| Primary | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT record NCT00518336. The immune response data for the HPV-008 study can be found under the NCT record NCT00122681. | The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Years 5, 6 and 7 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
| | | Title | Denominators | Categories |
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| Anti-HPV-16 [Year 5] | - ParticipantsOG000128
- ParticipantsOG001127
- ParticipantsOG002118
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| Primary | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16/18 antibody titers are presented as Geometric Mean Titers (GMTs) and expressed in EL.U/mL. The immune response of the HPV-16/18 vaccine (as determined by anti-HPV-16/18 antibodies assessed by ELISA) in the HPV-060 study population was compared with the immune response obtained in study HPV-001 and its long-term follow-up studies HPV-007/HPV-023 at equivalent timepoints and with the immune response obtained after natural infection in subjects from study HPV-008. The immune response data for the efficacy studies HPV-001/HPV-007/HPV-023 can be found under the NCT number NCT00518336. The immune response data for the HPV-008 study can be found under the NCT number NCT00122681. | The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 8, 9 and 10 were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Years 8, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | |
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| Primary | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | Seroconversion was defined as the appearance of anti-HPV-16 and anti- HPV-18 antibodies [i.e. antibody titer greater than or equal to (≥) the cut-off value] in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 8 EL.U/mL for anti-HPV-16 antibody titers and 7 EL.U/mL for anti-HPV-18 antibody titers. | The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 5, 6 and 7 were available. | Posted | | Count of Participants | | Participants | | At Years 5, 6 and 7 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Primary | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | Seroconversion was defined as the appearance of anti-HPV-16 and anti-HPV-18 antibodies (i.e. antibody titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination in the primary study HPV-014 (NCT00196937). Cut-off values were 19 EL.U/mL for anti-HPV-16 antibody titers and 18 EL.U/mL for anti-HPV-18 antibody titers. | The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937), who were seronegative before vaccination and for whom immunogenicity data at Years 8, 9 and 10 were available. | Posted | | Count of Participants | | Participants | | At Years 8, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | |
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| Secondary | Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects | Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL. | Analysis was performed on a subset of subjects from the Total Vaccinated Cohort (TVC), who volunteered for CVS sample collection at Years 5 and 6 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Year 5 and Year 6 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL. | Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Years 7, 8, 9 and 10 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At Years 7, 8, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL). | Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Year 5 and Year 6 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Year 5 and Year 6 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL). | Analysis was performed on a subset of subjects from the TVC, who volunteered for CVS sample collection at Years 7, 8, 9, 10 and for whom the collected CVS sample contained less than 200 erythrocytes per microliter. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Years 7, 8, 9 and 10 | | | | ID | Title | Description |
|---|
| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. | The analysis was performed on the ATP cohort for immunogenicity at Years 5, 6 and 7, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937) and for whom immunogenicity data at Years 5, 6 and 7 were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Years 5, 6 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. | The analysis was performed on the ATP cohort for immunogenicity at Years 8, 9 and 10, which included all evaluable subjects from the ATP cohort for immunogenicity of the primary study HPV-014 (NCT00196937) and for whom immunogenicity data at Years 8, 9 and 10 were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Years 8, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. | The analysis was performed on the TVC at Years 5, 6 and 7, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data at Years 5, 6 and 7 were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Years 5, 6 and 7 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. | The analysis was performed on the Total Vaccinated Cohort at Years 8, 9 and 10, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data at Years 8, 9 and 10 were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At Years 8, 9 and 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG002 | Cervarix 46-55 Years Group | Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 4 in Primary Study HPV-014 (NCT00196937) to Year 5 in the Present Study | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was based on the TVC at Year 5, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available at Year 5. | Posted | | Count of Participants | | Participants | | From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 5 to Year 6 | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was based on the TVC at Year 6, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available at Year 6. | Posted | | Count of Participants | | Participants | | From Year 5 up to Year 6 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 6 to Year 7 | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was based on the TVC at Year 7, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available at Year 7. | Posted | | Count of Participants | | Participants | | From Year 6 up to Year 7 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 7 to Year 8 | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was based on the TVC at Year 8, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available at Year 8. | Posted | | Count of Participants | | Participants | | From Year 7 up to Year 8 | | | | ID | Title | Description |
|---|
| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 8 to Year 9 | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was based on the TVC at Year 9, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available at Year 9. | Posted | | Count of Participants | | Participants | | From Year 8 up to Year 9 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 9 to Year 10 | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was based on the TVC at Year 10, which included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available at Year 10. | Posted | | Count of Participants | | Participants | | From Year 9 up to Year 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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| Secondary | Number of Subjects With Any Fatal or Vaccine-related SAEs (Including SAEs Related to Study Procedures and GlaxoSmithKline Biologicals' Concomitant Medication) From Year 0 to Year 10 | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Related SAE = SAE assessed by the investigator as causally related to the study vaccine administered in study HPV-014 (NCT00196937). | The analysis was performed on the TVC that included all vaccinated subjects [i.e. all subjects who received 3 doses of HPV vaccine in the primary study HPV-014 (NCT00196937)] for whom data were available throughout the study. | Posted | | Count of Participants | | Participants | | From Year 0 up to Year 10 | | | | ID | Title | Description |
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| OG000 | Cervarix 15-25 Years Group | Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). | | OG001 | Cervarix 26-45 Years Group | Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study HPV-014 (NCT00196937). |
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