Long-term follow-up at Month 198: 21 October 2008 to 07 December Long-term follow-up at Month 186: 01 October 2007 to 19 December 2008

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1 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country. Study No.: (HAV-235 Ext. 112 Month 138) / (HAV-236 Ext. 112 Month 150) / (HAV-237 Ext. 112 Month 162) / (HAV-238 Ext. 112 Month 174) / (HAV-239 Ext. 112 Month 186) / (HAV-112 Ext. Month 198) / (HAV-112 Ext. Month 210) Title: Double-blind randomized study to evaluate the immunogenicity and reactogenicity of two different lots of GlaxoSmithKline Biologicals inactivated hepatitis A vaccine containing 1440 EL.U. of antigen per ml and injected according to a 0, 12 month schedule in healthy adult volunteers. Rationale: The aim of the study was to evaluate the long-term persistence of humoral immune response of GlaxoSmithKline (GSK) Biologicals Havrix up to 20 years after a 2-dose primary vaccination. The safety and immunogenicity of the study vaccine was also assessed in subjects who, after being identified as seronegative for anti-hepatitis A virus (HAV) antibodies, received an additional vaccine dose of Havrix. Havrix TM (HAV): GSK Biologicals inactivated HAV vaccine. This CTRS presents the data up to Month 210. This document will be updated when additional data become available. Phase: III Study Period: Long-term follow-up at Month 138: 03 January 2004 to 15 March 2004 Long-term follow-up at Month 150: 25 October 2004 to 01 December 2004 Long-term follow-up at Month 162: 24 October 2005 to 09 December 2005 Long-term follow-up at Month 174: 10 October 2006 to 07 December 2006 Long-term follow-up at Month 186: 01 October 2007 to 19 December 2008 Long-term follow-up at Month 198: 21 October 2008 to 07 December 2009 Long-term follow-up at Month 210: 02 November 2009 to 08 December 2009 Study Design: The primary study was a double-blind, randomized study with 2 parallel groups. The follow-up phase of the study was open and self-contained. Centers: Single center study in Belgium. Indication: Immunization against hepatitis A of healthy adults aged between 18 and 40 years at the time of first vaccination. Treatment: In the primary study, the subjects received two doses of either of the two HAV vaccine lots. For the data analyses in the long-term follow-up (LTFU), the 2 groups were pooled. If a subject became seronegative for anti-hav antibodies (i.e. titers < 15 miu/ml) at any of the long-term blood sampling time points (i.e. Months 138, 150, 162, 174 or 186), he/ she was offered an additional vaccine dose (administered between 6 to 12 months after Month 186 time point). From Month 198 onwards, if a subject became seronegative for anti-hav antibodies, he/she was offered an additional vaccine dose (to be administered within 12 months from the time point). This was done in order to assess the immune memory after a primary two-dose schedule of HAV vaccine. HAV vaccine was administered intramuscularly into the deltoid region at a dose level of 1440 EL.U per ml. Objectives: To evaluate the long-term persistence of anti-hav antibodies at Months 138, 150, 162, 174, 186, 198 and 210, after the first vaccine dose of the two-dose primary vaccination. To evaluate the immune memory (after a primary two-dose schedule of HAV vaccine) in subjects with anti-hav antibodies concentrations < 15 miu/ml during any of the long-term blood sampling time points (i.e. Months 138, 150, 162, 174, 186, 198 and 210) and who received the additional vaccine dose. Primary Outcome/Efficacy Variable: Seropositivity rates and geometric mean antibody concentrations (GMCs) (calculated on seropositive subjects) for anti-hav antibodies at Months 138, 150, 162, 174, 186, 198 and 210. Secondary Outcome/Efficacy Variable(s): Occurrence of Serious adverse events (SAEs) determined by the investigator to have a causal relationship to vaccination or to study procedures or lack of vaccine efficacy at Months 138, 150, 162, 174, 186, 198 and 210. In the subjects receiving an additional vaccine dose*: Anti-HAV antibody concentrations before, 14 days and 30 days after the additional vaccination.

2 Occurrence of solicited local and general symptoms during the 4-day follow-up period after vaccination. Occurrence, intensity and causal relationship of unsolicited symptoms during the 30-day follow-up period after vaccination. Occurrence of SAEs during the follow-up period after additional vaccination. *None of the subjects received additional vaccination at the Month 210 time point *Data for the subsequent time points (Month 222 to Month 246) will be reported when available. Statistical Methods: The analyses were performed on the Long-Term (LT) Total Cohort and the LT According-to-Protocol (ATP) cohort for immunogenicity. The LT Total Cohort included all subjects who returned for the follow-up and who belonged to the Total Cohort in the primary study. The LT-ATP cohort for immunogenicity included those subjects who returned for the follow-up and who were included in the ATP cohort for immunogenicity of the primary study, who were not eliminated during the LTFU, who did not receive an extra study vaccine administration (or vaccine with equivalent antigen component) since the previous LTFU visit, who did not show abnormal increase in antibody concentrations since the previous LTFU visit, who did not report incidence of hepatitis A disease and who came back for LTFU blood samples within the acceptable time interval. The definition of abnormal increase depended on the magnitude of the antibody concentration at the previous time point (reference value). Abnormal increase in antibody concentrations was defined as a two-fold increase or more in antibody (when the antibody concentration at the reference time point was 100 miu/ml) or a four-fold increase or more (when the antibody concentration at the reference time point was < 100 miu/ml). Analysis of immunogenicity: The analysis of immunogenicity was performed on the LT-ATP cohort for immunogenicity. The seropositivity rates and GMCs (calculated on seropositive subjects) with 95% confidence intervals (CI) for anti- HAV antibodies were tabulated for pooled groups. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. A seronegative subject was defined as a subject with anti-hav antibody concentration < 15 miu/ml. A seropositive subject was defined as a subject with anti-hav antibody concentration 15 miu/ml. In the subjects receiving an additional vaccine dose, anti-hav antibody concentrations before, 14 days and 30 days after the additional vaccination were tabulated per subject. Analysis of safety : The analysis was performed on the LT Total Cohort. The occurrence of SAEs from the end of the primary study till Month 210 of the LTFU was tabulated according to medical dictionary for regulatory activities (MedDRA) preferred terms. Only SAEs that were assessed by the investigator as causally related to primary vaccination or to the study procedure were tabulated; lack of vaccine efficacy was also to be reported as an SAE. In the subjects receiving an additional vaccine dose: The incidence of solicited local and general symptoms occurring during the 4 days after vaccination was tabulated with exact 95% CI. The same calculation was performed for symptoms of any intensity, those with intensity of grade 3, as well as for solicited general symptoms with relationship to vaccination. The percentage of subjects with at least one report of an unsolicited adverse event classified by MedDRA Preferred Term during the 30-day follow-up period after vaccination. The same tabulation was performed for grade 3 unsolicited adverse events and for unsolicited adverse events that were assessed by the investigator as causally related to vaccination. SAEs during the follow-up period after additional vaccination were also tabulated. Any event related to lack of vaccine efficacy (i.e. hepatitis A infection) up to the Month 210 time point was to be described in detail. Study Population: Healthy adults between 18 and 40 years of age at the time of first vaccination. Written informed consent was obtained from each subject before each blood sampling visit in this LTFU study. Month 138 time point Entered, N (LT Total 107 Completed, n (%) 107 (100)

3 N (LT Total 107 Females: Males 77:30 Mean Age, years (SD) 42.2 (5.44) White/Caucasian, n (%) 107 (100) Month 150 time point Entered, N (LT Total 117 Completed, n (%) 117 (100) N (LT Total 117 Females: Males 87:30 Mean Age, years (SD) 42.9 (5.35) White/Caucasian, n (%) 127 (100) Month 162 time point Entered, N (LT Total 127 Completed, n (%) 127 (100) N (LT Total 127 Females: Males 93:34 Mean Age, years (SD) 43.4 (5.34) White/Caucasian, n (%) 127 (100) Month 174 time point Entered, N (LT Total 127 Completed, n (%) 127 (100) N (LT Total 127 Females: Males 94:33 Mean Age, years (SD) 44.5 (5.37) White/Caucasian, n (%) 127 (100) Month 186 time point Entered, N (LT Total 129 Completed, n (%) 129 (100) N (LT Total 129 Females: Males 98:31 Mean Age, years (SD) 45.4 (5.39) White/Caucasian, n (%) 129 (100) Month 198 time point 135 Randomized, N (LT Total Completed, n (%) 135 (100)

4 N (LT Total 135 Females: Males 103:32 Mean Age, years (SD) 46.3 (5.35) White/Caucasian, n (%) 135 (100) Month 210 time point 124 Randomized, N (LT Total Completed, n (%) 124 (100) N (LT Total 124 Females: Males 93:31 Mean Age, years (SD) 47.6 (5.39) White/Caucasian, n (%) 124 (100) Primary Efficacy Results: Seropositivity rates and GMCs (calculated on seropositive subjects) for anti-hav antibody concentrations, for the (LT-ATP cohort for immunogenicity) Timing N S+ GMC (miu/ml) n % 95% CI Value 95% CI LL UL LL UL PI(D15) PI(M1) PI(M2) PI(M3) PI(M4) PI(M5) PI(M6) PI(M7) PI(M8) PI(M9) PI(M10) PI(M11) PI(M12) PII(M13) PII(M24) PII(M36) PII(M48) PII(M60) PII(M78) PII(M90) PII(M102) PII(M114) PII(M126) PII(M138) PII(M138)* PII(M150) PII(M162) PII(M174) PII(M186) PII(M198) PII(M210) * The lab assay was changed at Month 138, thus the blood samples were re-tested with the old assay for the sake of bridging.

5 N = number of subjects with available results n (%) = number (percentage) of subjects with anti-hav antibody titers 20 miu/ml for time points PI(D15) to PII(M138) n (%) = number (percentage) of subjects with anti-hav antibody titers 15 miu/ml for time points PII(M138)* to PII(M 210) S+ = Seropositivity for anti-hav antibodies defined as - antibody concentrations 20 miu/ml for time points PI (D15) to PII(M138) antibodies defined as antibody concentrations 15 miu/ml for time points PII(M138)* to PII(M 210) 95% CI = 95% confidence interval; LL = Lower Limit, UL = Upper Limit GMC = geometric mean antibody concentration calculated on seropositive subjects Px(Month y) = Blood sampling after Dose X; y months after the first dose of the primary vaccination All the subject who received additional vaccination from Month 186 onwards were considered as seronegative for LT-ATP immunogenicity analysis Secondary Outcome variable(s): Anti-HAV antibody concentrations before, 14 days and 30 days after the additional vaccination for subjects who received additional vaccine dose (LT Total. Additional Vaccination at Month 186 time point Anti-HAV (miu/ml) before additional vaccination* Anti-HAV (miu/ml) at Day 14 postadditional vaccination < < *4 subjects received additional vaccine dose after Month 186. Additional Vaccination at Month 198 time point Anti-HAV (miu/ml) at Day 30 post-additional vaccination Anti-HAV (miu/ml) before additional vaccination* Anti-HAV (miu/ml) at Day 14 postadditional vaccination Anti-HAV (miu/ml) at Day 30 post-additional vaccination *1 subject received additional vaccine dose after Month 198 Secondary Outcome variable(s): Number (percentage) of subjects who received additional vaccine dose after Month 186 and reported solicited local symptoms reported during the 4-day (Days 0-3) post-vaccination period (LT Total. Symptom Intensity N n % 95 % CI LL UL Pain Any Grade Redness (mm) Any > Swelling (mm) Any > N = with the administered dose n (%) = Number (percentage) of subjects reporting at least once the symptom 95%CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of a local symptom regardless of intensity grade Grade 3 pain = Pain that prevented normal everyday activities Secondary Outcome variable(s): Number (percentage) of subjects who received additional vaccine dose after Month 198 and reported solicited local symptoms reported during the 4-day (Days 0-3) post-vaccination period (LT Total. Symptom Intensity N n % 95% CI LL UL Pain Any Grade Redness (mm) Any >

6 Swelling (mm) Any > N = with the administered dose n (%) = Number (percentage) of subjects reporting at least once the symptom 95%CI (not calculated as N = 1) = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of a local symptom regardless of intensity grade Grade 3 pain = Pain that prevented normal everyday activities. Secondary Outcome variable(s): Number (percentage) of subjects who received additional vaccine dose after Month 186 and reported solicited general symptoms reported during the 4-day (Days 0-3) post-vaccination period (LT Total. Symptom Intensity/Relationship N n % 95% CI LL UL Fatigue Any Grade Related Fever (Axillary) ( C) 37.5 C > 39.1 C Related Gastrointestinal Any Grade Related Headache Any Grade Related N = with the administered dose n (%) = Number (percentage) of subjects reporting at least once the symptom 95%CI = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of a general symptom irrespective of intensity grade or relationship to vaccinations Grade 3 = Symptom which prevented normal everyday activities Related = Symptom assessed by the investigator as causally related to study vaccination Secondary Outcome variable(s): Number (percentage) of subjects who received additional vaccine dose after Month 198 and reported solicited general symptoms reported during the 4-day (Days 0-3) post-vaccination period (LT Total. Symptom Intensity/Relationship N n % 95% CI LL UL Fatigue Any Grade Related Fever (Axillary) ( C) 37.5 C > 39.1 C Related Gastrointestinal Any Grade Related Headache Any Grade Related N = with the administered dose n (%) = Number (percentage) of subjects reporting at least once the symptom 95%CI (not calculated as N = 1) = Exact 95% confidence interval; LL = lower limit, UL = upper limit Any = Incidence of a general symptom irrespective of intensity grade or relationship to vaccinations Grade 3 = Symptom which prevented normal everyday activities Related = Symptom assessed by the investigator as causally related to study vaccination

7 Safety results: Number (%) of subjects who received an additional vaccine dose after Month 186, with unsolicited adverse events (LT Total. Most frequent adverse events occurring during the 30-day follow-up vaccination period after vaccination N=4 Subjects with any AE(s), n (%) 0 (0.0) Safety results: Number (%) of subjects who received an additional vaccine dose after Month 198, with unsolicited adverse events (LT Total. Most frequent adverse events occurring during the 30-day follow-up vaccination period after vaccination N=1 Subjects with any AE(s), n (%) 0 (0.0) vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported at Month 138 (LT Total N=107 N=107 vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported at Month 150 (LT Total N=117 N=117 vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported at Month 162 (LT Total N=127 N=127 Safety Results: Number (%) of subjects with SAEs assessed by the investigator related to the primary vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported between Month 174 (LT Total N=127 N=127 vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported at Month 186 (LT Total

8 N=129 N=129 Safety Results: Number (%) of subjects with SAEs occurring during the 30-day follow-up period after the additional vaccination period (LT Total N=4 N=4 vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported at Month 198 (LT Total N=135 N=135 Safety Results: Number (%) of subjects with SAEs occurring during the 30-day follow-up period after the additional vaccination period (LT Total N=1 N=1 vaccination, to the procedures during the LT follow-up, or lack of vaccine efficacy, reported at Month 210 (LT Total N=124 N=124 Conclusion: At Month 138, 150, 162, 174, 186 and 198, 95.6%, 96.8%, 97.0%, 98.0%, 96.9% and 96.0% of the subjects had anti-hav antibody concentrations 15 miu/ml with a GMC value of 378.6, 419.3, 342.2, 318.9, and miu/ml respectively. No unsolicited adverse events or SAEs occurred during these follow-ups. At Month 210, 96.7% of the subjects had anti-hav antibody concentrations 15 miu/ml with a GMC value of miu/ml. No additional vaccine was administered at Month 210 and there were no SAEs reported since the previous long-term follow-up visit to Month 210. Publications: None. Date updated: 05-November-2010

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