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Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
This study has been completed.
Study NCT00411697   Information provided by GlaxoSmithKline
First Received: December 13, 2006   Last Updated: October 16, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

December 13, 2006
October 16, 2008
December 2006
Anti-hepatitis B surface antigen (HBs) antibody concentrations [ Time Frame: One month after the challenge dose of HBV vaccine ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00411697 on ClinicalTrials.gov Archive Site
  • Anti-HBs antibody concentrations [ Time Frame: Before and after challenge dose of HBV vaccine ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period. ] [ Designated as safety issue: Yes ]
Anti-HBs antibody concentrations before the HBV challenge dose.
 
Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge
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)

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.

 
Phase IV
Interventional
Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
Hepatitis B
Biological: Engerix™-B Kinder
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
301
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
4 Years to 5 Years
Yes
 
Germany
 
 
NCT00411697
Study Director, GSK
 
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.