Long-Term Immune Persistence of GlaxoSmithKline Biologicals' Inactivated Hepatitis A Vaccine Injected According to a 0, 12-month Schedule

Concentrations given as geometric mean concentration (GMC) expressed as milli-international unit per millilitre (mIU/mL). \*\* = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.

Time frame: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Population: Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint.~\* The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.

A seropositive subject was a vaccinated subject whose concentrations for antibodies against hepatitis A virus (anti-HAV) were equal or above (\>=) the assay cut-off for seropositivity of 15 milli-international units per milliliter (mIU/mL). \*\* = Regarding Month 234 data, please note that there were 5 subjects for whom serum sample tube was broken and thus due to risk of contamination the test were not performed. Hence these subjects were not included in the LT-ATP cohort for immunogenicity analysis at Month 234. $ = Regarding Month 246 data, please note there was 1 subject for whom serum sample tube was broken and hence scrapped by laboratory. Hence this subject was not included in the LT-ATP cohort for immunogenicity analysis at Month 246.

Time frame: At Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Population: Analysis was performed on the Long Term According-to-Protocol (LT-ATP) cohort for analysis of immunogenicity, on subjects with available data for the defined timepoint. \*The laboratory assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.

Concentrations given as GMC expressed as mIU/mL. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198. Please note that value 14.9 means \<15.

Time frame: Before additional vaccination, 14 days after additional vaccination and 30 days after additional vaccination

Population: Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (\< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

The number of subjects with outcome of pregnancies reported among subjects who had received the additional vaccination was tabulated. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

Time frame: At Months 186 and 198

Population: Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (\< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

An 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.

Time frame: During the 30-day follow-up period after additional vaccination

Population: Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (\< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

An 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 Months 138, 150, 162, 174, 186, 198, 210, 222, 234 and 246

Population: Analysis was performed on the Long Term Total cohort, on subjects with available data for the defined timepoint.

Solicited general symptoms assessed include fatigue, fever, gastrointestinal symptoms and headache. 4 subjects received additional vaccination at Month 186 and 1 subject at Month 198.

Time frame: During the 4-day (Days 0-3) follow-up period after additional vaccination

Population: Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (\< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

Solicited local symptoms assessed include pain, redness and swelling. Additional vaccination was given to 4 subjects at the Month 186 timepoint and to 1 subject at the Month 198 timepoint.

Time frame: During the 4-day (Days 0-3) follow-up period after additional vaccination

Population: Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (\< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.

An AE 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. 4 subjects received additional vaccination at Month 186 and 1 at Month 198.

Time frame: During the 30-day follow-up period after additional vaccination

Population: Analysis was performed on the Long Term Total cohort, only on subjects who received an additional vaccine dose during the current long-term follow-up study. If a subject became seronegative (\< 15 mIU/mL) at any of the long-term blood sampling timepoint, he/she was offered an additional vaccine dose.