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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 (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343915
First received: September 14, 2005
Last updated: September 29, 2016
Last verified: September 2016

September 14, 2005
September 29, 2016
April 2004
December 2004   (final data collection date for primary outcome measure)
  • Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. [ Time Frame: At Month 7 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
  • Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. [ Time Frame: At Month 30, Month 42, Month 54 and Month 66 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
  • Antibody Titers Against Hepatitis-B Virus. [ Time Frame: At Month 30, Month 42, Month 54 and Month 66 ] [ Designated as safety issue: No ]
    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
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
  • Antibody Titers Against Hepatitis-B Virus. [ Time Frame: At Months 1, 2, 6 and 7 ] [ Designated as safety issue: No ]
    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
  • Number of Subjects Seroprotected for Anti-HBs Antibody. [ Time Frame: At Months 1, 2 and 6 ] [ Designated as safety issue: No ]
    A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall ] [ Designated as safety issue: No ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: During the 4-day (Day 0-3) follow-up period after each vaccination and overall ] [ Designated as safety issue: No ]
    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, and fever. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Gastrointestinal symptoms included nausea, vomiting, diarrhea and abdominal pain. Grade 3 fever was defined as fever (axillary temperature) > 38.5°C. Grade 3 symptoms were defined as symptoms which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
  • Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AE). [ Time Frame: During the 31-day (Day 0-30) follow-up period after each vaccination and overall ] [ Designated as safety issue: No ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Month 0 to Month 66) ] [ Designated as safety issue: No ]
    Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
  • Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: At Month 30, Month 42, Month 54 & Month 66 ] [ Designated as safety issue: Yes ]
    erious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
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
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
December 2004
December 2004   (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   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Ukraine
 
NCT00343915
101695 Ext. Mth30, 101696, 101697, 101698
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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