GSK: Protocol Summary for 112688

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Protocol Summary for 112688

Protocol Summary
Protocol Id:	112688
Secondary Ids:
Title:	Long-term antibody persistence of hepatitis B antibodies and immune response to a hepatitis B vaccine (Engerix-B Kinder) challenge in children previously vaccinated with Infanrix hexa 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:
Brief Summary:	This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.
Detailed Description:
Record Verification Date:	July 2012
Status:	Completed
Why Study Stopped:
Study Start Date:	April 2011
Study Completion Date:	September 2011
Study Completion Date Type:	Actual
Primary Completion Date:	September 2011
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	N\A
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:	Immunogenicity with respect to components of the study vaccine in terms of number of subjects with anti-HBs antibody concentrations equal to or above cut-off value One month (Month 1) after a challenge dose of Engerix-BTM Kinder vaccine
Secondary Outcomes:	Immunogenicity to the components of the study vaccine in terms of number of subjects with anti-HBs antibody concentrations equal to or above cut-off values and concentrations One month (Month 1) after a challenge dose of Engerix-BTM Kinder vaccine Anti-HBs antibody persistence after previous vaccination with Infanrix hexaTM in terms of number of subjects with anti-HBs antibody concentrations equal to or above cut-off values and concentrations Before (Day 0) a challenge dose of Engerix-BTM Kinder vaccine Number of subjects with unsolicited adverse events During the 31-day (Day 0-30) follow-up period after the challenge dose of Engerix-BTM Kinder vaccine Number of subjects with serious adverse events After the challenge dose of Engerix-BTM Kinder vaccine up to the study end (Day 0 to Month 1). Number of subjects with solicited local and general symptoms During the 4-day (Day 0-3) follow-up period after the challenge dose of Engerix-BTM Kinder vaccine
Conditions:	Hepatitis B
Keywords:	Engerix-BTM Kinder immune response Persistence challenge dose
Eligibility Criteria:	Click to view inclusion/exclusion criteria Inclusion Criteria: • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol. • A male or female 7 to 8 years of age at the time of enrolment. • Subjects with documented evidence of previous vaccination with four consecutive doses of Infanrix hexa™ as part of routine vaccination in Germany: three doses of primary vaccination received by 9 months of age and one booster dose received between 11 and 18 months of age. • Written informed consent obtained from the parents/Legally Acceptable Representative(s) of the subject at the time of enrolment. • In addition to the informed consent that will be signed by the parent(s)/Legally Acceptable Representative(s), written informed assent of the subject will be sought when the subject is judged able to understand by the investigator. • Healthy subjects as established by medical history and clinical examination before entering into the study. Exclusion Criteria: • Child in care • Use of any investigational or non-registered product, other than the study vaccine, within 30 days preceding the dose of study vaccine, or planned use during the study period. • 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 hexaTM 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 and ending 30 days after the hepatitis B vaccine challenge dose. • Administration of immunoglobulins and/or any blood products within the three months preceding challenge dose or planned administration during the study period. • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the hepatitis B vaccine, or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • Acute disease and/or fever at the time of enrolment.
Gender:	Both
Minimum Age:	7 Year
Maximum Age:	8 Year
Enrollment:	300
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 Stuttgart, Baden-Wuerttemberg, 70469; COMPLETED; Contact: Ulrich Pfletschinger, Principal Investigator, . GSK Investigational Site Kehl, Baden-Wuerttemberg, 77694; COMPLETED; Contact: Ulrich Behre, Principal Investigator, . GSK Investigational Site Bad Saulgau, Baden-Wuerttemberg, 88348; COMPLETED; Contact: Michael Steiner, Principal Investigator, . GSK Investigational Site Oberstenfeld, Baden-Wuerttemberg, 71720; COMPLETED; Contact: Martin Kimmig, Principal Investigator, . GSK Investigational Site Tuttlingen, Baden-Wuerttemberg, 78532; COMPLETED; Contact: Ralph Maier, Principal Investigator, . GSK Investigational Site Kempten, Bayern, 87435; COMPLETED; Contact: Thomas Potthast, Principal Investigator, . GSK Investigational Site Bindlach, Bayern, 95463; COMPLETED; Contact: Norbert Meister, Principal Investigator, . GSK Investigational Site Berlin, Berlin, 13055; COMPLETED; Contact: Uta Walther, Principal Investigator, . GSK Investigational Site Braunatal, Hessen, 34225; COMPLETED; Contact: Gerhardt Bleckmann, Principal Investigator, . GSK Investigational Site Muenster, Nordrhein-Westfalen, 48163; COMPLETED; Contact: Philip Fellner von Feldegg, Principal Investigator, . GSK Investigational Site Worms, Rheinland-Pfalz, 67547; COMPLETED; Contact: Christoph Sievers, Principal Investigator, . GSK Investigational Site Frankenthal, Rheinland-Pfalz, 67227; COMPLETED; Contact: Lothar Maurer, Principal Investigator, .

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Protocol Summary for 112688