Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343915
First received: September 14, 2005
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.

Subjects were aged 11 to 15 years at the time of the primary vaccination course.

At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Prophylaxis Hepatitis B
Biological: Engerix™-B (thiomersal-free) 20µg
Biological: 10 μg Engerix™-B (preservative-free)
Biological: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Long-term Study of Immune Response Persistence of GSK Biologicals' 2-dose Thiomersal-free Engerix™-B and 3-dose Preservative-free Engerix™-B Vaccines in Subjects Aged 11-15 Yrs

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Anti-hepatitis B Surface Antigen (Anti-HBs) Seroprotected Subjects [ Time Frame: At Months 30, 42, 54 & 66 ] [ Designated as safety issue: No ]

    The number of seroprotected subjects (i.e. with anti-HBs antibody concentrations ≥ 10 mIU/ml) is given for each respective follow-up timepoint.

    The total number of subjects analysed (N) is given for both groups between brackets in the category titles.



Secondary Outcome Measures:
  • Occurrence of Serious Adverse Events Determined by the Investigators to Have a Causal Relationship to Vaccination or to Study Procedures [ Time Frame: At Months 30, 42, 54 & 66 ] [ Designated as safety issue: Yes ]

Enrollment: 267
Study Start Date: April 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2-Dose Engerix
subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
Biological: Engerix™-B (thiomersal-free) 20µg
In the primary study: 2 deep intramuscular injections (Months 0, & 6)
Biological: placebo
In the primary study: 1 deep intramuscular injection (month 1)
Active Comparator: 3-Dose Engerix
subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
Biological: 10 μg Engerix™-B (preservative-free)
In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)

Detailed Description:

All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects have participated in primary study HBV-280
  • Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year
  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: NCT00343915

Locations
Australia, New South Wales
GSK Investigational Site
Sydney, New South Wales, Australia
Ukraine
GSK Investigational Site
Kyiv, Ukraine, 03038
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Heron LG et al. A novel hepatitis B vaccination regimen for adolescents - 2 doses 12 months apart. Abstract presented at the 10th ICID Singapore, Bangkok, March 2002.
Heron L et al. Randomised control trial: 2-vs 3-dose hepatitis B immunization of adolescents. Abstract presented at the 12th International Symposium on Viral Hepatitis and Liver Disease (ISVHLD), Paris, France, 1-5 July 2006.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00343915     History of Changes
Obsolete Identifiers: NCT00787228
Other Study ID Numbers: 101695 Ext. Mth30, 101696, 101697, 101698
Study First Received: September 14, 2005
Results First Received: December 23, 2008
Last Updated: November 3, 2011
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by GlaxoSmithKline:
Persistence
Hepatitis B vaccine

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

ClinicalTrials.gov processed this record on August 18, 2014