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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
276
Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.
Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
GSK Investigational Site
North Adelaide, South Australia, Australia
GSK Investigational Site
Carlton, Victoria, Australia
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Barcelona, Spain
Anti-hepatitis A (HAV) Antibody Concentrations
Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)
Time frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Anti-hepatitis B (HBs) Antibody Concentrations
Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).
Time frame: Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)
Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
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.
Time frame: Before and one month after additional vaccination
Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.
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).
Time frame: Before and One month after additional vaccination
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.
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.
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GSK Investigational Site
Blanes (Girona), Spain
GSK Investigational Site
Cerdanyola Del Vallés / Barcelona, Spain
GSK Investigational Site
Valencia, Spain
Time frame: From last study visit of the primary study up to Year 5 long term follow-up
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling at the vaccine injection site. Any= regardless of intensity grade; Grade 3 Pain= spontaneously painful
Time frame: during the 4-day follow-up period after additional vaccination
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.
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
Time frame: During the 4-day follow-up period after additional vaccination
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).
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.
Time frame: During the 30-day follow-up period after additional vaccination.
Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events
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.
Time frame: At least one month after additional vaccination