This protocol posting describes the booster phase of the study. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00289731).
All subjects will receive a dose of the vaccine that they received in the primary study (100382), approximately 4 years after the first dose. Blood samples will be taken before and after the administration of the vaccine dose to evaluate the anti-HAV and anti-HBs antibody response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
213
GSK Investigational Site
Wilrijk, Belgium
GSK Investigational Site
Finsterwalde, Brandenburg, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Geringswalde, Saxony, Germany
Anti-HAV immune response to the challenge dose
Anti-HBs antibody response to the challenge dose
Percentage of subjects with anti-HAV antibody titres ≥ 15 mIU/ml and GMTs calculated on seropositive subjects
Time frame: Two weeks and one month after the challenge dose
Percentage of subjects with anti-HBs antibody titres ≥ 3.3 mIU/ml, ≥ 10 mIU/ml, ≥ 100 mIU/ml and anti-HBs GMTs calculated on seropositive subjects
Time frame: Two weeks and one month after the challenge dose
Occurrence and intensity of solicited local symptoms
Time frame: In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship of solicited general symptoms
Time frame: In the 4-day follow-up period after the challenge dose
Occurrence, intensity and relationship to vaccination of unsolicited symptoms reported
Time frame: During the 31-day follow-up period after the challenge dose
Occurrence of all serious adverse events (SAEs) reported
Time frame: Following the administration of the challenge dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
GSK Investigational Site
Pirna, Saxony, Germany
GSK Investigational Site
Bad Bramstedt, Schleswig-Holstein, Germany
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany
GSK Investigational Site
Elmshorn, Schleswig-Holstein, Germany