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Uterine Cervical Neoplasms

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Vaccines

Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.

Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.

GSK Biologicals' HPV vaccine 580299

GSK Clinical Trials

This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.

Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' HPV-16/18 L1 AS04 Vaccine When Administered According to Alternative 2-dose Schedules in 9 - 14 Year Old Females

IPD for this study will be made available via the Clinical Study Data Request site.

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (\<) 8/7 EL.U/mL, respectively.

Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0, Month 7 and Month 12 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination.

A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs.

Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.

Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0 and Month 13 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination.

A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs.

Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.

Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.

The CMI response represents the measure of the cytokines production \[i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)\] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

The CMI response represents the measure of the cytokines production \[IL-2, IFN-γ, TNF-α, and CD40L\] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< the cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16. The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm).

Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to the vaccination.

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 = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.

pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are 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.

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity grade or relation to vaccination.

Related = SAE assessed by the investigator as causally related to the study vaccination.

Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.

The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.

GlaxoSmithKline

The occurrence of reported AEs (all/related) was not available and encoded as equal to the number of subjects affected. For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Cervarix 1 Group

Cervarix 2 Group

Cervarix 3 Group

Total

Age, Continuous

Sex: Female, Male

African Heritage / African American

Asian - Central/South Asian Heritage

Asian - East Asian Heritage

Asian - South East Asian Heritage

White - Arabic / North African Heritage

White - Caucasian / European Heritage

Mixed origin

Race/Ethnicity, Customized

GSK Response Center

Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.

Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.

Anti-HPV-16

Anti-HPV-18

The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.

Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7

Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.

Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.

The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7

Anti-HPV-16, Day 0

Anti-HPV-16, Month 7

Anti-HPV-16, Month 12

Anti-HPV-16, Month 18

Anti-HPV-16, Month 24

Anti-HPV-16, Month 36

Anti-HPV-18, Day 0

Anti-HPV-18, Month 7

Anti-HPV-18, Month 12

Anti-HPV-18, Month 18

Anti-HPV-18, Month 24

Anti-HPV-18, Month 36

The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36

Anti-HPV-16, Month 13

Anti-HPV-18, Month 13

Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group

Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group

The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group

The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group

Anti-HPV-16, CD4 all doubles, S-, Day 0

Anti-HPV-16, CD4 all doubles, S-, Month 7

Anti-HPV-16, CD4 all doubles, S-, Month 12

Anti-HPV-16, CD4 all doubles, S-, Month 24

Anti-HPV-16, CD4 all doubles, S-, Month 36

Anti-HPV-16, CD4 all doubles, S+, Day 0

Anti-HPV-16, CD4 all doubles, S+, Month 7

Anti-HPV-16, CD4 all doubles, S+, Month 12

Anti-HPV-16, CD4 all doubles, S+, Month 24

Anti-HPV-16, CD4 all doubles, S+, Month 36

Anti-HPV-16, CD4-d-CD40L, S-, Day 0

Anti-HPV-16, CD4-d-CD40L, S-, Month 7

Anti-HPV-16, CD4-d-CD40L, S-, Month 12

Anti-HPV-16, CD4-d-CD40L, S-, Month 24

Anti-HPV-16, CD4-d-CD40L, S-, Month 36

Anti-HPV-16, CD4-d-CD40L, S+, Day 0

Anti-HPV-16, CD4-d-CD40L, S+, Month 7

Anti-HPV-16, CD4-d-CD40L, S+, Month 12

Anti-HPV-16, CD4-d-CD40L, S+, Month 24

Anti-HPV-16, CD4-d-CD40L, S+, Month 36

Anti-HPV-16, CD4-d-IFNγ, S-, Day 0

Anti-HPV-16, CD4-d-IFNγ, S-, Month 7

Anti-HPV-16, CD4-d-IFNγ, S-, Month 12

Anti-HPV-16, CD4-d-IFNγ, S-, Month 24

Anti-HPV-16, CD4-d-IFNγ, S-, Month 36

Anti-HPV-16, CD4-d-IFNγ, S+, Day 0

Anti-HPV-16, CD4-d-IFNγ, S+, Month 7

Anti-HPV-16, CD4-d-IFNγ, S+, Month 12

Anti-HPV-16, CD4-d-IFNγ, S+, Month 24

Anti-HPV-16, CD4-d-IFNγ, S+, Month 36

Anti-HPV-16, CD4-d-IL-2, S-, Day 0

Anti-HPV-16, CD4-d-IL-2, S-, Month 7

Anti-HPV-16, CD4-d-IL-2, S-, Month 12

Anti-HPV-16, CD4-d-IL-2, S-, Month 24

Anti-HPV-16, CD4-d-IL-2, S-, Month 36

Anti-HPV-16, CD4-d-IL-2, S+, Day 0

Anti-HPV-16, CD4-d-IL-2, S+, Month 7

Anti-HPV-16, CD4-d-IL-2, S+, Month 12

Anti-HPV-16, CD4-d-IL-2, S+, Month 24

Anti-HPV-16, CD4-d-IL-2, S+, Month 36

Anti-HPV-16, CD4-d-TNFα, S-, Day 0

Anti-HPV-16, CD4-d-TNFα, S-, Month 7

Anti-HPV-16, CD4-d-TNFα, S-, Month 12

Anti-HPV-16, CD4-d-TNFα, S-, Month 24

Anti-HPV-16, CD4-d-TNFα, S-, Month 36

Anti-HPV-16, CD4-d-TNFα, S+, Day 0

Anti-HPV-16, CD4-d-TNFα, S+, Month 7

Anti-HPV-16, CD4-d-TNFα, S+, Month 12

Anti-HPV-16, CD4-d-TNFα, S+, Month 24

Anti-HPV-16, CD4-d-TNFα, S+, Month 36

Anti-HPV-16, CD8-all doubles, S-, Day 0

Anti-HPV-16, CD8-all doubles, S-, Month 7

Anti-HPV-16, CD8 all doubles, S-, Month 12

Anti-HPV-16, CD8-all doubles, S-, Month 24

Anti-HPV-16, CD8-all doubles, S-, Month 36

Anti-HPV-16, CD8-all doubles, S+, Day 0

Anti-HPV-16, CD8-all doubles, S+, Month 7

Anti-HPV-16, CD8 all doubles, S+, Month 12

Anti-HPV-16, CD8-all doubles, S+, Month 24

Anti-HPV-16, CD8-all doubles, S+, Month 36

Anti-HPV-16, CD8-d-CD40L, S-, Day 0

Anti-HPV-16, CD8-d-CD40L, S-, Month 7

Anti-HPV-16, CD8-d-CD40L, S-, Month 12

Anti-HPV-16, CD8-d-CD40L, S-, Month 24

Anti-HPV-16, CD8-d-CD40L, S-, Month 36

Anti-HPV-16, CD8-d-CD40L, S+, Day 0

Anti-HPV-16, CD8-d-CD40L, S+, Month 7

Anti-HPV-16, CD8-d-CD40L, S+, Month 12

Anti-HPV-16, CD8-d-CD40L, S+, Month 24

Anti-HPV-16, CD8-d-CD40L, S+, Month 36

Anti-HPV-16, CD8-d-IFNγ, S-, Day 0

Anti-HPV-16, CD8-d-IFNγ, S-, Month 7

Anti-HPV-16, CD8-d-IFNγ, S-, Month 12

Anti-HPV-16, CD8-d-IFNγ, S-, Month 24

Anti-HPV-16, CD8-d-IFNγ, S-, Month 36

Anti-HPV-16, CD8-d-IFNγ, S+, Day 0

Anti-HPV-16, CD8-d-IFNγ, S+, Month 7

Anti-HPV-16, CD8-d-IFNγ, S+, Month 12

Anti-HPV-16, CD8-d-IFNγ, S+, Month 24

Anti-HPV-16, CD8-d-IFNγ, S+, Month 36

Anti-HPV-16, CD8-d-IL-2, S-, Day 0

Anti-HPV-16, CD8-d-IL-2, S-, Month 7

Anti-HPV-16, CD8-d-IL-2, S-, Month 12

Anti-HPV-16, CD8-d-IL-2, S-, Month 24

Anti-HPV-16, CD8-d-IL-2, S-, Month 36

Anti-HPV-16, CD8-d-IL-2, S+, Day 0

Anti-HPV-16, CD8-d-IL-2, S+, Month 7

Anti-HPV-16, CD8-d-IL-2, S+, Month 12

Anti-HPV-16, CD8-d-IL-2, S+, Month 24

Anti-HPV-16, CD8-d-IL-2, S+, Month 36

Anti-HPV-16, CD8-d-TNFα, S-, Day 0

Anti-HPV-16, CD8-d-TNFα, S-, Month 7

Anti-HPV-16, CD8-d-TNFα, S-, Month 12

Anti-HPV-16, CD8-d-TNFα, S-, Month 24

Anti-HPV-16, CD8-d-TNFα, S-, Month 36

Anti-HPV-16, CD8-d-TNFα, S+, Day 0

Anti-HPV-16, CD8-d-TNFα, S+, Month 7

Anti-HPV-16, CD8-d-TNFα, S+, Month 12

Anti-HPV-16, CD8-d-TNFα, S+, Month 24

Anti-HPV-16, CD8-d-TNFα, S+, Month 36

The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.

Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

Anti-HPV-18, CD4 all doubles, S-, Day 0

Anti-HPV-18, CD4 all doubles, S-, Month 7

Anti-HPV-18, CD4 all doubles, S-, Month 12

Anti-HPV-18, CD4 all doubles, S-, Month 24

Anti-HPV-18, CD4 all doubles, S-, Month 36

Anti-HPV-18, CD4 all doubles, S+, Day 0

Anti-HPV-18, CD4 all doubles, S+, Month 7

Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls	NCT01381575	Infections, Pap...	GSK Biologicals...	9 Years - 25 Years	GlaxoSmithKline
Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females	NCT01031069	Infections, Pap... Papillomavirus ...	GSK Biologicals... Merck's Human P...	15 Years - 25 Years	GlaxoSmithKline
Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls	NCT01381575	Infections, Pap...	GSK Biologicals...	9 Years - 25 Years	GlaxoSmithKline

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