Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343915
Recruitment Status : Completed
First Posted : June 23, 2006
Results First Posted : March 31, 2009
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE June 23, 2006
Results First Submitted Date  ICMJE December 23, 2008
Results First Posted Date  ICMJE March 31, 2009
Last Update Posted Date June 10, 2019
Actual Study Start Date  ICMJE April 21, 2004
Actual Primary Completion Date January 10, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Number of Subjects Seroprotected for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody. [ Time Frame: At Month 7 ]
    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 ]
    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 ]
    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2006)
Persistence of anti-HBs antibodies at Months 30, 42, 54 and 66 after the first dose of the vaccination.
Change History Complete list of historical versions of study NCT00343915 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 29, 2016)
  • Antibody Titers Against Hepatitis-B Virus. [ Time Frame: At Months 1, 2, 6 and 7 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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) ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2006)
To record the SAEs that was reported since the last timepoint
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs
Official Title  ICMJE 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
Brief Summary

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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hepatitis B
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
267
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE January 10, 2008
Actual Primary Completion Date January 10, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00343915
Other Study ID Numbers  ICMJE 101695 Ext. Mth30
101696 ( Other Identifier: GSK )
101697 ( Other Identifier: GSK )
101698 ( Other Identifier: GSK )
2015-001531-20 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date February 2019

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