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Protocol Summary for 106789

Protocol Summary
Protocol Id:	106789
Secondary Ids:	N/A
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 yrs (previously primed & boosted in the 1st 2 yrs of life with DTPa-HBV-IPV/Hib vaccine)
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:
Detailed Description:
Record Verification Date:	September 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	December 2006
Study Completion Date:	May 2007
Study Completion Date Type:
Primary Completion Date:	May 2007
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Non-randomized
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 surface antigen (HBs) antibody concentrations One month after the challenge dose of HBV vaccine
Secondary Outcomes:	Occurrence of serious adverse events yes During the entire study period. Anti-HBs antibody concentrations Before and after challenge dose of HBV vaccine
Conditions:	Hepatitis B
Keywords:
Eligibility Criteria:	Click to view inclusion/exclusion 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.
Gender:	Both
Minimum Age:	4 Year
Maximum Age:	5 Year
Enrollment:	301
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 Ettenheim, Baden-Wuerttemberg, 77955; Completed; GSK Investigational Site Pforzheim, Baden-Wuerttemberg, 75172; Completed; GSK Investigational Site Kirchzarten, Baden-Wuerttemberg, 79199; Completed; GSK Investigational Site Tettnang, Baden-Wuerttemberg, 88069; Completed; GSK Investigational Site Ehingen, Baden-Wuerttemberg, 89584; Completed; GSK Investigational Site Boennigheim, Baden-Wuerttemberg, 74357; Completed; GSK Investigational Site Kehl, Baden-Wuerttemberg, 77694; Completed; GSK Investigational Site Bad Saulgau, Baden-Wuerttemberg, 88348; Completed; GSK Investigational Site Oberstenfeld, Baden-Wuerttemberg, 71720; Completed; GSK Investigational Site Bietigheim/Bissingen, Baden-Wuerttemberg, 74321; Completed; GSK Investigational Site Offenburg, Baden-Wuerttemberg, 77654; Completed; GSK Investigational Site Tuttlingen, Baden-Wuerttemberg, 78532; Completed; GSK Investigational Site Stuttgart, Baden-Wuerttemberg, 70469; Completed; GSK Investigational Site Tegernsee, Bayern, 83684; Completed; GSK Investigational Site Muenchen, Bayern, 81241; Completed; GSK Investigational Site Muenchen, Bayern, 81735; Completed; GSK Investigational Site Olching, Bayern, 82140; Completed; GSK Investigational Site Cham, Bayern, 93413; Completed; GSK Investigational Site Berlin, Berlin, 13355; Completed; GSK Investigational Site Berlin, Berlin, 12679; Completed; GSK Investigational Site Berlin, Berlin, 13055; Completed; GSK Investigational Site Berlin, Berlin, 10315; Completed; GSK Investigational Site Berlin, Berlin, 13507; Completed; GSK Investigational Site Frankenthal, Rheinland-Pfalz, 67227; Completed; GSK Investigational Site Trier, Rheinland-Pfalz, 54294; Completed; GSK Investigational Site Trier, Rheinland-Pfalz, 54290; Completed; GSK Investigational Site Leipzig, Sachsen, 04317; Completed;

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Protocol Summary for 106789