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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

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ClinicalTrials.gov Identifier: NCT00197184
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 4, 2009
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE September 15, 2005
First Posted Date  ICMJE September 20, 2005
Results First Submitted Date  ICMJE February 20, 2009
Results First Posted Date  ICMJE June 4, 2009
Last Update Posted Date August 20, 2018
Study Start Date  ICMJE November 1, 2003
Actual Primary Completion Date March 10, 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2011)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs,2,3,4 and 5 yrs after administration of 1st vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 5 time point) to subject
Change History Complete list of historical versions of study NCT00197184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2005)
To record the SAEs that was reported since the last time point.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatitis B
  • Hepatitis A
Intervention  ICMJE
  • Biological: Twinrix™ Adult
    Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
    Other Name: Combined hepatitis A and B vaccine
  • Biological: Twinrix™ Junior
    Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
    Other Name: Combined hepatitis A and B vaccine
Study Arms  ICMJE
  • Experimental: Twinrix Junior
    Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
    Intervention: Biological: Twinrix™ Junior
  • Active Comparator: Twinrix Adult
    Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
    Intervention: Biological: Twinrix™ Adult
Publications * Marshall H, Nolan T, Díez Domingo J, Rombo L, Sokal EM, Marès J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29.

*   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: August 11, 2008)
276
Original Enrollment  ICMJE
 (submitted: September 15, 2005)
511
Actual Study Completion Date  ICMJE March 10, 2004
Actual Primary Completion Date March 10, 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Participation in primary study
  • Written informed consent obtained before each long term follow up visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 13 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00197184
Other Study ID Numbers  ICMJE 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 )
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 October 2016

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