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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
  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
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 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 267
Study Start Date: April 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (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   (Child, Adult)
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
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
GSK Investigational Site
Wilrijk, Belgium, 2610
Ukraine
GSK Investigational Site
Kyiv, Ukraine, 03038
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 101695 Ext. Mth30
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 101695 Ext. Mth30
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 101695 Ext. Mth30
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 101695 Ext. Mth30
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 101695 (Ext HBV-280 M30) are summarised with studies 103860/280 (HBV-280), 101696 (Ext HBV-280 M42), 101697 (Ext HBV-280 M54) and 101698
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 101695 Ext. Mth30
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
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: September 29, 2016
Health Authority: Australia: Human Research Ethics Committee
Individual Participant Data  
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.

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016