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Tracking Information | |||||
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First Received Date † | December 13, 2006 | ||||
Last Updated Date | October 16, 2008 | ||||
Start Date † | December 2006 | ||||
Current Primary Outcome Measures † |
Anti-hepatitis B surface antigen (HBs) antibody concentrations [ Time Frame: One month after the challenge dose of HBV vaccine ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00411697 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
Anti-HBs antibody concentrations before the HBV challenge dose. | ||||
Descriptive Information | |||||
Brief Title † | 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 Yrs (Previously Primed & Boosted in the 1st 2 Yrs of Life With DTPa-HBV-IPV/Hib Vaccine) | ||||
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. |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study | ||||
Condition † | Hepatitis B | ||||
Intervention † | Biological: Engerix™-B Kinder | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 301 | ||||
Completion Date | May 2007 | ||||
Primary Completion Date | May 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 4 Years to 5 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Germany | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00411697 | ||||
Responsible Party | Study Director, GSK | ||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | October 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |