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

September 14, 2005
November 3, 2011
April 2004
January 2008   (final data collection date for primary outcome measure)
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.

Persistence of anti-HBs antibodies at Months 30, 42, 54 and 66 after the first dose of the vaccination.
Complete list of historical versions of study NCT00343915 on ClinicalTrials.gov Archive Site
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 ]
To record the SAEs that was reported since the last timepoint
Not Provided
Not Provided
 
Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
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

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.

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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Prophylaxis Hepatitis B
  • Biological: Engerix™-B (thiomersal-free) 20µg
    In the primary study: 2 deep intramuscular injections (Months 0, & 6)
  • Biological: 10 μg Engerix™-B (preservative-free)
    In the primary study: 3 deep intramuscular injections (months 0, 1 & 6)
  • Biological: placebo
    In the primary study: 1 deep intramuscular injection (month 1)
  • 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.
    Interventions:
    • Biological: Engerix™-B (thiomersal-free) 20µg
    • Biological: placebo
  • Active Comparator: 3-Dose Engerix
    subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
    Intervention: Biological: 10 μg Engerix™-B (preservative-free)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
267
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
13 Years to 20 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Ukraine
 
NCT00343915
101695 Ext. Mth30, 101696, 101697, 101698
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP