Infections, Papillomavirus
Conditions
Keywords
Cervical cancer, HPV vaccine
Brief summary
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The objectives & outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).
Detailed description
Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was administered in this extension study. Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.
Interventions
PROCEDUREBlood sampling
Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.
PROCEDURECervico-vaginal secretion (CVS) samples
CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believed that they could and would comply with the requirements of the protocol. * A female who had been enrolled in NCT00196937 study and received three doses of HPV-16/18 vaccine. * Written informed consent obtained from the subject.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) or planned use during the study period. * Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs occurring less than three months prior to blood sampling. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling. * Administration or planned administration of any HPV vaccine, other than the three doses of HPV-16/18 vaccine administered in NCT00196937 study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | 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. |
| Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | 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. |
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | 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. |
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | At Years 5, 6 and 7 | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. |
| Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | At Years 8, 9 and 10 | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. |
| Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | At Years 5, 6 and 7 | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. |
| Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | At Years 8, 9 and 10 | Total IgG antibody titers are presented as GMTs and expressed in µg/mL. |
| 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 | From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 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). |
| Anti-HPV-16/18 Secretion Antibody Titers in Cervico-vaginal Secretion (CVS) Samples at Years 5 and 6 in a Subset of Subjects | At Year 5 and Year 6 | Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL. |
| 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 | From Year 6 up 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). |
| 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 | From Year 7 up 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). |
| 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 | From Year 8 up 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). |
| 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 | From Year 9 up 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). |
| 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 | From Year 0 up 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). |
| 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 | From Year 5 up 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). |
| Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | At Years 7, 8, 9 and 10 | Anti-HPV-16/18 titers in CVS samples are presented as GMTs and expressed in EL.U/mL. |
| Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | At Year 5 and Year 6 | IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL). |
| Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | At Years 7, 8, 9 and 10 | Total IgG antibody titers in CVS samples are presented as GMTs and expressed in microgram per milliliter (µg/mL). |
Countries
Germany, Poland
Participant flow
Recruitment details
This study was conducted at six centers in Germany and Poland.
Pre-assignment details
Out of the 525 enrolled subjects, 1 subject was excluded for not receiving vaccination and the actual starting number was 524.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 159 |
| 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). | 194 |
| 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). | 171 |
| Total | 524 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 11 | 12 | 8 |
| Overall Study | Migrated from study area | 2 | 0 | 0 |
| Overall Study | Missed reporting interval | 3 | 4 | 2 |
| Overall Study | Physician Decision | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 4 |
Baseline characteristics
| Characteristic | Cervarix 15-25 Years Group | Cervarix 26-45 Years Group | Cervarix 46-55 Years Group | Total |
|---|---|---|---|---|
| Age, Continuous | 25.7 Years STANDARD_DEVIATION 2.82 | 41.0 Years STANDARD_DEVIATION 6.02 | 54.4 Years STANDARD_DEVIATION 3.15 | 40.9 Years STANDARD_DEVIATION 12.22 |
| Race/Ethnicity, Customized Black | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 159 Participants | 193 Participants | 171 Participants | 523 Participants |
| Sex: Female, Male Female | 159 Participants | 194 Participants | 171 Participants | 524 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 159 | 1 / 194 | 1 / 171 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 159 | 2 / 194 | 1 / 171 |
Outcome results
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.
Time frame: At Years 8, 9 and 10
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 8] | 1123.3 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 9] | 980.9 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 10] | 965.4 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 8] | 375.1 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 9] | 327.4 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 10] | 321.1 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 10] | 115.4 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 8] | 392.1 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 8] | 134.1 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 9] | 122.5 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 9] | 366.5 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 10] | 334.4 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 9] | 180.2 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 10] | 157.4 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 10] | 69.7 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 8] | 82.6 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-16 [Year 8] | 189.1 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Antibody Titers in Serum at Years 8, 9 and 10 | Anti-HPV-18 [Year 9] | 75.6 EL.U/mL |
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.
Time frame: At Years 5, 6 and 7
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 5] | 1495.7 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 6] | 1344.6 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 7] | 1014.0 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 5] | 440.4 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 6] | 438.2 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 7] | 307.8 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 7] | 119.8 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 5] | 518.7 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 5] | 168.8 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 6] | 167.5 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 6] | 526.0 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 7] | 369.5 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 6] | 277.7 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 7] | 201.4 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 7] | 81.7 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 5] | 104.6 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-16 [Year 5] | 282.4 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-Human Papillomavirus (Anti-HPV)-16/18 Antibody Titers in Serum at Years 5, 6 and 7 | Anti-HPV-18 [Year 6] | 97.6 EL.U/mL |
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.
Time frame: At Years 5, 6 and 7
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 5] | 128 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 6] | 128 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 7] | 125 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 5] | 134 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 6] | 133 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 7] | 130 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 7] | 135 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 5] | 127 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 5] | 144 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 6] | 146 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 6] | 130 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 7] | 119 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 6] | 116 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 7] | 111 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 7] | 131 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 5] | 143 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-16 [Year 5] | 118 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 5, 6 and 7 | anti-HPV-18 [Year 6] | 138 Participants |
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.
Time frame: At Years 8, 9 and 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 8] | 116 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 9] | 127 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 10] | 123 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 8] | 120 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 9] | 132 Participants |
| Cervarix 15-25 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 10] | 126 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 10] | 133 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 8] | 106 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 8] | 118 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 9] | 141 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 9] | 132 Participants |
| Cervarix 26-45 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 10] | 120 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 9] | 106 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 10] | 103 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 10] | 109 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 8] | 104 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-16 [Year 8] | 95 Participants |
| Cervarix 46-55 Years Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies at Years 8, 9 and 10 | anti-HPV-18 [Year 9] | 113 Participants |
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.
Time frame: At Year 5 and Year 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 [Year 5] | 90.2 EL.U/mL |
| Cervarix 15-25 Years Group | 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-18 [Year 5] | 30.9 EL.U/mL |
| Cervarix 15-25 Years Group | 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 [Year 6] | 80.3 EL.U/mL |
| Cervarix 15-25 Years Group | 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-18 [Year 6] | 22.9 EL.U/mL |
| Cervarix 26-45 Years Group | 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-18 [Year 6] | 19.9 EL.U/mL |
| Cervarix 26-45 Years Group | 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 [Year 5] | 47.2 EL.U/mL |
| Cervarix 26-45 Years Group | 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 [Year 6] | 43.8 EL.U/mL |
| Cervarix 26-45 Years Group | 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-18 [Year 5] | 24.6 EL.U/mL |
| Cervarix 46-55 Years Group | 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-18 [Year 6] | 19.2 EL.U/mL |
| Cervarix 46-55 Years Group | 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-18 [Year 5] | 33.3 EL.U/mL |
| Cervarix 46-55 Years Group | 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 [Year 6] | 37.1 EL.U/mL |
| Cervarix 46-55 Years Group | 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 [Year 5] | 56.8 EL.U/mL |
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.
Time frame: At Years 7, 8, 9 and 10
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 10] | 29.4 EL.U/mL |
| Cervarix 15-25 Years Group | 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 [Year 7] | 63.0 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 8] | 17.8 EL.U/mL |
| Cervarix 15-25 Years Group | 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 [Year 10] | 43.4 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 7] | 33.5 EL.U/mL |
| Cervarix 15-25 Years Group | 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 [Year 9] | 67.7 EL.U/mL |
| Cervarix 15-25 Years Group | 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 [Year 8] | 45.6 EL.U/mL |
| Cervarix 15-25 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 9] | 28.1 EL.U/mL |
| Cervarix 26-45 Years Group | 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 [Year 8] | 43.9 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 7] | 17.5 EL.U/mL |
| Cervarix 26-45 Years Group | 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 [Year 10] | 34.3 EL.U/mL |
| Cervarix 26-45 Years Group | 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 [Year 7] | 33.3 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 10] | 22.7 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 9] | 23.9 EL.U/mL |
| Cervarix 26-45 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 8] | 26.2 EL.U/mL |
| Cervarix 26-45 Years Group | 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 [Year 9] | 42.6 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 10] | 45.1 EL.U/mL |
| Cervarix 46-55 Years Group | 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 [Year 7] | 42.3 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 7] | 49.0 EL.U/mL |
| Cervarix 46-55 Years Group | 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 [Year 8] | 54.6 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 8] | 31.9 EL.U/mL |
| Cervarix 46-55 Years Group | Anti-HPV-16/18 Secretion Antibody Titers in CVS Samples at Years 7, 8, 9 and 10 in a Subset of Subjects | Anti-HPV-18 [Year 9] | 50.4 EL.U/mL |
| Cervarix 46-55 Years Group | 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 [Year 10] | 56.0 EL.U/mL |
| Cervarix 46-55 Years Group | 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 [Year 9] | 62.6 EL.U/mL |
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).
Time frame: From Year 0 up to Year 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 1 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 1 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 1 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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).
Time frame: From Year 4 in primary study HPV-014 (NCT00196937) up to Year 5 in present HPV-060 study
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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).
Time frame: From Year 5 up to Year 6
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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).
Time frame: From Year 6 up to Year 7
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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).
Time frame: From Year 7 up to Year 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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).
Time frame: From Year 8 up to Year 9
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 1 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 1 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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).
Time frame: From Year 9 up to Year 10
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 15-25 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 15-25 Years Group | 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 | Related SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 26-45 Years Group | 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 | Related SAE(s) | 1 Participants |
| Cervarix 46-55 Years Group | 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 | Fatal SAE(s) | 0 Participants |
| Cervarix 46-55 Years Group | 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 | Related SAE(s) | 0 Participants |
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.
Time frame: At Years 5, 6 and 7
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 6] | 13376.5 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 5] | 19481.8 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 7] | 13957.2 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 6] | 12262.7 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 5] | 18388.2 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 7] | 13179.4 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 5] | 17657.2 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 7] | 12992.9 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 6] | 12040.2 µg/mL |
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.
Time frame: At Years 5, 6 and 7
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 6] | 13318.5 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 5] | 19453.0 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 7] | 13957.2 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 6] | 12173.1 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 5] | 18092.4 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 7] | 13059.5 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 5] | 17885.0 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 7] | 13052.9 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 5, 6 and 7 Based on the TVC | Total IgG serum antibodies [Year 6] | 12040.2 µg/mL |
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.
Time frame: At Years 8, 9 and 10
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 9] | 11212.2 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 8] | 11059.5 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 10] | 11071.3 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 9] | 10693.8 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 8] | 10656.3 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 10] | 10650.8 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 8] | 10605.7 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 10] | 10535.0 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the ATP Cohort for Immunogenicity | Total IgG serum antibodies [Year 9] | 10427.8 µg/mL |
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.
Time frame: At Years 8, 9 and 10
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 9] | 11212.2 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 8] | 11084.4 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 10] | 11043.6 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 9] | 10693.8 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 8] | 10602.4 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 10] | 10511.3 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 8] | 10725.5 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 10] | 10484.8 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Antibody Titers in Serum at Years 8, 9 and 10 Based on the TVC | Total IgG serum antibodies [Year 9] | 10427.8 µg/mL |
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).
Time frame: At Years 7, 8, 9 and 10
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 7] | 517.5 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 8] | 304.8 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 9] | 435.1 µg/mL |
| Cervarix 15-25 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 10] | 315.3 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 10] | 373.5 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 7] | 372.2 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 9] | 460.4 µg/mL |
| Cervarix 26-45 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 8] | 457.2 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 10] | 622.9 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 8] | 928.2 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 9] | 925.8 µg/mL |
| Cervarix 46-55 Years Group | Total IgG Secretion Antibody Titers in CVS Samples at Years 7, 8, 9, and 10 in a Subset of Subjects | IgG secretion antibodies [Year 7] | 1263.2 µg/mL |
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).
Time frame: At Year 5 and Year 6
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 15-25 Years Group | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG secretion antibodies [Year 5] | 577.8 µg/mL |
| Cervarix 15-25 Years Group | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG secretion antibodies [Year 6] | 546.5 µg/mL |
| Cervarix 26-45 Years Group | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG secretion antibodies [Year 5] | 550.5 µg/mL |
| Cervarix 26-45 Years Group | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG secretion antibodies [Year 6] | 499.8 µg/mL |
| Cervarix 46-55 Years Group | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG secretion antibodies [Year 5] | 990.6 µg/mL |
| Cervarix 46-55 Years Group | Total Immunoglobulin G (IgG) Secretion Antibody Titers in CVS Samples at Years 5 and 6 in a Subset of Subjects | IgG secretion antibodies [Year 6] | 1012.9 µg/mL |