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Persistence of Hepatitis B Antibody Levels & Immune Response to a Hepatitis B Vaccine Challenge

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00411697
  Purpose

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.


Condition Intervention Phase
Hepatitis B
Biological: Engerix™-B Kinder
Phase IV

MedlinePlus related topics:   Hepatitis    Hepatitis B   

ChemIDplus related topics:   Hepatitis B Vaccines   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-hepatitis B surface antigen (HBs) antibody concentrations [ Time Frame: One month after the challenge dose of HBV vaccine ]

Secondary Outcome Measures:
  • Anti-HBs antibody concentrations [ Time Frame: Before and after challenge dose of HBV vaccine ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period. ]

Enrollment:   301
Study Start Date:   December 2006
Primary Completion Date:   May 2007 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Group A: Experimental Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose

  Eligibility
Ages Eligible for Study:   4 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411697

Locations
Germany
GSK Investigational Site    
      Berlin, Germany, 13355
GSK Investigational Site    
      Berlin, Germany, 13055
GSK Investigational Site    
      Berlin, Germany, 12679
GSK Investigational Site    
      Berlin, Germany, 13507
GSK Investigational Site    
      Berlin, Germany, 10315
Germany, Baden-Wuerttemberg
GSK Investigational Site    
      Boennigheim, Baden-Wuerttemberg, Germany, 74357
GSK Investigational Site    
      Offenburg, Baden-Wuerttemberg, Germany, 77654
GSK Investigational Site    
      Stuttgart, Baden-Wuerttemberg, Germany, 70469
GSK Investigational Site    
      Ehingen, Baden-Wuerttemberg, Germany, 89584
GSK Investigational Site    
      Tettnang, Baden-Wuerttemberg, Germany, 88069
GSK Investigational Site    
      Tuttlingen, Baden-Wuerttemberg, Germany, 78532
GSK Investigational Site    
      Kehl, Baden-Wuerttemberg, Germany, 77694
GSK Investigational Site    
      Ettenheim, Baden-Wuerttemberg, Germany, 77955
GSK Investigational Site    
      Bietigheim/Bissingen, Baden-Wuerttemberg, Germany, 74321
GSK Investigational Site    
      Pforzheim, Baden-Wuerttemberg, Germany, 75172
GSK Investigational Site    
      Oberstenfeld, Baden-Wuerttemberg, Germany, 71720
GSK Investigational Site    
      Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
GSK Investigational Site    
      Kirchzarten, Baden-Wuerttemberg, Germany, 79199
Germany, Bayern
GSK Investigational Site    
      Cham, Bayern, Germany, 93413
GSK Investigational Site    
      Olching, Bayern, Germany, 82140
GSK Investigational Site    
      Muenchen, Bayern, Germany, 81241
GSK Investigational Site    
      Muenchen, Bayern, Germany, 81735
GSK Investigational Site    
      Tegernsee, Bayern, Germany, 83684
Germany, Rheinland-Pfalz
GSK Investigational Site    
      Trier, Rheinland-Pfalz, Germany, 54294
GSK Investigational Site    
      Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site    
      Frankenthal, Rheinland-Pfalz, Germany, 67227
Germany, Sachsen
GSK Investigational Site    
      Leipzig, Sachsen, Germany, 04317

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
  More Information


Responsible Party:   GSK ( Study Director )
Study ID Numbers:   106789
First Received:   December 13, 2006
Last Updated:   October 9, 2008
ClinicalTrials.gov Identifier:   NCT00411697
Health Authority:   Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Antibodies
Liver Diseases
Digestive System Diseases
Hepatitis B Antibodies
Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Hepadnaviridae Infections
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 15, 2008




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