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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00411697
First received: December 13, 2006
Last updated: April 12, 2012
Last verified: April 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 301
Study Start Date: December 2006
Estimated Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Engerix™-B Kinder
Intramuscular injection, 1 dose
Other Name: Engerix™-B Kinder

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00411697     History of Changes
Other Study ID Numbers: 106789
Study First Received: December 13, 2006
Last Updated: April 12, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis B Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014