Infections, Papillomavirus
Conditions
Keywords
HPV infection, Human Papillomavirus, Cervical cancer, HPV-16, HPV-18, vaccine
Brief summary
This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals' HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and 0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule (0,1,6 months) in 15-25 year old females.
Interventions
BIOLOGICALGSK Biologicals' HPV vaccine 580299
Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol or/ and subjects who the investigator believes their parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol * A female between, and including, 9 and 25 years of age at the time of the first vaccination * Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject prior to enrolment in the study. In addition, subjects below the legal age of consent should sign and personally date a written informed assent form * Healthy subjects * Female subjects of non-childbearing potential may be enrolled in the study * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire vaccination period and up to two months after the last study vaccine dose
Exclusion criteria
* Pregnant or breastfeeding * A female planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the entire vaccination period and up to two months after the last study vaccine dose * Previous vaccination against HPV or planned administration of another HPV vaccine during the study * Child in care. A child in care is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation. The definition of a child in care does not include a child who is adopted or has an appointed legal guardian. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines * Cancer or autoimmune disease under treatment * Planned administration/administration of a vaccine/product not foreseen by the study protocol within 30 days before each dose of vaccine. Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window * 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 * Previous administration of MPL or AS04 adjuvant. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period * Any confirmed or suspected immunosuppressive or immunodeficient condition * Family history of congenital or hereditary immunodeficiency * Major congenital defects or serious chronic illness * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine * Acute disease and/or fever at the time of enrolment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 | At Month 7 (i.e. one month after the last dose of study vaccine) | Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (\<) 8/7 EL.U/mL, respectively. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 | At Month 7 (i.e. one month after the last dose of study vaccine) | Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | At Day 0 and at Months 7, 12, 18, 24 and 36 | Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0, Month 7 and Month 12 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | At Day 0 and at Months 7, 12, 18, 24 and 36 | Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL. |
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | At Day 0 and at Months 13, 18, 24 and 36 | Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0 and Month 13 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | At Day 0 and at Months 13, 18, 24 and 36 | Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | At Day 0 and at Months 13, 18, 24 and 36 | Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | At Day 0 and at Months 7, 12, 18, 24 and 36 | Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30 day (Days 0-29) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group) | pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. |
| Number of Subjects With Medically Significant Conditions (MSCs) | From Day 0 up to Month 36 (throughout the study period) | MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | From Day 0 up to Month 36 (throughout the study period) | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | From Day 0 up to Month 36 (throughout the study period) | Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA. |
| Number of Subjects Completing the Vaccination Course | From Day 0 up to Month 13 | The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study. |
| Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | At Day 0 and at Months 7, 12, 24 and 36 | The CMI response represents the measure of the cytokines production \[i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)\] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | At Day 0 and at Months 7, 12, 24 and 36 | The CMI response represents the measure of the cytokines production \[IL-2, IFN-γ, TNF-α, and CD40L\] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< the cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | At Day 0 and at Months 13, 18 and 36 | The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16. The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | At Day 0 and at Months 13, 18 and 36 | The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | At Day 0 and at Months 7, 12, 24 and 36 | The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | At Day 0 and at Months 7, 12, 24 and 36 | The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | At Day 0 and at Months 13, 18 and 36 | The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group. |
| Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | At Day 0 and at Months 13, 18 and 36 | The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day period (Days 0-6) after each vaccine dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day period (Days 0-6) after each vaccine dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to the vaccination. |
Countries
Canada, Germany, Italy, Taiwan, Thailand
Participant flow
Recruitment details
This study was conducted by 33 principal investigators in five countries (Canada, Germany, Italy, Taiwan and Thailand).
Pre-assignment details
All 1447 subjects enrolled in the study were vaccinated and included in the Total vaccinated cohort (TVC).
Participants by arm
| Arm | Count |
|---|---|
| Cervarix 1 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. | 550 |
| Cervarix 2 Group Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Day 0, at Month 1 and at Month 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. | 482 |
| Cervarix 3 Group Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Day 0 and at Month 12, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm. | 415 |
| Total | 1,447 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 17 | 9 |
| Overall Study | Migrated/moved from study area | 2 | 12 | 2 |
| Overall Study | Non-Serious Adverse Event | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Serious Adverse Event | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 15 | 9 | 7 |
Baseline characteristics
| Characteristic | Cervarix 1 Group | Cervarix 2 Group | Cervarix 3 Group | Total |
|---|---|---|---|---|
| Age, Continuous | 11.6 Years STANDARD_DEVIATION 1.59 | 19.6 Years STANDARD_DEVIATION 3.05 | 11.4 Years STANDARD_DEVIATION 1.55 | 14.2 Years STANDARD_DEVIATION 4.4 |
| Race/Ethnicity, Customized African Heritage / African American | 6 Participants | 3 Participants | 6 Participants | 15 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 Participants | 1 Participants | 4 Participants | 6 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 141 Participants | 105 Participants | 74 Participants | 320 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 108 Participants | 106 Participants | 104 Participants | 318 Participants |
| Race/Ethnicity, Customized Mixed origin | 5 Participants | 4 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 288 Participants | 263 Participants | 223 Participants | 774 Participants |
| Sex: Female, Male Female | 550 Participants | 482 Participants | 415 Participants | 1447 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 / 550 | 0 / 482 | 0 / 415 |
| other Total, other adverse events | 513 / 550 | 466 / 482 | 387 / 415 |
| serious Total, serious adverse events | 20 / 550 | 28 / 482 | 24 / 415 |
Outcome results
Primary
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
Time frame: At Month 7 (i.e. one month after the last dose of study vaccine)
Population: The analysis was based on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-16 | 9400.1 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-18 | 5909.1 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-16 | 10234.5 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-18 | 5002.6 EL.U/mL |
Comparison: Immune response to anti-HPV-16 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.95% CI: [0.97, 1.22]
Comparison: Immune response to anti-HPV-18 in terms of Geometric Mean Concentrations (GMCs): To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule at 0, 6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.95% CI: [0.76, 0.95]
Primary
Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7
Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 concentrations ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with anti-HPV-16/18 antibody concentration lower than (\<) 8/7 EL.U/mL, respectively.
Time frame: At Month 7 (i.e. one month after the last dose of study vaccine)
Population: The analysis was based on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available, who were seronegative before vaccination and for whom assay results were available for antibodies against at least one study vaccine antigen component at Month 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-16 | 488 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-18 | 493 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-16 | 352 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies in Cervarix 1 Group and Cervarix 2 Group at Month 7 | Anti-HPV-18 | 382 Participants |
Comparison: Immune response to anti-HPV-16 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.95% CI: [-1.08, 0.78]
Comparison: Immune response to anti-HPV-18 in terms of seroconversion (SCR) rates: To evaluate sequentially if the immunogenicity (as determined by ELISA) of Cervarix vaccine administered according to a 2-dose schedule of 0,6 months in 9-14 year old females was non-inferior to that administered according to the standard 3-dose schedule of 0,1,6 months in 15-25 year old females, 1 month after the last dose of study vaccine, in initially seronegative subjects.95% CI: [-1, 0.77]
Secondary
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
Time frame: At Day 0 and at Months 7, 12, 18, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 18 | 1730.7 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 7 | 5935.6 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 12 | 2653.5 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 12 | 1523.6 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 24 | 1483.8 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 18 | 864.6 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 36 | 1210.2 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 24 | 715.5 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 7 | 9402.9 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 36 | 562.8 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Day 0 | 3.5 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Day 0 | 4.0 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 24 | 1575.9 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Day 0 | 4.0 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 7 | 10120.2 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 12 | 3290.4 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 18 | 1931.2 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 36 | 1326.4 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Day 0 | 3.5 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 7 | 4984.2 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 12 | 1491.5 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 18 | 830.6 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 24 | 654.3 EL.U/mL |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 36 | 552.6 EL.U/mL |
Secondary
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EL.U/mL.
Time frame: At Day 0 and at Months 13, 18, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-16, Day 0 | 4.0 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-16, Month 13 | 11329.4 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-16, Month 18 | 3248.2 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-16, Month 24 | 2191.0 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-16, Month 36 | 1559.3 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-18, Day 0 | 3.5 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-18, Month 13 | 6580.0 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-18, Month 18 | 1860.3 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-18, Month 24 | 1174.7 EL.U/mL |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations (by ELISA) in Cervarix 3 Group | Anti-HPV-18, Month 36 | 804.0 EL.U/mL |
Secondary
Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group
Antibody titers were expressed as GMTs. The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects per study group.
Time frame: At Day 0 and at Months 7, 12, 18, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 18 | 7393.6 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 7 | 24833.1 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 12 | 14872.1 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 12 | 5914.5 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 24 | 6216.5 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 18 | 3961.2 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 7 | 82975.9 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 24 | 2849.4 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 36 | 7762.7 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 36 | 2416.4 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Day 0 | 21.0 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Day 0 | 21.3 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 36 | 5063.7 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Day 0 | 23.5 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 7 | 31407.6 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 12 | 15801.8 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 18 | 8246.4 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-16, Month 24 | 7267.5 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Day 0 | 22.4 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 7 | 13935.6 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 12 | 5066.5 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 18 | 2958.2 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 24 | 2524.3 Titers |
| Cervarix 2 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers (by PBNA) in a Subset of Subjects From Cervarix 1 Group and Cervarix 2 Group | Anti-HPV-18, Month 36 | 1956.2 Titers |
Secondary
Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group
Antibody titers were expressed as geometric mean titers (GMTs). The cut-off of the assay was 40 ED50 for both anti-HPV-16 and anti-HPV-18. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
Time frame: At Day 0 and at Months 13, 18, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a subset of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-16, Day 0 | 20.0 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-16, Month 13 | 74848.0 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-16, Month 18 | 16576.6 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-16, Month 24 | 10003.7 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-16, Month 36 | 9214.3 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-18, Day 0 | 20.0 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-18, Month 13 | 39994.7 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-18, Month 18 | 9495.4 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-18, Month 24 | 5464.1 Titers |
| Cervarix 1 Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers [by Pseudovirion-Based Neutralisation Assay (PBNA)] in a Subset of Subjects From Cervarix 3 Group | Anti-HPV-18, Month 36 | 4046.4 Titers |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
The CMI response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
Time frame: At Day 0 and at Months 7, 12, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 7 | 2155.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 12 | 801.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 24 | 318.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 36 | 560.5 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 7 | 4838.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 12 | 5056.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 24 | 621.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 36 | 475.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 12 | 539.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Day 0 | 1.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Day 0 | 1.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 7 | 1510.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 36 | 107.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 12 | 1145.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 7 | 477.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 24 | 594.5 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 24 | 568.5 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 36 | 448.0 cells/million B-cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-16 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
Time frame: At Day 0 and at Months 13, 18 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 13 | 2809.5 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 18 | 766.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S-, Month 36 | 613.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 13 | 5996.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 18 | 2130.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, S+, Month 36 | 425.0 cells/million B-cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
The CMI response represents the measure of the cytokines production \[i.e. interleukin-2 (IL-2), interferon gamma (IFN-γ), tumor necrosis factor alpha (TNF-α) and the cluster of differentiation 40 Ligand (CD40L)\] by HPV-antigen specific T lymphocytes and measured by intracellular cytokine staining (ICS) assay for HPV-16. The frequency was presented as number of cytokine-positive cluster of differentiation (CD)4 i.e. CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
Time frame: At Day 0 and at Months 7, 12, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 12 | 2339.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Day 0 | 88.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 24 | 2454.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 24 | 2443.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 36 | 2135.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 36 | 7 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Day 0 | 59.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 36 | 1935.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 7 | 2474.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 7 | 3953.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 12 | 1944.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Day 0 | 57.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 24 | 2181.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 36 | 1595.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 7 | 4979.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Day 0 | 47.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 12 | 2491.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 7 | 2058.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 12 | 2587.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 12 | 1826.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 24 | 1851.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 24 | 2456.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 36 | 1138.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 24 | 2698.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Day 0 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 36 | 2109.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 7 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 36 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8 all doubles, S-, Month 12 | 30.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Day 0 | 44.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 24 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 36 | 1951.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 36 | 37.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 7 | 840.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Day 0 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 7 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 12 | 546.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8 all doubles, S+, Month 12 | 52.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Day 0 | 77.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 24 | 49.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 24 | 644.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 36 | 27.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 36 | 562.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 7 | 5019.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Day 0 | 38.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 12 | 8.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 7 | 881.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 12 | 45.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 12 | 2603.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 12 | 533.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 24 | 579.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 24 | 2552.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 36 | 651.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 24 | 8.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 36 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Day 0 | 59.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 36 | 2180.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 12 | 46.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 7 | 3808.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 24 | 8.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 12 | 2402.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Day 0 | 70.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 24 | 2477.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 36 | 1881.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 7 | 3531.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Day 0 | 68.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 7 | 4886.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 12 | 2439.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 36 | 7 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 7 | 22.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 36 | 7 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 36 | 7 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Day 0 | 14.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 7 | 22.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 12 | 23.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Day 0 | 120.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 7 | 3426.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 12 | 2278.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 24 | 2401.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 36 | 2073.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Day 0 | 100.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 7 | 1820.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 12 | 1423.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 24 | 1404.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 36 | 1310.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Day 0 | 97.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 7 | 3196.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 12 | 2255.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 24 | 2344.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 36 | 2027.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Day 0 | 72.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 7 | 1655.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 12 | 1412.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 24 | 1285.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 36 | 1279.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Day 0 | 39.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 7 | 657.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 12 | 362.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 24 | 449.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 36 | 391.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Day 0 | 50.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 7 | 489.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 12 | 329.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 24 | 310.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 36 | 564.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Day 0 | 85.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 7 | 3212.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 12 | 2184.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 24 | 2282.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 36 | 1922.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Day 0 | 77.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 7 | 1573.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 12 | 1372.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 24 | 1226.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 36 | 1243.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Day 0 | 68.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 7 | 2575.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 12 | 1726.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 24 | 1970.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 36 | 1390.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Day 0 | 64.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 7 | 1273.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 12 | 1171.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 24 | 1061.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 36 | 1057.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Day 0 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 7 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8 all doubles, S-, Month 12 | 29.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 24 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 36 | 35.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Day 0 | 35.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 7 | 33.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8 all doubles, S+, Month 12 | 29.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 24 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 36 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 12 | 15.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 36 | 25.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Day 0 | 31.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 12 | 15.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T Cell-mediated Immune Response (CMI) for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 24 | 7.0 cells/million T cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
The CMI response represents the measure of the cytokines production (IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-16. The frequency was presented as a number of cytokine-positive cluster of differentiation (CD)4 i.e.CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles= T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
Time frame: At Day 0 and at Months 13, 18 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Day 0 | 96.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 13 | 2399.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 18 | 1879.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S-, Month 36 | 1786.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Day 0 | 169.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 13 | 2507.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 18 | 2717.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4 all doubles, S+, Month 36 | 1521.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Day 0 | 89.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 13 | 2356.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 18 | 1831.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S-, Month 36 | 1763.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Day 0 | 141.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 13 | 2450.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 18 | 2614.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-CD40L, S+, Month 36 | 1426.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Day 0 | 35.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 13 | 651.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 18 | 405.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S-, Month 36 | 646.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Day 0 | 68.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 13 | 644.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 18 | 708.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IFNγ, S+, Month 36 | 310.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Day 0 | 63.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 13 | 2220.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 18 | 1830.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S-, Month 36 | 1670.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Day 0 | 121.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 13 | 2442.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 18 | 2659.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-IL-2, S+, Month 36 | 1028.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Day 0 | 63.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 13 | 1643.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 18 | 1326.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S-, Month 36 | 1300.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Day 0 | 140.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 13 | 1843.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 18 | 2085.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD4-d-TNFα, S+, Month 36 | 1202.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Day 0 | 27.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 13 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 18 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S-, Month 36 | 21.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Day 0 | 33.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 13 | 43.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 18 | 27.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-all doubles, S+, Month 36 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 13 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 13 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-CD40L, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 13 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Day 0 | 29.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 13 | 25.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IFNγ, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 13 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 13 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-IL-2, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 13 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 18 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 13 | 20.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 18 | 20.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-16 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-16, CD8-d-TNFα, S+, Month 36 | 7.0 cells/million T cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
Time frame: At Day 0 and at Months 7, 12, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 7 | 958.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 24 | 236.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 36 | 269.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 7 | 2016.5 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 24 | 299.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 36 | 154.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 36 | 93.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Day 0 | 1.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Day 0 | 1.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 7 | 817.5 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 24 | 338.5 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 24 | 274.0 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 7 | 439.5 cells/million B-cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 36 | 284.5 cells/million B-cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
The cell-mediated immune response was assessed as being the frequency of B-cell memory of HPV-18 antigen-specific memory B-cells per million memory B-cells in subjects with detectable B-cells. The results are presented by pre-vaccination status, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination and S+ = seropositive subjects (antibody concentration ≥ cut off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
Time frame: At Day 0 and at Months 13, 18 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Day 0 | 1.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 13 | 1165.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 18 | 561.5 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S-, Month 36 | 361.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Day 0 | 48.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 13 | 758.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 18 | 938.0 cells/million B-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific B CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, S+, Month 36 | 1231.0 cells/million B-cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects
The CMI response represents the measure of the cytokines production \[IL-2, IFN-γ, TNF-α, and CD40L\] by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< the cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects per study group.
Time frame: At Day 0 and at Months 7, 12, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects per study group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 24 | 710.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 36 | 808.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 36 | 45.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Day 0 | 62.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 7 | 2634.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 12 | 1967.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 24 | 1632.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 36 | 1543.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Day 0 | 121.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 7 | 1419.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 12 | 830.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 24 | 652.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 36 | 794.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Day 0 | 32.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 7 | 562.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 12 | 354.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 12 | 16.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 24 | 326.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 36 | 304.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Day 0 | 55.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 7 | 628.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 12 | 244.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 24 | 295.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 36 | 356.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Day 0 | 57.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 7 | 2611.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 12 | 1959.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 24 | 1638.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 36 | 17.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 36 | 1495.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Day 0 | 65.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 7 | 1470.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 12 | 847.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 24 | 652.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 36 | 777.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Day 0 | 49.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 7 | 1699.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Day 0 | 86.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 12 | 1573.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 24 | 1434.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 7 | 2780.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 36 | 1268.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Day 0 | 51.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 12 | 2039.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 7 | 1337.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 12 | 34.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 12 | 604.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 24 | 1815.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 24 | 601.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 36 | 652.5 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 36 | 1609.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Day 0 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 7 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Day 0 | 125.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8 all doubles, S-, Month 12 | 28.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 24 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 7 | 1593.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 36 | 32.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 36 | 25.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Day 0 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 12 | 868.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 7 | 11.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8 all doubles, S+, Month 12 | 44.0 cells/million T cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 24 | 19.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8 all doubles, S+, Month 12 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 24 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 36 | 34.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 7 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 12 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 24 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 36 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Day 0 | 7.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Day 0 | 112.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 7 | 1864.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 12 | 1246.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 24 | 1355.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 36 | 1246.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Day 0 | 128.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 7 | 1498.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 12 | 787.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 24 | 885.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 36 | 598.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Day 0 | 88.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 7 | 1700.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 12 | 1206.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 24 | 1290.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 36 | 1222.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Day 0 | 110.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 7 | 1377.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 12 | 767.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 24 | 867.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 36 | 594.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Day 0 | 32.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 7 | 350.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 12 | 216.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 24 | 205.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 36 | 233.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Day 0 | 28.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 7 | 376.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 12 | 161.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 24 | 270.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 36 | 239.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Day 0 | 81.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 7 | 1725.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 12 | 1172.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 24 | 1306.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 36 | 1183.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Day 0 | 96.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 7 | 1231.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 12 | 783.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 24 | 705.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 36 | 554.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Day 0 | 73.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 7 | 1394.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 12 | 991.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 24 | 1102.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 36 | 868.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Day 0 | 68.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 7 | 1137.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 12 | 684.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 24 | 768.5 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 36 | 444.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Day 0 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 7 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8 all doubles, S-, Month 12 | 37.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 24 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 36 | 29.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Day 0 | 11.0 cells/million T cells |
| Cervarix 2 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 1 Group and Cervarix 2 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 7 | 11.0 cells/million T cells |
Secondary
Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects
The CMI response represents the measure of the cytokines production (i.e. IL-2, IFN-γ, TNF-α, and CD40L) by HPV-antigen specific T lymphocytes and measured by ICS assay for HPV-18. The frequency was presented as a number of cytokine-producing CD4+/CD8+ cells per million CD4+/CD8+ cells. All doubles = T cell expressing at least 2 cytokines. Results were tabulated by the pre-vaccination status of the subjects, where S- = seronegative subjects (antibody concentration \< cut-off value) prior to vaccination. S+ = seropositive subjects (antibody concentration ≥ cut-off value) prior to vaccination. The assay was performed on a subset of 100 subjects from Cervarix 3 Group.
Time frame: At Day 0 and at Months 13, 18 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included a sub-cohort of 100 subjects from Cervarix 3 Group, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Day 0 | 99.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 13 | 1499.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 18 | 1222.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S-, Month 36 | 1158.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Day 0 | 107.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 13 | 1968.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 18 | 1250.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4 all doubles, S+, Month 36 | 1399.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Day 0 | 82.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 13 | 1472.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 18 | 1199.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S-, Month 36 | 1154.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Day 0 | 103.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 13 | 1904.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 18 | 1174.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-CD40L, S+, Month 36 | 1320.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Day 0 | 35.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 13 | 349.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 18 | 226.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S-, Month 36 | 318.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Day 0 | 33.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 13 | 378.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 18 | 157.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IFNγ, S+, Month 36 | 389.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Day 0 | 58.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 13 | 1398.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 18 | 1102.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S-, Month 36 | 1086.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Day 0 | 46.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 13 | 1845.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 18 | 1151.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-IL-2, S+, Month 36 | 1160.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Day 0 | 60.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 13 | 1029.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 18 | 921.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S-, Month 36 | 812.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Day 0 | 66.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 13 | 1449.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 18 | 954.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD4-d-TNFα, S+, Month 36 | 1127.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Day 0 | 11.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 13 | 32.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 18 | 34.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S-, Month 36 | 33.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Day 0 | 29.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 13 | 63.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 18 | 11.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-all doubles, S+, Month 36 | 45.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Day 0 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 13 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S-, Month 36 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Day 0 | 25.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 13 | 21.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-CD40L, S+, Month 36 | 41.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Day 0 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 13 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S-, Month 36 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Day 0 | 25.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 13 | 59.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IFNγ, S+, Month 36 | 41.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Day 0 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 13 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S-, Month 36 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Day 0 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 13 | 45.5 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-IL-2, S+, Month 36 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Day 0 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 13 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S-, Month 36 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Day 0 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 13 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 18 | 7.0 cells/million T-cells |
| Cervarix 1 Group | Cell-mediated Immunogenicity Related to Anti-HPV-18 Specific T CMI Response for Cervarix 3 Group in a Sub-cohort of Subjects | Anti-HPV-18, CD8-d-TNFα, S+, Month 36 | 7.0 cells/million T-cells |
Secondary
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36
Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0, Month 7 and Month 12 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.
Time frame: At Day 0 and at Months 7, 12, 18, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Day 0 | 0 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 7 | 455 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 12 | 455 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 18 | 453 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 24 | 454 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 36 | 455 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Day 0 | 0 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 7 | 462 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 12 | 462 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 18 | 458 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 24 | 459 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 36 | 461 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 24 | 352 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Day 0 | 0 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Day 0 | 0 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 7 | 330 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 18 | 355 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 12 | 330 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 7 | 356 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 18 | 329 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 36 | 355 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 24 | 326 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-18, Month 12 | 356 Participants |
| Cervarix 2 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 1 Group and Cervarix 2 Group at Day 0 and at Months 7, 12, 18, 24 and 36 | Anti-HPV-16, Month 36 | 330 Participants |
Secondary
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group
Seroconversion was defined as the appearance of antibodies (anti-HPV-16 concentrations ≥ 8 EL.U/mL and anti-HPV-18 concentrations ≥ 7 EL.U/mL \[applicable for Day 0 and Month 13 time points\] and anti-HPV-16 concentrations ≥ 19 EL.U/mL and anti-HPV-18 concentrations ≥ 18 EL.U/mL \[applicable for Month 18, Month 24 and Month 36 time points\]) in the serum of subjects seronegative before vaccination. A seronegative subject was a subject with an anti-HPV-16/18 antibody concentration below (\<) the aforementioned cut-offs. Note: In order to increase the ELISA precision, the assay cut-off value was changed from 8 EL.U/mL to 19 EL.U/mL for HPV-16 and from 7 EL.U/mL to 18 EL.U/mL for HPV-18 from Month 18 onwards.
Time frame: At Day 0 and at Months 13, 18, 24 and 36
Population: The analysis was based on the Month 36 ATP cohort for immunogenicity which included all subjects seronegative before vaccination, who returned for blood sampling at Month 36 and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination at the specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-16, Day 0 | 0 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-16, Month 13 | 339 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-16, Month 18 | 339 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-16, Month 24 | 337 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-16, Month 36 | 339 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-18, Day 0 | 0 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-18, Month 13 | 355 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-18, Month 18 | 355 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-18, Month 24 | 353 Participants |
| Cervarix 1 Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies in Cervarix 3 Group | Anti-HPV-18, Month 36 | 355 Participants |
Secondary
Number of Subjects Completing the Vaccination Course
The number of subjects completing the vaccination course was assessed as the number of subjects with at least one dose received during the study.
Time frame: From Day 0 up to Month 13
Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix 1 Group | Number of Subjects Completing the Vaccination Course | 550 Participants |
| Cervarix 2 Group | Number of Subjects Completing the Vaccination Course | 482 Participants |
| Cervarix 3 Group | Number of Subjects Completing the Vaccination Course | 415 Participants |
Secondary
Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Outcomes of reported pregnancies were: Ectopic pregnancy, Elective termination NO apparent congenital anomaly (ACA), Live Infant NO ACA, Stillbirth NO ACA.
Time frame: From Day 0 up to Month 36 (throughout the study period)
Population: The analysis was based on the TVC, which included all subjects with the study vaccine administered and who reported any pregnancies and outcomes of reported pregnancies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Ectopic pregnancy | 0 Participants |
| Cervarix 1 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Elective termination NO ACA | 0 Participants |
| Cervarix 1 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Live Infant NO ACA | 1 Participants |
| Cervarix 1 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Stillbirth NO ACA | 0 Participants |
| Cervarix 2 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Stillbirth NO ACA | 1 Participants |
| Cervarix 2 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Ectopic pregnancy | 1 Participants |
| Cervarix 2 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Live Infant NO ACA | 30 Participants |
| Cervarix 2 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Elective termination NO ACA | 2 Participants |
| Cervarix 3 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Stillbirth NO ACA | 0 Participants |
| Cervarix 3 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Elective termination NO ACA | 0 Participants |
| Cervarix 3 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Live Infant NO ACA | 1 Participants |
| Cervarix 3 Group | Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies | Ectopic pregnancy | 0 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 pain = significant pain at rest, that prevented normal every day activity. Grade 3 redness/swelling = redness/swelling above 50 millimeters (mm).
Time frame: During the 7-day period (Days 0-6) after each vaccine dose and across doses
Population: The analysis was based on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available and symptom sheet completed. Subjects from Cervarix 1 and Cervarix 3 Groups received only 2 doses of vaccine, therefore data are presented up to Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 1 | 461 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 1 | 24 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 2 | 446 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 2 | 33 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Across doses | 499 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Across doses | 50 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 1 | 167 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 1 | 0 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 2 | 180 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 2 | 4 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Across doses | 247 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Across doses | 4 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 1 | 141 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 1 | 3 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 2 | 166 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 2 | 2 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Across doses | 225 Participants |
| Cervarix 1 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Across doses | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 1 | 135 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 1 | 439 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Across doses | 53 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Across doses | 204 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 1 | 21 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 2 | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 1 | 1 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 2 | 377 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 2 | 4 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 3 | 142 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 2 | 25 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 3 | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 3 | 358 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 3 | 20 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 3 | 136 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Across doses | 461 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Across doses | 212 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 2 | 131 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 2 | 143 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 3 | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Across doses | 10 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 1 | 2 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Across doses | 6 Participants |
| Cervarix 2 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 1 | 105 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 1 | 354 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Across doses | 48 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 2 | 135 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 1 | 126 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Across doses | 6 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 1 | 2 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Dose 2 | 153 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 2 | 2 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Dose 2 | 1 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness - Across doses | 197 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness - Across doses | 3 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Dose 1 | 101 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 1 | 21 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Dose 2 | 323 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling - Dose 1 | 4 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain - Dose 2 | 31 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling - Across doses | 171 Participants |
| Cervarix 3 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain - Across doses | 381 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever and urticaria. Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever greater than (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to the vaccination.
Time frame: During the 7-day period (Days 0-6) after each vaccine dose and across doses
Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available and symptom sheet completed. Subjects from Cervarix 1 and Cervarix 3 Groups received only 2 doses of vaccine, therefore data are presented up to Dose 2.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 1 | 59 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 1 | 8 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 1 | 56 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 2 | 71 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 2 | 2 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 2 | 64 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Across doses | 111 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Across doses | 9 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Across doses | 105 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 1 | 181 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 1 | 7 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 1 | 153 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 2 | 167 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 2 | 9 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 2 | 149 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Across doses | 247 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Across doses | 14 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Across doses | 221 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 1 | 61 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 1 | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 1 | 49 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 2 | 51 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 2 | 6 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 2 | 34 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Across doses | 98 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Across doses | 7 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Across doses | 77 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 1 | 133 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 1 | 9 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 1 | 104 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 2 | 128 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 2 | 14 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 2 | 107 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Across doses | 204 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Across doses | 19 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Across doses | 176 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 1 | 206 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 1 | 16 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 1 | 191 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 2 | 196 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 2 | 13 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 2 | 182 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Across doses | 278 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Across doses | 24 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Across doses | 265 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 1 | 17 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 1 | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 1 | 13 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 2 | 17 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 2 | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 2 | 13 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Across doses | 33 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Across doses | 2 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Across doses | 26 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 1 | 24 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 1 | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 1 | 15 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 2 | 21 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 2 | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 2 | 17 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Across doses | 41 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Across doses | 2 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Across doses | 29 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 1 | 9 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 1 | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 1 | 7 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 2 | 7 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 2 | 6 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Across doses | 15 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Across doses | 1 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Across doses | 13 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 3 | 8 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 1 | 53 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Across doses | 48 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 3 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 1 | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Across doses | 26 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 3 | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 1 | 50 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 3 | 7 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Across doses | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 2 | 56 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 3 | 35 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Across doses | 25 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 2 | 1 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Across doses | 219 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 1 | 161 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 2 | 50 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 3 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 3 | 49 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 3 | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 3 | 42 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 2 | 9 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Across doses | 107 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 1 | 236 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Across doses | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Across doses | 6 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 2 | 7 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Across doses | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Across doses | 102 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 1 | 12 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 2 | 12 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 1 | 238 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 1 | 10 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Across doses | 18 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 1 | 9 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 1 | 223 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Across doses | 134 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 1 | 205 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 3 | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Across doses | 1 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 2 | 168 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 2 | 182 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 1 | 17 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 2 | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 2 | 36 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Across doses | 39 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 2 | 142 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 2 | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 3 | 177 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 3 | 12 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 3 | 161 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Across doses | 310 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 1 | 136 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 1 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Across doses | 25 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 2 | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 2 | 171 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Across doses | 294 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 3 | 29 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 3 | 158 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 1 | 88 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 3 | 8 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 1 | 12 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 1 | 2 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 3 | 150 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 2 | 129 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 1 | 67 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Across doses | 295 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Across doses | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 2 | 50 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 2 | 15 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 1 | 7 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Across doses | 25 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 3 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 2 | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Across doses | 285 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 2 | 2 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Across doses | 15 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 1 | 8 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 3 | 25 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 1 | 1 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 1 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 2 | 108 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 3 | 45 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 1 | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 3 | 124 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 3 | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 2 | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 3 | 106 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 1 | 3 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 2 | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 3 | 5 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Across doses | 246 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 2 | 10 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Across doses | 106 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 2 | 48 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 2 | 4 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 2 | 25 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 2 | 40 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Across doses | 77 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Across doses | 7 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 2 | 1 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Across doses | 62 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 2 | 8 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 1 | 128 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 1 | 10 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 2 | 18 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 1 | 104 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Dose 2 | 130 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Dose 2 | 6 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Dose 2 | 100 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache - Across doses | 185 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache - Across doses | 16 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Across doses | 42 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache - Across doses | 148 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 1 | 160 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 1 | 8 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Across doses | 1 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 1 | 140 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Dose 2 | 150 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Dose 2 | 10 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Across doses | 32 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Dose 2 | 136 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Across doses | 12 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia - Across doses | 221 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia - Across doses | 15 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 1 | 4 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia - Across doses | 201 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 1 | 15 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 1 | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 1 | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 1 | 13 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Across doses | 13 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Dose 2 | 16 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Dose 2 | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria - Dose 1 | 4 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Dose 2 | 16 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 1 | 52 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 1 | 3 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 1 | 45 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Dose 2 | 64 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Dose 2 | 3 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash - Across doses | 29 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Dose 2 | 57 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Artharlgia - Across doses | 93 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia - Across doses | 6 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash - Across doses | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia - Across doses | 83 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria - Dose 2 | 9 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 1 | 156 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 1 | 10 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash - Across doses | 28 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 1 | 129 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Dose 2 | 144 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Dose 2 | 14 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever - Dose 1 | 18 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Dose 2 | 119 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue - Across doses | 215 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue - Across doses | 21 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever - Dose 1 | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue - Across doses | 185 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal - Dose 1 | 44 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal - Dose 1 | 3 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever - Dose 1 | 15 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal - Dose 1 | 32 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria - Across doses | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 = unsolicited AE preventing normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Time frame: During the 30 day (Days 0-29) post-vaccination period
Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 2 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 97 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 11 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 17 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 167 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 24 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 74 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 13 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 6 Participants |
Secondary
Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time frame: From Day 0 up to Month 13 (for Cervarix 1 Group and Cervarix 2 Group) and from Day 0 up to Month 18 (for Cervarix 3 Group)
Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available. The data for Cervarix 1 and 2 Groups are only presented up to Month 13, as the data were only collected up to Month 13 for those 2 groups.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | Any pIMDs, from Day 0 up to Month 13 | 2 Participants |
| Cervarix 2 Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | Any pIMDs, from Day 0 up to Month 13 | 2 Participants |
| Cervarix 3 Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | Any pIMDs, from Day 0 up to Month 13 | 2 Participants |
| Cervarix 3 Group | Number of Subjects With Any Potential Immune-Mediated Diseases (pIMDs) | Any pIMDs, from Day 0 up to Month 18 | 2 Participants |
Secondary
Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as causally related to the study vaccination.
Time frame: From Day 0 up to Month 36 (throughout the study period)
Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix 1 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Any SAEs | 20 Participants |
| Cervarix 1 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Fatal SAEs | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Any SAEs | 28 Participants |
| Cervarix 2 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Fatal SAEs | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Any SAEs | 24 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Fatal SAEs | 0 Participants |
| Cervarix 3 Group | Number of Subjects With Any, Related and Fatal Serious Adverse Events (SAEs) | Related SAEs | 1 Participants |
Secondary
Number of Subjects With Medically Significant Conditions (MSCs)
MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 up to Month 36 (throughout the study period)
Population: The analysis was based on the TVC, which included all vaccinated subjects who received at least one dose of vaccine and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix 1 Group | Number of Subjects With Medically Significant Conditions (MSCs) | 134 Participants |
| Cervarix 2 Group | Number of Subjects With Medically Significant Conditions (MSCs) | 153 Participants |
| Cervarix 3 Group | Number of Subjects With Medically Significant Conditions (MSCs) | 87 Participants |