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Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197184
First received: September 15, 2005
Last updated: October 21, 2016
Last verified: October 2016
  Purpose

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Hepatitis B Hepatitis A Biological: Twinrix™ Adult Biological: Twinrix™ Junior Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluate the Persistence of Immune Response of GSK Biologicals' Twinrix™ Vaccine, Administered According to a 0,6 Month Schedule and a 0,1,6 Month Schedule, in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-hepatitis A (HAV) Antibody Concentrations [ Time Frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) ]
    Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)

  • Anti-hepatitis B (HBs) Antibody Concentrations [ Time Frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60) ]
    Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).

  • Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. [ Time Frame: Before and one month after additional vaccination ]
    Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres < 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.

  • Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose. [ Time Frame: Before and One month after additional vaccination ]
    Subjects losing seroprotective anti-HBs antibody titres (i.e. titres < 10 mIU/ml) at any long term time point, received an Engerix™ challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).


Secondary Outcome Measures:
  • Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy. [ Time Frame: From last study visit of the primary study up to Year 5 long term follow-up ]

    A serious adverse event (SAE) is any untoward medical occurrence that:

    results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.


  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms [ Time Frame: during the 4-day follow-up period after additional vaccination ]

    Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site.

    Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful


  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms. [ Time Frame: During the 4-day follow-up period after additional vaccination ]

    Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache.

    Any= regardless of intensity grade or relationship to vaccination; grade 3= prevented normal activity; Related= considered by the investigator to be causally related to the vaccination


  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs). [ Time Frame: During the 30-day follow-up period after additional vaccination. ]
    An Adverse Event is 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 Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events [ Time Frame: At least one month after additional vaccination ]

    A serious adverse event (SAE) is any untoward medical occurrence that:

    results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.



Enrollment: 276
Study Start Date: November 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Twinrix Junior
Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
Biological: Twinrix™ Junior
Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
Other Name: Combined hepatitis A and B vaccine
Active Comparator: Twinrix Adult
Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
Biological: Twinrix™ Adult
Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
Other Name: Combined hepatitis A and B vaccine

Detailed Description:
Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence studies. Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence. No additional subjects will be recruited during the long term follow-up period.
  Eligibility

Ages Eligible for Study:   3 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in primary study
  • Written informed consent obtained before each long term follow up visit.
  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: NCT00197184

Locations
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Belgium
GSK Investigational Site
Bruxelles, Belgium, 1200
Spain
GSK Investigational Site
Barcelona, Spain, 08042
GSK Investigational Site
Blanes (Girona), Spain, 17300
GSK Investigational Site
Cerdanyola del Vallés / Barcelona, Spain, 08290
GSK Investigational Site
Valencia, Spain, 46024
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 208127/132 (EXT Y2)
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 208127/132 (EXT Y2)
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 208127/132 (EXT Y2)
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: 208127/132 (EXT Y2)
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 208127/132 (EXT Y2)
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: 208127/132 (EXT Y2)
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 208127/132 are summarised with studies 208122/133, 208127/134 and 208127/137 on the GSK Clinical Study Register.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197184     History of Changes
Obsolete Identifiers: NCT00787449
Other Study ID Numbers: 208127/132 (EXT Y2)
208127/133 (EXT Y3) ( Other Identifier: GSK )
208127/134 (EXT Y4) ( Other Identifier: GSK )
208127/137 (EXT Y5) ( Other Identifier: GSK )
Study First Received: September 15, 2005
Results First Received: February 20, 2009
Last Updated: October 21, 2016
Individual Participant Data (IPD) Sharing Statement:
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:
Combined hepatitis A and B vaccine
Twinrix™

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 August 21, 2017