCHWAEBISCH-HALL, BADEN-WUERTTEMBERG, 74523; COMPLETED; Contact: MICHAEL VOMSTEIN, Principal Investigator, . GSK Investigational Site TUTTLINGEN, BADEN-WUERTTEMBERG, 78532; COMPLETED; Contact: RALPH MAIER, Principal Investigator, . GSK Investigational Site STUTTGART, BADEN-WUERTTEMBERG, 70469; COMPLETED; Contact: ULRICH PFLETSCHINGER, Principal Investigator, . GSK Investigational Site MANNHEIM, BADEN-WUERTTEMBERG, 68163; COMPLETED; Contact: FALKO PANZER, Principal Investigator, . GSK Investigational Site KEHL, BADEN-WUERTTEMBERG, 77694; COMPLETED; Contact: ULRICH BEHRE, Principal Investigator, . GSK Investigational Site KIRCHHEIM, BAYERN, 85551; COMPLETED; Contact: FRANZISKUS SCHUHBOECK, Principal Investigator, . GSK Investigational Site BINDLACH, BAYERN, 95463; COMPLETED; Contact: NORBERT MEISTER, Principal Investigator, . GSK Investigational Site KEMPTEN, BAYERN, 87435; COMPLETED; Contact: RUDOLF KAPPES, Principal Investigator, . GSK Investigational Site MUENCHEN, BAYERN, 81735; COMPLETED; Contact: CARL W BAUKHAGE, Principal Investigator, . GSK Investigational Site GILCHING, BAYERN, 82205; COMPLETED; Contact: MANFRED PRAUN, Principal Investigator, . GSK Investigational Site CHAM, BAYERN, 93413; COMPLETED; Contact: THOMAS HABASH, Principal Investigator, . GSK Investigational Site BERLIN, BERLIN, 10967; COMPLETED; Contact: KLAUS-JUERGEN TAUBE, Principal Investigator, . GSK Investigational Site BERLIN, BERLIN, 13055; COMPLETED; Contact: UTA WALTHER, Principal Investigator, . GSK Investigational Site BERLIN, BERLIN, 10315; COMPLETED; Contact: URSULA HOERNLEIN, Principal Investigator, . GSK Investigational Site BRAUNATAL, HESSEN, 34225; COMPLETED; Contact: GERHARD BLECKMANN, Principal Investigator, . GSK Investigational Site MUENSTER, NORDRHEIN-WESTFALEN, 48163; COMPLETED; Contact: PHILIP FELLNER VON FELDEGG, Principal Investigator, . GSK Investigational Site DUISBURG, NORDRHEIN-WESTFALEN, 47137; COMPLETED; Contact: HARALD KRAL, Principal Investigator, . GSK Investigational Site FRANKENTHAL, RHEINLAND-PFALZ, 67227; COMPLETED; Contact: LOTHAR MAURER, Principal Investigator, . GSK Investigational Site WORMS, RHEINLAND-PFALZ, 67547; COMPLETED; Contact: CHRISTOPH SIEVERS, Principal Investigator, . GSK Investigational Site WEIMAR, THUERINGEN, 99425; COMPLETED; Contact: MONIKA NIEHAUS, Principal Investigator, .

Quick Search

Protocol Summary for 112682