Intramuscular injection, 3 doses

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.

The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at Month 10 and Month 12 is reported.

The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) [RNA copies/mL (in log10)].

The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).

CD4+ cell count categories, at baseline, assessed were (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

CD4+ cell count categories, at baseline, assessed were: (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above (>) 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.

Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The CMI response is the measure of the cytokines production [i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Total of all reporting groups

Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Solicited general symptoms assessed were arthralgia, fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal, headache, myalgia, rash and urticaria. Any = occurrence of any solicited general symptom regardless of their intensity grade or relationship. Grade 3 Symptom = symptom that prevented normal activity. Grade 3 Urticaria = Urticaria distributed on at least 4 body areas. Related = symptom assessed by the investigator as causally related to the vaccination.

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

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 AE = an AE which prevented normal, everyday activities. Related = AE 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.

Medically significant conditions (MSCs) were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

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

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

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

The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

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

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or a congenital anomaly/birth defect in the offspring of a study subject.

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

MSCs were collected regardless of causal relationship to vaccination and intensity. Medically significant conditions were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.

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

The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies. The outcome of the reported pregnancy was a live infant with no apparent congenital anomaly.

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

Haematological laboratory parameters assessed were red blood cells (RBC) and platelets (PLA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Haematological laboratory parameters assessed were white blood cells (WBC) and neutrophils (NEU). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Haematological laboratory parameters assessed were lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Haematological laboratory parameters assessed were haemoglobin (Hgb) and haematocrit (Hct). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Haematological and biochemical laboratory parameters assessed were eosinophils (EOS), basophils (BAS) and creatinine (CREA). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Biochemical laboratory parameter assessed was alanine aminotransferase (ALAT). By pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Haematological laboratory parameters assessed were neutrophils (NEU), platelets (PLA), red blood cells (RBC) and white blood cells (WBC). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

Haematological and biochemical laboratory parameters assessed were alanine aminotransferase (ALAT), basophils (BAS), creatinine (CREA), eosinophils (EOS), haematocrit (Hct), haemoglobin (Hgb), lymphocytes (LYM) and monocytes (MON). For each parameter and by pre-vaccination status, it was assessed whether the post-vaccination values of the parameter were above, below or in the normal range (missing values are also indicated).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom assay results were available at the considered time points.

The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at pre-vaccination (Day 0) and Months 1, 2, 4, 6 and 7 is reported.

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

The number of CD4+ cells per cubic millimeter (mm^3) in all HIV+ subjects at Month 10 and Month 12 is reported.

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

The viral load was calculated by estimating the amount of virus in blood samples and it was given in number of Ribonucleic acid copies per milliliter (in log10) [RNA copies/mL (in log10)].

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

The viral load was calculated by estimating the amount of virus in blood samples and was given in number of RNA copies/mL (in log 10).

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

CD4+ cell count categories, at baseline, assessed were (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

CD4+ cell count categories, at baseline, assessed were: (i) below (<) 200 CD4+ cells per cubic millimeter (mm^3), (ii) between 200 and 500 CD4+ cells/mm^3 and (iii) above (>) 500 CD4+ cells/mm^3. WHO classification of HIV-associated clinical disease: 1 = Asymptomatic HIV-associated symptoms = WHO clinical stage 1; 2 = Mild HIV-associated symptoms = WHO clinical stage 2; 3 = Advanced HIV-associated symptoms = WHO clinical stage 3; 4 = Severe HIV-associated symptoms = WHO clinical stage 4.

The analysis was performed on the Total Vaccinated cohort, which included all HIV+ vaccinated subjects for whom data were available at the considered time points.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 EL.U/mL and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the According-to-Protocol (ATP) cohort for immunogenicity regardless of baseline serostatus.

The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titers ≥ 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 titers ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject is a subject whose antibody titers are below the cut-off value. Due to the high proportion of initially seropositive subjects in the study population, seroconversion rates were considered for all subjects in the ATP cohort for immunogenicity regardless of baseline serostatus.

The analysis was performed on ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

The analysis was performed on the ATP cohort for immunogenicity (Month 7), which included all evaluable subjects up to Month 7 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Concentrations are expressed as geometric mean antibody concentrations (GMCs) and are given in EL.U/mL. The antibody concentrations against HPV-16 and HPV-18 were determined by Enzyme-linked immunosorbent assay (ELISA). The cut-off values of the assay are 8 EL.U/mL for anti-HPV-16 and 7 EL.U/mL for anti-HPV-18.

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

The CMI response is expressed by the number of subjects with B-cell response to VLP-16 and VLP-18 above (>) 0 as measured by Flow cytometry.

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

The CMI response is the measure of the cytokines production [i.e. Cluster of Differentiation 40 Ligand (CD40L), Interferon gamma (IFN-γ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNF-α)] by HPV-antigen specific T lymphocytes and measured by Intracellular Cytokine Staining (ICS) assay. The results were expressed as a frequency of positive CD4 or CD8 T-cell producing at least 1 cytokine within the CD4 or CD8 T-cell sub-population. All doubles = T cell expressing at least 2 cytokines.

The analysis was performed on the ATP cohort for immunogenicity (Month 12), which included all evaluable subjects up to Month 12 for whom immunogenicity data were available at the considered time points. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component post-vaccination.

Human immunodeficiency virus positive (HIV+) female subjects who received 3 doses of control Aluminium Hydroxide [Al(OH)3], administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

Human immunodeficiency virus negative (HIV-) subjects who received 3 doses of Cervarix vaccine administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.

up to Month 12

up to Month 12

up to Month 12

up to Month 12

up to Month 12

up to Month 12