Trial record 8 of 33 for:    Thimerosal

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
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 April 17, 2014