Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives Primary Outcome/Efficacy Variable:

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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.: /009 (HPV-009) Title: A double blind, controlled, randomized, phase III study of the efficacy of an HPV16/18 VLP vaccine in the prevention of advanced cervical intraepithelial neoplasia (CIN2, CIN3, adenocarcinoma in situ [AIS] and invasive cervical cancer) associated with HPV16 or HPV18 cervical infection in healthy young adult women in Costa Rica. HPV16/18 VLP (HPV): GlaxoSmithKline (GSK) Biologicals Human Papilloma Virus 16 and 18 virus-like particle based candidate vaccine. Rationale: The aim of this study was to evaluate the prophylactic efficacy of HPV vaccine against the development of incident, histopathologically confirmed cervical intraepithelial neoplasia (CIN) associated with HPV16 or HPV18 cervical infections, using the licensed GSK hepatitis A vaccine as an active control. Havrix (HAV): GSK Biologicals Hepatitis A inactivated virus vaccine. Phase: III Study Period: From 28 June 2004 to 17 December 2010 Study Design: A double blind, self-contained, active-control, randomised (1:1), single-centre study, with 2 parallel groups. Centres: 1 centre in Costa Rica Indication: Primary immunisation of healthy women between years of age against HPV16 or HPV18 cervical infection. Treatment: The treatment groups were as follows. HPV Group: Subjects received 3 doses of HPV vaccine at study Months 0, 1 and 6. Control Group: Subjects received 3 doses of HAV vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm. Objectives: To demonstrate the efficacy of the candidate vaccine compared with control in the prevention of histopathologically confirmed CIN2+* associated with an HPV16 or HPV18 cervical infection post Dose 3 (from Month 6 to Month 48), in young adult women negative for HPV deoxyribonucleic acid (DNA) by polymerase chain reaction (PCR) at Months 0 and 6 for the corresponding HPV type. *CIN2+ is defined as CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer Primary Outcome/Efficacy Variable: Histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection detected by PCR in the preceding cervical cytology specimen in previously negative subjects for HPV DNA by PCR at Months 0 and 6 for the corresponding HPV type. Note: Preceding cervical cytology was defined as the last cervical cytology specimen collected before the histopathology specimen was obtained. Secondary Outcome/Efficacy Variable(s): Efficacy Time to occurrence of incident cervical infection with HPV16 or HPV18 detected by PCR. Histopathologically confirmed CIN2+ cases associated with infection by any oncogenic HPV type (including HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), detected by PCR in the preceding cervical cytology specimen in previously negative subjects for HPV DNA (by PCR) at Months 0 and 6 for the corresponding HPV type. Histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection detected by PCR within the lesional component of the cervical tissue specimen in previously negative subjects for HPV DNA (by PCR) at Months 0 and 6 and seronegative by ELISA at Month 0 for the corresponding HPV type. Persistent HPV16 or HPV18 cervical infection cases, defined as detection of the same HPV type (by PCR) in cervical samples from all consecutive evaluations over approximately 12 months from Month 6 to Month 48. Immunogenicity HPV16 and HPV18 ELISA and V5/J4 monoclonal antibody inhibition Enzyme Immunoassay (EIA) titres in the 600 subjects enrolled into the immunogenicity subcohort. Safety Occurrence and intensity of solicited local adverse events (AEs) and occurrence (either onset or aggravation) of solicited general AEs including urticaria within 60 minutes after each vaccination and over all vaccinations

2 combined. Occurrence and intensity of solicited local AEs and solicited general AEs on a 10% random subset of participants on one day from Day 3 to Day 6 after each vaccination and over all vaccinations combined. Occurrence of unsolicited AEs and SAEs throughout the entire study (Month 0 up to Month 48). Outcome of all pregnancies. HPV 66 type was not assessed because it is classified only as possibly oncogenic according to World Health Organization - International Agency for Research on Cancer (WHO-IARC) criteria. This analysis was not performed, in accordance with the Statistical Analysis Plan submitted to the FDA. Statistical Methods: The analyses were performed on the Total Vaccinated cohort (for safety), the According-To-Protocol (ATP) cohort for efficacy and the ATP cohort for immunogenicity. The Total Vaccinated cohort included all vaccinated subjects with at least 1 vaccine administration documented. The ATP cohort for efficacy included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) for whom efficacy data were available, who received 3 doses of vaccine, who were HPV DNA (by PCR) negative for the corresponding type at enrollment and at the time when the third dose was administered (Month 6 visit) and who did not have a biopsy or treatment during the vaccination phase (i.e., prior to the Month 6 visit). The ATP cohort for immunogenicity included all evaluable subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol, with no elimination criteria during the study) who received 3 doses of vaccine, who were HPV DNA (by PCR) negative for the corresponding type at enrollment and during the 48-month follow-up period, who did not have a biopsy or treatment during the vaccination phase (i.e., prior to the Month 6 visit) and for whom immunogenicity results were available. An immunogenicity subcohort was defined with a subset of 557 subjects from the 2 groups of this ATP cohort: subjects attended one extra clinic visit approximately one month (30 to 60 days) after the last dose was administered (Month 7 visit). Analysis of efficacy The analysis was carried out on the ATP cohort for efficacy. Vaccine efficacy (VE) was calculated in comparing the candidate vaccine with the control vaccine in the prevention of histopathologically confirmed CIN2+* associated with an HPV16 or HPV18 cervical infection post Dose 3 (from Month 6 to Month 48), in subjects negative for HPV DNA by PCR at Months 0 and 6 for the corresponding HPV type. VE and the 95% confidence intervals (CIs) were estimated using the conditional exact method. VE was defined as 1 minus the ratio of the attack rates in the HPV and control cohorts. The attack rate was the percentage of women in the cohort who developed the event. The incidence rates of cervical infection were compared between the 2 groups using an extension of the exact conditional test (based on a sum of binomial random variables). The time to occurrence of incident cervical infection with HPV16 or HPV18 detected by PCR was tabulated by group during the entire study period. The number of histopathologically confirmed CIN2+ cases associated with HPV16 or HPV18 infection, in previously HPV16/18 DNA negative subjects at Months 0 and 6 for the corresponding HPV type, was tabulated by group for the period post dose 3 (from Month 6 to Month 48). The same analysis was carried out for the number of histopathologically confirmed CIN2+ cases associated with any oncogenic HPV type infection in previously HPV DNA negative subjects. The number of persistent HPV16 or HPV18 cervical infection cases, i.e. defined as detection of the same HPV type (by PCR) in cervical samples from all consecutive evaluations over approximately 12 months, was tabulated from Month 6 to Month 48. Analysis of immunogenicity: The analyses were performed on the ATP cohort for immunogenicity. For each treatment group, at each time point that a blood sample result was available, seropositivity rates for HPV-16 and HPV-18 with exact 95% CI as well as geometric mean titers (GMTs) with 95% CI were tabulated based on ELISA quantification results. The same tabulation was made based on V5/J4 monoclonal antibodies inhibition results. For anti-hpv-16 antibody, seropositivity (ELISA) was defined as antibody titer 8 EL.U/mL and for anti-hpv-18 antibody, as antibody titer 7 EL.U/mL. For anti-hpv-16 antibody (V5), seropositivity was defined as antibody titer 41 EL.U/mL and for anti-hpv-18 antibody (J4), as antibody titer 110 EL.U/mL. Safety The analysis of safety was based on the Total Vaccinated cohort. The incidence of solicited local and general symptoms occurring 60 minutes after each vaccination was tabulated with exact 95%CI for each treatment group. The same tabulation was performed for symptoms with intensity of Grade 3. The

3 occurrence and intensity of solicited local and general symptoms reported during a 4-day post-vaccination period (from Day 3 to Day 6) was also tabulated with exact 95%CI for each treatment group in a 10% random subset of participants. The percentage of subjects with at least one report of an unsolicited adverse event classified by the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term, within 30 days (Days 0-29) after vaccination, was tabulated for each treatment group. The same tabulation was performed for unsolicited AEs reported during the entire study period. SAEs were collected and summarized through the entire study period, from Month 0 up to Month 48. Occurrence of pregnancies and their outcome were reported during the entire study period. Study Population: Healthy women between and including years of age at the time of first study vaccination, who were seronegative for HPV, with neither history of vaccination against nor infection by Hepatitis A, and who planned to reside in the Guanacaste province and surroundings for the six months following first vaccine dose. Written informed consent was obtained from the subject prior to enrolment. Number of Subjects HPV Group Control Group Planned*, N Randomised, N (Total Vaccinated Cohort) Completed, n (%) 3453 (92.6) 3481 (93.1) Total Number Subjects Withdrawn, n (%) 274 (7.4) 258 (6.9) Withdrawn due to Adverse Events n (%) 14 (0.4) 11 (0.3) Withdrawn due to Lack of Efficacy n (%) Not applicable Not applicable Withdrawn for other reasons n (%) 260 (7.0) 247 (6.6) Demographics HPV Group Control Group N (Total Vaccinated Cohort) Females: Males 3727:0 3739:0 Mean Age, years (SD) 21.1 (2.3) 21.1 (2.3) Race, n (%) Not available Not available * Maximum approved by Institutional Review Board Primary Efficacy Results: Incidence rates and vaccine efficacy against histopathologically confirmed CIN2+ associated with HPV-16 and/or HPV-18 cervical infection using conditional exact method (ATP cohort for efficacy) Rate per 1000 VE women Event Type Group N Number n LL UL % LL UL P-value Events HPV Control HPV16 and/or 18 Associated CIN2+ HPV16 Associated CIN2+ HPV Control HPV18 Associated CIN2+ HPV Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against cervical infection associated with HPV-16 and/or HPV-18 during the entire study period using conditional exact method (ATP cohort for efficacy) Rate per 1000 women VE n LL UL % LL UL Event Type Group N Number Events HPV16 and/or 18 Cervical HPV Infection Control HPV16 Cervical Infection HPV Control HPV18 Cervical Infection HPV

4 Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against cervical infection associated with HPV-16 and/or HPV-18 during the first year of follow-up period using conditional exact method (ATP cohort for efficacy) Rate per 1000 women VE Event Type Group N Number n LL UL % LL UL Events HPV16 and/or 18 Cervical Infection HPV Control HPV16 Cervical Infection HPV Control HPV18 Cervical Infection HPV Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against cervical infection associated with HPV-16 and/or HPV-18 during the second year of follow-up period using conditional exact method (ATP cohort for efficacy) Rate per 1000 VE women Event Type Group N Number n LL UL % LL UL Events HPV16 and/or 18 Cervical Infection HPV Control HPV16 Cervical Infection HPV Control HPV18 Cervical Infection HPV Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against cervical infection associated with HPV-16 and/or HPV-18 during the third year of follow-up period using conditional exact method (ATP cohort for efficacy) Rate per 1000 women Event Type Group N Number Events VE n LL UL % LL UL

5 HPV16 and/or 18 Cervical Infection HPV Control HPV16 Cervical Infection HPV Control HPV18 Cervical Infection HPV Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against cervical infection associated with HPV-16 and/or HPV-18 from the fourth year follow-up period using conditional exact method (ATP cohort for efficacy) Rate per 1000 VE women Event Type Group N Number n LL UL % LL UL Events HPV16 and/or 18 Cervical Infection HPV Control HPV16 Cervical Infection HPV Control HPV18 Cervical Infection HPV Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against histopathologically confirmed CIN2+ associated with infection by any oncogenic HPV types, using conditional exact method (ATP cohort for efficacy) Rate per 1000 VE women Event Type Group N Number n LL UL % LL UL Events HPV16 Associated CIN2+ HPV Control HPV18 Associated CIN2+ HPV Control HPV31 Associated CIN2+ HPV Control HPV33 Associated CIN2+ HPV Control HPV35 Associated CIN2+ HPV Control HPV39 Associated CIN2+ HPV Control HPV45 Associated CIN2+ HPV Control HPV51 Associated CIN2+ HPV

6 Control HPV52 Associated CIN2+ HPV Control HPV56 Associated CIN2+ HPV Control HPV58 Associated CIN2+ HPV Control HPV59 Associated CIN2+ HPV Control HPV68 and/or 73* Associated HPV CIN2+ Control Non 16/18 Oncogenic HPV HPV Associated CIN2+ Control Any Oncogenic HPV Associated HPV CIN2+ Control N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95% Lower and Upper confidence limits * The assay did not distinguish between both HPV types Secondary Outcome Variable(s): Incidence rates and vaccine efficacy against persistent infection (12-month definition) associated with HPV types using conditional exact method (ATP cohort for efficacy) Rate per 1000 women Event Type Group N Number n LL UL % LL UL Events Persistent HPV16 and/or 18 Infection HPV Control Persistent HPV16 Infection HPV Control Persistent HPV18 Infection HPV Control Persistent incident HPV-16 and /or HPV-18 cervical infection had to fulfil the following criteria: first detection after the 6-month visit, 2 same type HPV positive (by PCR) test results 10+ months apart, and no intervening HPV negative tests for the corresponding type. N = number of subjects included in each group For single type: Subjects DNA negative at Month 0 and Month 6 for the corresponding HPV type For combined types: Subjects DNA negative at Month 0 and Month 6 for at least one HPV type (subjects are in the analysis of at least one single type) n=number of subjects reporting at least one event in each group Subjects with an event are DNA negative at Month 0 and Month 6 for the corresponding HPV type rate=incidence rate of subjects reporting at least one event VE(%)=Vaccine Efficacy (conditional exact method) LL,UL=95.4% Lower and Upper confidence limits (95.4% limits were used due to alpha adjustment) Secondary Outcome Variable(s): Seropositivity rates (ELISA) and GMTs for anti-hpv-16 antibody in the immunogenicity subcohort (ATP cohort for immunogenicity) 8 EL.U/mL GMT 95% CI 95% CI Group Timing N n % LL UL value LL UL Control PRE PI(M1) VE

7 PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) HPV PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) GMT = geometric mean antibody titer calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval. LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination PI(M1) = Post dose 1 at Month 1 PII(M6) = Post dose 2 at Month 6 PIII(M7) = Post dose 3 at Month 7 PIII(M12) = Post dose 3 at Month 12 PIII(M18) = Post dose 3 at Month 18 PIII(M24) = Post dose 3 at Month 24 PIII(M30) = Post dose 3 at Month 30 PIII(M36) = Post dose 3 at Month 36 PIII(M42) = Post dose 3 at Month 42 PIII(M48) = Post dose 3 at Month 48 Secondary Outcome Variable(s): Seropositivity rates (ELISA) and GMTs for anti-hpv-18 antibody in the immunogenicity subcohort (ATP cohort for immunogenicity) 7 EL.U/mL GMT 95% CI 95% CI Group Timing N n % LL UL value LL UL Control PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) HPV PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18)

8 PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) GMT = geometric mean antibody titre calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval. LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination PI(M1) = Post dose 1 at Month 1 PII(M6) = Post dose 2 at Month 6 PIII(M7) = Post dose 3 at Month 7 PIII(M12) = Post dose 3 at Month 12 PIII(M18) = Post dose 3 at Month 18 PIII(M24) = Post dose 3 at Month 24 PIII(M30) = Post dose 3 at Month 30 PIII(M36) = Post dose 3 at Month 36 PIII(M42) = Post dose 3 at Month 42 PIII(M48) = Post dose 3 at Month 48 Secondary Outcome Variable(s): Seropositivity rates (V5) and GMTs for anti-hpv-16 antibody in the immunogenicity subcohort (ATP cohort for immunogenicity) 41 EL.U/mL GMT 95% CI 95% CI Group Timing N n % LL UL value LL UL Control PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) HPV PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) GMT = geometric mean antibody titre calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval. LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination PI(M1) = Post dose 1 at Month 1 PII(M6) = Post dose 2 at Month 6 PIII(M7) = Post dose 3 at Month 7 PIII(M12) = Post dose 3 at Month 12 PIII(M18) = Post dose 3 at Month 18

9 PIII(M24) = Post dose 3 at Month 24 PIII(M30) = Post dose 3 at Month 30 PIII(M36) = Post dose 3 at Month 36 PIII(M42) = Post dose 3 at Month 42 PIII(M48) = Post dose 3 at Month 48 Secondary Outcome Variable(s): Seropositivity rates (J4) and GMTs for anti-hpv-18 antibody in the immunogenicity subcohort (ATP cohort for immunogenicity) 110 EL.U/mL GMT 95% CI 95% CI Group Timing N n % LL UL value LL UL Control PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) HPV PRE PI(M1) PII(M6) PIII(M7) PIII(M12) PIII(M18) PIII(M24) PIII(M30) PIII(M36) PIII(M42) PIII(M48) GMT = geometric mean antibody titre calculated on all subjects N = number of subjects with available results n/% = number/percentage of subjects with concentration within the specified range 95% CI = 95% confidence interval. LL = Lower Limit, UL = Upper Limit PRE = Pre-vaccination PI(M1) = Post dose 1 at Month 1 PII(M6) = Post dose 2 at Month 6 PIII(M7) = Post dose 3 at Month 7 PIII(M12) = Post dose 3 at Month 12 PIII(M18) = Post dose 3 at Month 18 PIII(M24) = Post dose 3 at Month 24 PIII(M30) = Post dose 3 at Month 30 PIII(M36) = Post dose 3 at Month 36 PIII(M42) = Post dose 3 at Month 42 PIII(M48) = Post dose 3 at Month 48 Secondary Outcome Variable(s): Occurrence of solicited local symptoms reported within 60 minutes after vaccination following each dose and across doses (Total Vaccinated cohort) HPV Group Control Group Sympto m Intensit y 95 % CI 95 % CI N n % LL UL N n % LL UL Dose 1 Pain Any Grade

10 Redness Any > 50 mm Swelling Any > 50 mm Dose 2 Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm Dose 3 Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm Across doses Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm N = number of subjects with at least one administered vaccine dose documented 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 particular symptom regardless of intensity grade Grade 3 pain = pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Secondary Outcome Variable(s): Occurrence of solicited general symptoms reported within 60 minutes after vaccination following each dose and across doses (Total Vaccinated cohort) HPV Group Control Group 95 % CI 95 % CI Symptom Intensity/ N n % LL UL N n % LL UL Relationshi p Dose 1 Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade

11 Fever/(oral) 37.5 C > 39.0 C Dose 2 Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C Dose 3 Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C Across doses Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any

12 Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C N = number of subjects with at least one administered vaccine dose documented 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 particular symptom regardless of intensity grade or relationship to vaccination Grade 3 fatigue, myalgia, arthralgia, gastrointestinal, headache, rash = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 urticaria = occurred on at least 4 body areas. Secondary Outcome Variable(s): Occurrence of solicited local symptoms reported from Day 3 to Day 6 post-vaccination following each dose and across doses, in the subset (Total Vaccinated cohort) HPV Group Control Group 95 % CI 95 % CI Sympto m Intensit y N n % LL UL N n % LL UL Dose 1 Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm Dose 2 Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm Dose 3 Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm Across doses Pain Any Grade Redness Any > 50 mm Swelling Any > 50 mm

13 N = number of subjects with at least one administered vaccine dose documented 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 particular symptom regardless of intensity grade Grade 3 pain = pain that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Secondary Outcome Variable(s): Occurrence of solicited general symptoms reported from Day 3 to Day 6 postvaccination following each dose and across doses, in the subset (Total Vaccinated cohort) HPV Group Control Group 95 % CI 95 % CI Symptom Intensity/ N n % LL UL N n % LL UL Relationshi p Dose 1 Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C Dose 2 Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C Dose 3 Fatigue Any Grade

14 Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C Across doses Fatigue Any Grade Myalgia Any Grade Arthralgia Any Grade Gastrointestina l Any Grade Headache Any Grade Rash Any Grade Urticaria Any Grade Fever/(oral) 37.5 C > 39.0 C N = number of subjects with at least one administered vaccine dose documented 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 particular symptom regardless of intensity grade or relationship to vaccination Grade 3 fatigue, myalgia, arthralgia, gastrointestinal, headache, rash = symptoms that prevented normal everyday activities as assessed by inability to attend work or school and which necessitated the administration of corrective therapy. Grade 3 urticaria = occurred on at least 4 body areas. Secondary Outcome Variable(s): Occurrence of pregnancies and their outcome reported during the entire study period (Total Vaccinated cohort) HPV Group N= 2123 Control Group N= 2129 Outcome n % n % Pregnancy loss Pregnancy resolved alive Unresolved pregnancy N = number of pregnancies n (%) = number (percentage) of cases in a given category. Safety Results: Number (%) of subjects with unsolicited adverse events reported within 30 days after vaccination (Total Vaccinated cohort). Most frequent adverse events -On-Therapy HPV Group Control Group

15 (occurring within Days 0-29 following vaccination) N =3727 N =3739 Subjects with any AE(s), n (%) 1638 (43.9) 1536 (41.1) Influenza 263 (7.1) 293 (7.8) Myalgia 355 (9.5) 166 (4.4) Headache 218 (5.8) 214 (5.7) Pain in extremity 174 (4.7) 80 (2.1) Menstruation irregular 123 (3.3) 112 (3.0) Dizziness 99 (2.7) 84 (2.2) Pyrexia 110 (3.0) 60 (1.6) Malaise 92 (2.5) 76 (2.0) Pruritus 71 (1.9) 76 (2.0) Vomiting 69 (1.9) 67 (1.8) Counting rule applied: As there were more than 30 subjects per treatment group and 3 groups, only the 10 most frequent events in each treatment group are to be listed. Safety Results: Number (%) of subjects with unsolicited adverse events reported during the entire study period (Total Vaccinated cohort). Most frequent adverse events (occurring during entire study period) HPV Group N =3727 Control Group N =3739 Subjects with any AE(s), n (%) 3228 (86.6) 3254 (87.0) Menstruation irregular 1021 (27.4) 1011 (27.0) Influenza 903 (24.2) 950 (25.4) Vaginal infection 709 (19.0) 763 (20.4) Vulvovaginal candidiasis 714 (19.2) 678 (18.1) Urinary tract infection 555 (14.9) 565 (15.1) Upper respiratory tract infection 324 ( 8.7) 327 ( 8.7) Headache 324 ( 8.7) 315 ( 8.4) Myalgia 386 (10.4) 189 ( 5.1) Gastrointestinal inflammation 263 ( 7.1) 249 ( 6.7) Dengue fever 174 ( 4.7) 190 ( 5.1) Counting rule applied: As there were more than 30 subjects per treatment group and 3 groups, only the 10 most frequent events in each treatment group are to be listed. Safety Results: Number (%) of subjects with Serious Adverse Events (SAEs) during the entire study period (from Month 0 up to Month 48) (Total Vaccinated cohort) Serious adverse event, n (%) [n considered by the investigator to be related to study medication] SAEs HPV Group N =3727 Control Group N =3739 Subjects with any SAE(s), n (%) [n assessed by the investigator as related*] 912 (24.5) [53 ] 891 (23.8) [39 ] Abortion spontaneous incomplete 134 ( 3.6) [17] 108 ( 2.9) [7] False labour 66 ( 1.8) [4] 88 ( 2.4) [2] Abortion spontaneous complete 64 ( 1.7) [10] 64 ( 1.7) [13] Abortion missed 59 ( 1.6) [7] 63 ( 1.7) [4] Foetal distress syndrome 57 ( 1.5) [1] 64 ( 1.7) [0] Caesarean section 56 ( 1.5) [0] 59 ( 1.6) [0] Uterine hypotonus 54 ( 1.4) [0] 54 ( 1.4) [0] Gestational hypertension 39 ( 1.0) [0] 53 ( 1.4) [0] Dengue fever 38 ( 1.0) [0] 48 ( 1.3) [0] Abortion threatened 42 ( 1.1) [5] 37 ( 1.0) [0] Cephalo-pelvic disproportion 33 ( 0.9) [0] 45 ( 1.2) [0] Breech presentation 40 ( 1.1) [0] 33 ( 0.9) [0] Urinary tract infection 25 ( 0.7) [0] 24 ( 0.6) [0] Anaemia of pregnancy 24 ( 0.6) [0] 22 ( 0.6) [0] Cholecystitis 26 ( 0.7) [0] 19 ( 0.5) [0] Pre-eclampsia 18 ( 0.5) [0] 23 ( 0.6) [1] Failed induction of labour 19 ( 0.5) [0] 20 ( 0.5) [0] Complication of pregnancy 18 ( 0.5) [0] 19 ( 0.5) [0] Intentional self-injury 20 ( 0.5) [0] 17 ( 0.5) [0]

16 Appendicitis 17 ( 0.5) [0] 18 ( 0.5) [1] Intra-uterine death 16 ( 0.4) [2] 18 ( 0.5) [1] Foetal growth restriction 18 ( 0.5) [0] 14 ( 0.4) [0] Cholelithiasis 22 ( 0.6) [0] 9 ( 0.2) [0] Premature rupture of membranes 11 ( 0.3) [0] 19 ( 0.5) [1] Obstructed labour 13 ( 0.3) [0] 15 ( 0.4) [0] Abnormal product of conception 14 ( 0.4) [0] 11 ( 0.3) [0] Postoperative wound infection 12 ( 0.3) [0] 12 ( 0.3) [0] Ectopic pregnancy 9 ( 0.2) [0] 14 ( 0.4) [0] Postpartum haemorrhage 13 ( 0.3) [0] 7 ( 0.2) [0] Postpartum sepsis 12 ( 0.3) [0] 8 ( 0.2) [0] Oligohydramnios 11 ( 0.3) [0] 8 ( 0.2) [0] Benign ovarian tumour 11 ( 0.3) [0] 7 ( 0.2) [0] Gastrointestinal disorder 9 ( 0.2) [0] 9 ( 0.2) [0] Premature separation of placenta 5 ( 0.1) [0] 10 ( 0.3) [1] Hyperemesis gravidarum 6 ( 0.2) [0] 8 ( 0.2) [1] Multiple injuries 3 ( 0.1) [0] 10 ( 0.3) [0] Gestational diabetes 5 ( 0.1) [0] 6 ( 0.2) [0] Hypertension 5 ( 0.1) [0] 6 ( 0.2) [0] Ovarian cyst 5 ( 0.1) [0] 6 ( 0.2) [0] Pancreatitis acute 6 ( 0.2) [0] 5 ( 0.1) [0] Multiple pregnancy 8 ( 0.2) [0] 2 ( 0.1) [0] Placenta praevia haemorrhage 6 ( 0.2) [0] 4 ( 0.1) [0] Subcutaneous abscess 5 ( 0.1) [0] 5 ( 0.1) [0] Uterine haemorrhage 5 ( 0.1) [0] 5 ( 0.1) [0] Abdominal pain 6 ( 0.2) [0] 3 ( 0.1) [0] Foetal disorder 7 ( 0.2) [0] 2 ( 0.1) [0] Depression 5 ( 0.1) [0] 3 ( 0.1) [0] Infectious peritonitis 6 ( 0.2) [0] 2 ( 0.1) [0] Large for dates baby 4 ( 0.1) [0] 4 ( 0.1) [0] Mental disorder 5 ( 0.1) [0] 3 ( 0.1) [0] Injury 2 ( 0.1) [0] 5 ( 0.1) [0] Menometrorrhagia 5 ( 0.1) [1] 2 ( 0.1) [0] Postoperative wound complication 4 ( 0.1) [0] 3 ( 0.1) [0] Premature delivery 5 ( 0.1) [0] 2 ( 0.1) [0] Respiratory disorder 5 ( 0.1) [0] 2 ( 0.1) [0] Vaginal haemorrhage 3 ( 0.1) [0] 4 ( 0.1) [0] Pelvic inflammatory disease 3 ( 0.1) [0] 3 ( 0.1) [0] Premature labour 2 ( 0.1) [0 ] 4 ( 0.1) [2] Pyrexia 5 ( 0.1) [0] 1 ( 0.0) [0] Transverse presentation 3 ( 0.1) [0] 3 ( 0.1) [0] Abortion incomplete 4 ( 0.1) [1] 1 ( 0.0) [1] Cardiovascular disorder 5 ( 0.1) [0] 0 (0.0) [0] Cellulitis 1 ( 0.0) [0] 4 ( 0.1) [0] Concussion 2 ( 0.1) [0] 3 ( 0.1) [0] Essential hypertension 4 ( 0.1) [0] 1 ( 0.0) [0] Irritable bowel syndrome 1 ( 0.0) [0] 4 ( 0.1) [0] Salpingitis 3 ( 0.1) [0] 2 ( 0.1) [0] Staphylococcal infection 3 ( 0.1) [0] 2 ( 0.1) [0] Umbilical cord abnormality 3 ( 0.1) [0] 2 ( 0.1) [0] Breast inflammation 2 ( 0.1) [0] 2 ( 0.1) [0] Bronchopneumonia 1 ( 0.0) [0] 3 ( 0.1) [0] Eclampsia 1 ( 0.0) [0] 3 ( 0.1) [0] Endometriosis 2 ( 0.1) [0] 2 ( 0.1) [0] Lower limb fracture 2 ( 0.1) [0] 2 ( 0.1) [0] Open wound 3 ( 0.1) [0] 1 ( 0.0) [0]

17 Pelvic pain 1 ( 0.0) [0] 3 ( 0.1) [0] Perineal pain 1 ( 0.0) [0] 3 ( 0.1) [0] Retained placenta or membranes 4 ( 0.1) [0] 0 (0.0) [0] Thyroid cancer 1 ( 0.0) [0] 3 ( 0.1) [0] Type 2 diabetes mellitus 3 ( 0.1) [0] 1 ( 0.0) [0] Viral infection 1 ( 0.0) [0] 3 ( 0.1) [0] Abortion complicated 3 ( 0.1) [2] 0 (0.0) [0] Amniotic cavity infection 1 ( 0.0) [0] 2 ( 0.1) [0] Bartholin s abscess 2 ( 0.1) [0] 1 ( 0.0) [0] Bronchitis 2 ( 0.1) [0] 1 ( 0.0) [0] Calculus urinary 1 ( 0.0) [0] 2 ( 0.1) [0] Circulatory collapse 2 ( 0.1) [0] 1 ( 0.0) [0] Colitis ulcerative 2 ( 0.1) [1] 1 ( 0.0) [0] Foetal malpresentation 0 (0.0) [0] 3 ( 0.1) [0] Genital disorder female 1 ( 0.0) [0] 2 ( 0.1) [0] Humerus fracture 3 ( 0.1) [0] 0 (0.0) [0] Hyperthyroidism 2 ( 0.1) [1] 1 ( 0.0) [0] Liver disorder 0 (0.0) [0] 3 ( 0.1) [0] Lymphadenitis 2 ( 0.1) [0] 1 ( 0.0) [0] Menstruation irregular 1 ( 0.0) [0] 2 ( 0.1) [0] Migraine 2 ( 0.1) [0] 1 ( 0.0) [0] Ovarian cancer 2 ( 0.1) [0] 1 ( 0.0) [0] Physical assault 3 ( 0.1) [0] 0 (0.0) [0] Placenta praevia 2 ( 0.1) [0] 1 ( 0.0) [0] Sexually transmitted disease 1 ( 0.0) [0] 2 ( 0.1) [0] Toxicity to various agents 2 ( 0.1) [0] 1 ( 0.0) [0] Tubulointerstitial nephritis 2 ( 0.1) [0] 1 ( 0.0) [0] Uterine leiomyoma 2 ( 0.1) [0] 1 ( 0.0) [0] Anaphylactic shock 0 (0.0) [0] 2 ( 0.1) [2] Appendix disorder 2 ( 0.1) [0] 0 (0.0) [0] Asthma 2 ( 0.1) [0] 0 (0.0) [0] Bartholin s cyst 1 ( 0.0) [0] 1 ( 0.0) [0] Benign hydatidiform mole 1 ( 0.0) [0] 1 ( 0.0) [0] Blood disorder 1 ( 0.0) [0] 1 ( 0.0) [0] Cervix disorder 2 ( 0.1) [0] 0 (0.0) [0] Constipation 1 ( 0.0) [0] 1 ( 0.0) [0] Convulsion 1 ( 0.0) [0] 1 ( 0.0) [0] Gastrointestinal inflammation 1 ( 0.0) [0] 1 ( 0.0) [0] HIV infection 1 ( 0.0) [0] 1 ( 0.0) [0] Lumbar vertebral fracture 1 ( 0.0) [0] 1 ( 0.0) [0] Multiple fractures 2 ( 0.1) [0] 0 (0.0) [0] Nephrolithiasis 2 ( 0.1) [0] 0 (0.0) [0] Nervous system disorder 0 (0.0) [0] 2 ( 0.1) [0] Otitis externa 2 ( 0.1) [0] 0 (0.0) [0] Parametritis 1 ( 0.0) [0] 1 ( 0.0) [0] Phlebitis 0 (0.0) [0] 2 ( 0.1) [0] Pneumonia 2 ( 0.1) [0] 0 (0.0) [0] Polyhydramnios 1 ( 0.0) [0] 1 ( 0.0) [0] Post procedural complication 0 (0.0) [0] 2 ( 0.1) [0] Post-traumatic stress disorder 1 ( 0.0) [0] 1 ( 0.0) [0] Proteinuria 2 ( 0.1) [0] 0 (0.0) [0] Rheumatoid arthritis 1 ( 0.0) [1] 1 ( 0.0) [0] Road traffic accident 1 ( 0.0) [0] 1 ( 0.0) [0] Status asthmaticus 2 ( 0.1) [0] 0 (0.0) [0] Systemic lupus erythematosus 2 ( 0.1) [0] 0 (0.0) [0] Tension headache 1 ( 0.0) [0] 1 ( 0.0) [0]

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