GSK Medicine: Study No.: Title: Rationale: Objectives: Indication: Study Investigators/Centers: Research Methods: Data Source:

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1 GSK Medicine: Not applicable Study No.: (EPI-HAV-003 BOD MX) Title: Sero-prevalence of Hepatitis A, Varicella-Zoster virus, Cytomegalovirus, Herpes Simplex and Bordetella pertussis in Mexico. Rationale: The aim of this study was to document the epidemiological changes in the sero-prevalence of Hepatitis A Virus (HAV), Herpes Simplex Virus Types 1 and 2 (HSV-1 and -2), Varicella Zoster Virus (VZV), Cytomegalovirus (CMV) and Bordetella pertussis (BP) infections in Mexico, using the National Health and Nutrition Survey (ENSANUT 2006). Objectives: Primary objective To determine sero-prevalence of HAV, CMV, VZV, HSV and BP infections in Mexico. Secondary objectives To determine the sero-prevalence of HAV, CMV, VZV, HSV and BP according to socioeconomic status (SES), age group, gender, region and risk group (including but not only: medical history, sexual behaviours, education, pregnancy history). To evaluate pertussis vaccination history on BP antibody levels among different age groups. To identify asymptomatic carriers of BP across Mexican population. Indication: Prevalence of HAV, CMV, VZV, HSV and BP infections in Mexico in subjects aged 1 to 70 years Study Investigators/Centers: GSK conducted study - 1 center in Mexico. Research Methods: Data Source: Data and serum samples collected through the ENSANUT Study Design: Cross-sectional study Study Population: Random sample of subjects aged 1 to 70 years who participated in the 2006 ENSANUT, with previously obtained informed consent. Study Exposures, Outcomes: This summary presents results for all subjects included in this study (random sample of subjects who participated in the 2006 ENSANUT). Primary outcomes Anti-HAV seropositivity status. - Subjects with anti-hav antibody titers assay cut-off. Anti-Pertussis Toxin seropositivity status for Immunoglobulin G (IgG) and Immunoglobulin A (IgA)*. - Subjects with anti-pertussis Toxin antibody titers assay cut-off for IgG. - Subjects with anti-pertussis Toxin antibody titers assay cut-off for IgA*. Anti-VZV seropositivity status. - Subjects with anti-vzv antibody titers assay cut-off. Anti-CMV seropositivity status. - Subjects with anti-cmv antibody titers assay cut-off. Anti-HSV seropositivity status (defined as the percentage of subjects with anti-hsv 1 and 2 titers assay cut-off). - Subjects with anti-hsv antibody titers assay cut-off. Secondary outcomes Difference in HAV, CMV, VZV, HSV and BP seropositivity rates according to the following parameters: - Area - Region - - Gender - Socioeconomic stratum - Risk groups (including but not only: medical history, sexual behaviours, education, pregnancy history) - Pertussis vaccination status* *Anti-Pertussis Toxin IgA were not assessed. *Data only available for children (1-9 years) Data Analysis Methods: The analyses were performed on the According-To-Protocol (ATP) Cohort. - The ATP Cohort included all evaluable subjects (i.e., those meeting all eligibility criteria, complying with the procedures defined in the protocol). 1

2 The number of subjects seropositive for anti-hav, anti-vzv, anti-cmv, antihsv-1, anti-hsv-2 and anti-bp was tabulated for all the subjects. Chi-square test (or Fisher's exact test depending on the case) was performed to compare the difference in every single disease (HAV, BP, VZV, CMV and HSV) of seroprevalence between the areas, genders, age-strata, regions and socioeconomic groups separately. Descriptive statistics were provided for risk factor in every single disease. The percentage of subjects who were seropositive for anti-bp antibodies was also stratified by pertussis vaccination status, in children (1-9 years). Limitations: Not applicable Study Results: Demographics/Baseline Characteristics Study Group Planned, N 4000 N (ATP Cohort) 3658 Mean, years (SE) 29.0 (0.6) Females:Males 1968:1686 Primary Outcome Measure: Percentage of subjects seropositive for anti-hav, anti-vzv, anti-cmv, anti-hsv antibodies and anti-bp antibodies (ATP Cohort) Antibodies n Seropositive 95% CI N % LL UL Anti-HAV Anti-VZV Anti-CMV Anti-HSV Anti-HSV Anti-BP IgG %CI = exact 95% two-sided confidence interval LL = lower limit UL= upper limit Seropositivity was defined as below: Anti-HAV: - < 1.00 = nonreactive - > 1.00 = reactive Anti-VZV: - < 0.1 = negative - > 0.2 = positive Anti-CMV: - < 6 = nonreactive - > 6 = reactive Anti-HSV 1 & anti-hsv 2 (qualitative results): - IgG positive - IgG negative Anti-BP IgG: - < 11 = negative - > 11 = positive Secondary Outcome Measure: Difference in HAV, VZV, CMV, HSV, BP sero-prevalence between areas (ATP Cohort) N Rural Urban P-value n N % N N % Anti-HAV Anti-VZV <.0001 Anti-CMV Anti-HSV Anti-HSV Anti-BP IgG

3 Secondary Outcome Measure: Difference in HAV, VZV, CMV, HSV, BP sero-prevalence between regions (ATP Cohort) N Center District Federal North South P- value n N % n N % n N % n N % Anti-HAV Anti-VZV Anti-CMV Anti-HSV Anti-HSV Anti-BP IgG Secondary Outcome Measure: Difference in HAV, VZV, CMV, HSV and BP sero-prevalence between age strata (ATP Cohort) N Children (1-9) Adolescent (10-19) Adult ( 20) P- value n N % n N % n N % Anti-HAV <.0001 Anti-VZV <.0001 Anti-CMV <.0001 Anti-HSV <.0001 Anti-HSV <.0001 Anti-BP IgG Secondary Outcome Measure: Difference in HAV, VZV, CMV, HSV, BP sero-prevalence between genders (ATP Cohort) N Female Male P-value n N % n N % Anti-HAV Anti-VZV Anti-CMV Anti-HSV Anti-HSV Anti-BP IgG Secondary Outcome Measure: Difference in HAV, VZV, CMV, HSV, BP sero-prevalence between SES (ATP Cohort) N Low Medium High P-value n N % n N % n N % Anti-HAV Anti-VZV <.0001 Anti-CMV Anti-HSV

4 Anti-HSV Anti-BP IgG Secondary Outcome Measure: Risk factors for anti-hav seropositive subjects (ATP Cohort) N= Characteristics Parameters or n N % 95% CI Chi- P-value Unad 95% CI LL UL Square. OR LL UL Children (1-9 years) Vs Adult ( 20 years) < Adolescent (10-19 years) Gender Female Vs Male Area Urban Vs Rural Region Center District Federal North South SES Low Vs High Medium Vs High Chronic disease status Diabetes present Vs (for adults) Have you ever smoked/ consumed tobacco * Yes Vs No Yes Vs No UL= Upper Limit Secondary Outcome Measure: Risk factors for anti-vzv seropositive subjects (ATP Cohort) N= Characteristics Parameters or n N % 95% CI Chi- P- Unad. 95% CI LL UL Square value OR LL UL Children (1-9 years) < Adolescent ( years) Vs Adult ( 20 years) Gender Female Vs Male Area Urban Vs Rural < Region Center District Federal North South

5 SES Low Vs High < Medium Vs High Chronic disease status (in adults) Diabetes present Vs <.0001 > > > Have you ever Yes Vs No smoked/consumed tobacco * Yes Vs No UL= Upper Limit Secondary Outcome Measure: Risk factors for anti-cmv seropositive subjects (ATP Cohort) N= Characteristics Parameters or n N % 95% CI Chi- P- Unad. 95% CI LL UL Square value OR LL UL Children (1-9 years) < Adolescent ( years) Vs Adult ( 20 years) Gender Female Vs Male Area Urban Vs Rural Region Center District Federal North South SES Low Vs High Chronic disease status (in adults) Have you ever smoked/consumed tobacco * Medium Vs High Diabetes present Vs <.0001 > > > Yes Vs No Yes Vs No

6 UL= Upper Limit Secondary Outcome Measure: Risk factors for anti-hsv type 1 seropositive subjects (ATP Cohort) N= Characteristics Parameters or n N % 95% CI Chi- P-value Unad. 95% CI LL UL Square OR LL UL Children (1-9 years) Vs Adult ( 20 years) Adolescent (10-19 years) Vs Adult ( 20 years) < Gender Female Vs Male Area Urban Vs Rural Region Center District Federal North South SES Low Vs High Medium Vs High Chronic disease status (in adults) Diabetes present Vs Have you ever smoked/consum ed tobacco * Yes Vs No Yes Vs No UL= Upper Limit Secondary Outcome Measure: Risk factors for anti-hsv type 2 seropositive subjects (ATP Cohort) N= Characteristics Parameters or n N % 95% CI Chi- P-value Unad. 95% CI LL UL Square OR LL UL Children (1-9 years) Vs Adult ( 20 years) Adolescent (10-19 years) Gender Female Vs Male Area Urban Vs Rural Region Center District Federal North South

7 SES Low Vs High Medium Vs High Chronic disease Diabetes present Vs status (in adults) Have you ever Yes Vs No smoked/consumed tobacco * Yes Vs No UL= Upper Limit Secondary Outcome Measure: Risk factors for BP IgG seropositive subjects (ATP Cohort) N= Characteristics Parameters or n N % 95% CI Chi- P- Unad. 95% CI LL UL Square value OR LL UL Children (1-9 years) Vs < Adult ( 20 years) Adolescent (10-19 years) Gender Female Vs Male Area Urban Vs Rural Region Center District Federal North South SES Low Vs High Medium Vs High Chronic disease Diabetes present Vs status (in adults) Have you ever smoked/consum ed tobacco * Yes Vs No Yes Vs No

8 UL= Upper Limit Secondary Outcome Measure: Percentage of subjects who are seropositive for anti-bp antibodies stratified by pertussis vaccination status, in children (1-9 years) (ATP Cohort) Antibodies Pertussis vaccination status Seropositive 95% CI n N % LL UL Anti-BP IgG Vaccinated Not vaccinated %CI = exact 95% two-sided confidence interval LL = lower limit UL= upper limit Conclusion: The sero-prevalence of HAV, CMV, VZV, HSV-1, HSV-2 and BP infections in Mexico was 84.2%, 89.2%, 85.8%, 80.9%, 9.9% and 47.4%, respectively. Publications: Lazcano-Ponce E et al. Seroprevalence of bordetella pertussis antibodies in Mexican Population: A cross-sectional study. Abstract presented at the 51st Annual Interscience Conference on Antimicrobial nts & Chemotherapy (ICAAC). Berlin, Germany, September Effelterre TV et al. Model-based projections of the population-level impact of Hepatitis A vaccination in Mexico. Abstract presented at the Excellence In Paediatrics (EIP). Istanbul, Turkey, 30 November-3 December Date updated: 10-April