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Clinical Trials/EUCTR2007-002221-76-DE
EUCTR2007-002221-76-DE
Active, not recruiting
Not Applicable

An open, phase IV, single-group, multicentre study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B (HBV) vaccine challenge in children aged 7-8 years of age and previously vaccinated in infancy with GSK Biologicals’ HBV vaccine (Engerix™-B). - HBV-315 PRI

GSK Biologicals0 sitesJune 18, 2007
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ConditionsAntibody persistence and hepatitis B vaccine challenge in children 7-8 years of age, previously vaccinated with 3 doses of GSK Biologicals’ HBV vaccine in routine vaccination practice in Germany.
DrugsEngerix-B Kinder

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antibody persistence and hepatitis B vaccine challenge in children 7-8 years of age, previously vaccinated with 3 doses of GSK Biologicals’ HBV vaccine in routine vaccination practice in Germany.
Sponsor
GSK Biologicals
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 18, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
GSK Biologicals

Eligibility Criteria

Inclusion Criteria

  • •A male or female of 7 to 8 years of age (from and including the 7th birthday up to but excluding the 9th birthday) 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 parents or guardians of the subject at the time of enrolment.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

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 (pharmaceutical product or device).
  • •Evidence of previous hepatitis B booster vaccination since administration of the third dose of Engerix™\-B vaccine.
  • •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Outcomes

Primary Outcomes

Not specified

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