Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, rash, temperature [defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.

An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.

Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophilis [BSPH], creatinine [CRT], eosinophils [ESPH], haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP], monocytes [MONO], neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.

CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.

HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.

HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification [WHO, 2009].

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Month 7.

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects.

Between-group comparisons to assess non-inferiority were performed on the ATP cohort for immunogenicity (by PBNA, regardless of HPV serostatus at baseline).

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom Month 7 data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity at Month 7 were available.

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], in HIV+ subjects.

Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).

The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.

Assessed solicited local symptoms were pain, redness, swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 50 millimeters (mm).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal [nausea, vomiting, diarrhoea and/or abdominal pain], headache, myalgia, rash, temperature [defined as axillary temperature higher than (>) 37.5 degrees Celsius (°C)] and urticaria. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature > 39.0 °C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had available symptom sheets completed.

An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Pregnancy related outcomes were: live infant no apparent congenital anomaly, live infant congenital anomaly, elective termination (termin.) no apparent congenital anomaly, elective termination (termin.) congenital anomaly, ectopic pregnancy, spontaneous abortion no apparent congenital (congen.) anomaly, stillbirth no apparent congenital anomaly, stillbirth congenital anomaly, lost to follow-up, pregnancy ongoing, missing.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who reported any pregnancies and outcomes of reported pregnancies.

Among assessed haematological and biochemical parameters were: alanine aminotransferase [ALAT], basophils [BSPH], creatinine [CRT], eosinophils [ESPH]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7*, Month 12, Month 18 and Month 24.

* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.

Among assessed haematological parameters were: haematocrit [HTCR], haemoglobin [HGB], lymphocytes [LYMP] and monocytes [MONO]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7*, Month 12, Month 18 and Month 24.

* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.

Among assessed haematological parameters were: neutrophils [NTPH], platelets [PLAT], red blood cells [RBC] and white blood cells [WBC]. Unknown = value unknown for the specified visit and laboratory parameter; Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Day 0, Week 6, Week 10, Month 6, Month 7*, Month 12, Month 18 and Month 24.

* Month 7 data for HIV+/Cervarix and HIV+/Gardasil groups are also reported in the Primary outcome measure.

SAEs assessed include any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or represented a congenital anomaly/birth defect in the offspring of a study subject.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Medically significant conditions (MSCs) are defined as AEs prompting emergency room or physician visits that were not related to common diseases, or not related to routine visits for physical examination or vaccination, SAEs that were not related to common diseases.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

Potential immune-mediated diseases are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analysis was performed on the Total Vaccinated cohort for analysis of safety, which included all subjects with at least one vaccine administration documented.

CD4+ cell count, expressed in cells/cubic millimeter (mm3), was assessed for HIV+ subjects.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.

HIV VL, expressed in HIV copies/milliliter (mL), was assessed for HIV+ subjects.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.

HIV+ subjects were categorised into clinical stages 1 through 4, as per the WHO classification [WHO, 2009].

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available at Months 12, 18 and 24.

Titers of anti-HPV-16/18 antibodies, expressed as Geometric Mean Titers (GMTs), with cut-offs greater than or equal to (≥) 40 estimated dose giving 50% signal reduction when compared to a control without serum (ED50), as assessed by the Pseudovirion-Based Neutralization Assay [PBNA], for HIV- subjects.

Between-group comparisons to assess superiority were performed on the TVC (by PBNA, regardless of HPV serostatus at baseline).

The analysis was performed on the TVC for analysis of immunogenicity, which included vaccinated subjects for whom data concerning immunogenicity endpoint measures were available at Month 7.

Anti-HPV-16 and anti-HPV-18 antibody concentrations in serum, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 19 ELISA units per milliliter (EU/mL) and 18 EU/mL respectively, as assessed by Enzyme-linked immunosorbent assay (ELISA), in all (HIV+ and HIV-) subjects.

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

Anti-HPV-16 and anti-HPV-18 antibody concentrations in CVS, are presented as Geometric Mean Concentrations (GMCs), with cut-offs greater than or equal to (≥) 0 EU/mL, as assessed by ELISA, in post-menarcheal subjects who volunteered for this procedure.

The analysis was performed on the Adapted ATP cohort for immunogenicity, which included post-menarcheal subjects who volunteered for this procedure, met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

B-cell memory was assessed by Enzyme Linked Immuno Spot (ELISPOT) assay. The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).

The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-),who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.

The combinations of cytokines expressed were CD4/8-all doubles, CD4/8-d-cluster of differentiation 40 Ligand (CD40L), CD4/8-d-interferon gamma (IFNG), CD4/8-interleukin-2 (IL-2), CD4/8-d-tumour necrosis alpha (TNFA), as assessed by Intracellular cytokine staining (ICS). The assay was performed in a subset of approximately 100 subjects (50 HIV+ and 50 HIV-).

The analysis was performed on the Adapted ATP cohort for immunogenicity,which included subjects in a subset of approximately 100 subjects(50 HIV+ and 50 HIV-) who met all eligibility criteria and for whom data concerning immunogenicity endpoint measures obtained from the ATP cohort for immunogenicity corresponding to each time point were available.