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

• 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) ] [ Designated as safety issue: No ]
  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) ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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).
  
  

• 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 ] [ Designated as safety issue: No ]

  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 ] [ Designated as safety issue: No ]

  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 ] [ Designated as safety issue: No ]

  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. ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]

  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.

  
  

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.