Infections, Papillomavirus, Papillomavirus Vaccines
Conditions
Keywords
Vaccine, Human papillomavirus, Cervical Cancer, Cervical Infection
Brief summary
This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.
Detailed description
The Protocol Posting has been updated due to protocol amendment 5 and in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALCervarix
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
BIOLOGICALPlacebo control
Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
26 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A woman who the investigator believes that she can and will comply with the requirements of the protocol. * A women of at least 26 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to enrolment. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Subject must have intact cervix. * Subject must have a negative urine pregnancy test. This test is not applicable to women of non-childbearing potential. * Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using an effective method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions for two months after completion of the vaccination series.
Exclusion criteria
* Pregnant or breastfeeding (women must be at least three months post-pregnancy and not breastfeeding to enter the study). * A women planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose (Month 0 - 8). * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 84). * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e. days 0 - 29) the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * Previous administration of components of the investigational vaccine * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * History of HPV infection/treatment or planned treatment to evaluate an abnormal cervical cytology (Pap smear) test, e.g. colposcopy. * Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * Hypersensitivity to latex. * Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * History of chronic condition(s) requiring treatment. * Administration of immunoglobulins and/or any blood product within three months preceding the first dose of study vaccine, or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window. * Acute disease at the time of enrolment. * Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic exam cannot be performed (and no cervical sample can be taken). Enrolment will be deferred until condition is resolved according to investigators medical judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | Up to Month 48 | CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) * Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus |
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Up to Month 48 | CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Up to Month 48 | Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | Up to Month 48 | Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68 |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to Month 48 | CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed. |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to Month 48 | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | Up to Month 48 | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | Up to Month 48 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed. |
| Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | Up to Month 48 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 |
| Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | Up to Month 48 | Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With First Colposcopy | Up to Month 48 | Detection was done on all subjects irrespective of their baseline HPV DNA status. |
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | Up to Month 48 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. |
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | Up to Month 48 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types) |
| Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region |
| Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region |
| Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 | GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) |
| Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Up to Month 48 | Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. |
| Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84. | Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50% |
| Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84. | Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50% |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Within 7 days (Days 0-6) after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm). |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Within 7 days (Days 0-6) after vaccination | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Within 30 days (Days 0 - 29) post-vaccination period. | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Up to Month 48 and up to Month 84 | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Up to Month 84 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study. | Up to Month 84 | 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. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects Reporting New Onset of Chronic Disease (NOCDs). | Up to Month 48 | NOCDs include autoimmune disorders, asthma and type I diabetes. |
| Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs). | Up to Month 48 | — |
| Number of Subjects Reporting Medically Significant Conditions (MAEs). | Up to Month 48 | Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Pregnancies and Their Outcomes. | Up to Month 48 | Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA). |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | Up to Month 48 | CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if 1. the same HPV type was found in at least one of the two (closest) preceding cytology samples, or 2. none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types) |
| Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84 | GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region) |
| Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | Up to Month 48 | Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. |
Countries
Australia, Canada, Mexico, Netherlands, Peru, Philippines, Portugal, Russia, Singapore, Thailand, United Kingdom, United States
Participant flow
Recruitment details
Some subjects completed the study at Months 36 and 48 as they did not want to participate to the extensions up to Month 84, but they were included in the safety analysis for these subsequent timepoints.
Pre-assignment details
Enrolment was stratified by (1) age, with the majority of subjects in age strata 26 - 35 years and 36 - 45 years (about 45% each) and about 10% in the age stratum 46+ years, and (2) previous HPV history (in each age stratum, the number of women with a history of HPV infection/treatment was limited to approximately 15%).
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. | 2,881 |
| Aluminium Hydroxide Group Subjects received 3 doses of Aluminium Hydroxide \[Al(OH)3\]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule. | 2,871 |
| Total | 5,752 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 48 | Adverse Event | 28 | 13 |
| Month 48 | Lost to Follow-up | 272 | 287 |
| Month 48 | Other | 10 | 14 |
| Month 48 | Protocol Violation | 4 | 4 |
| Month 48 | Withdrawal by Subject | 111 | 115 |
| Month 84 | Absent Cervix | 2 | 0 |
| Month 84 | Adverse Event | 4 | 2 |
| Month 84 | Center closed, subject did not transfer | 1 | 0 |
| Month 84 | Family problems | 2 | 2 |
| Month 84 | Lack of time | 3 | 1 |
| Month 84 | Lost to Follow-up | 187 | 190 |
| Month 84 | No consent for Month 84 Follow-up | 731 | 754 |
| Month 84 | Personal reason | 2 | 4 |
| Month 84 | Protocol Violation | 1 | 1 |
| Month 84 | Subject does not want male physician | 1 | 0 |
| Month 84 | Transport reimbursement delayed | 0 | 1 |
| Month 84 | Unable to reach study site | 1 | 0 |
| Month 84 | Under investigation locally | 1 | 0 |
| Month 84 | Visit missed | 0 | 1 |
| Month 84 | Withdrawal by Subject | 33 | 31 |
| Month 84 | Work related reasons | 4 | 2 |
Baseline characteristics
| Characteristic | Cervarix Group | Aluminium Hydroxide Group | Total |
|---|---|---|---|
| Age, Continuous | 37.0 Years STANDARD_DEVIATION 7.24 | 37.0 Years STANDARD_DEVIATION 7.32 | 37.0 Years STANDARD_DEVIATION 7.28 |
| Sex: Female, Male Female | 2881 Participants | 2871 Participants | 5752 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2,543 / 2,881 | 2,236 / 2,871 |
| serious Total, serious adverse events | 291 / 2,881 | 269 / 2,871 |
Outcome results
Primary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero- subjects | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero+ subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, overall | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero- subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, overall | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, overall | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero- subjects | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, overall | 15 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero- subjects | 36 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero- subjects | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero- subjects | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero+ subjects | 12 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero+ subjects | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero+ subjects | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, overall | 49 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, overall | 35 Participants |
Primary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
CIN1+ = CIN grades 1, 2 and 3, AIS and invasive cervical cancer. Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero+ subjects | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero+ subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, overall | 10 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, overall | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, overall | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero- subjects | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero- subjects | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero- subjects | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero- subjects | 53 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, overall | 28 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, DNA- and sero+ subjects | 9 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero+ subjects | 14 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero+ subjects | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, DNA- and sero- subjects | 71 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18, overall | 88 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18, DNA- and sero- subjects | 20 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16, overall | 62 Participants |
Primary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) * Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero- subjects | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero+ subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, overall | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero- subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, overall | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, overall | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero- subjects | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, overall | 16 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero- subjects | 36 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero- subjects | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero- subjects | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero+ subjects | 14 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero+ subjects | 9 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero+ subjects | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, overall | 51 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, overall | 36 Participants |
Primary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection.
CIN1+ = CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Persistent HPV infection = detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and 6 and seronegative/positive (sero-/+) at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Month 0 and 6 for the corresponding HPV-type, regardless of initial serostatus
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero- subjects | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero+ subjects | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, overall | 10 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero- subjects | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, overall | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero+ subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, overall | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero- subjects | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, overall | 29 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero- subjects | 71 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero- subjects | 53 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero- subjects | 20 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, DNA- and sero+ subjects | 16 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, DNA- and sero+ subjects | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-18, DNA- and sero+ subjects | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16/18, overall | 90 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection. | HPV-16, overall | 63 Participants |
Secondary
Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset.
GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)
Time frame: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero-before vaccination | NA EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 7 | 5412.9 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 12 | 1542.5 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 18 | 992.6 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 24 | 827.8 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 36 | 612.9 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 48 | 546.2 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 60 | 447.1 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 72 | 412.8 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 84 | 381.0 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ before vaccination | 39.3 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 7 | 5845.5 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at month 12 | 2705.8 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 18 | 2104.7 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 24 | 1883.5 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at month 36 | 1363.8 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 48 | 1261.2 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 60 | 943.0 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 72 | 1053.7 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 84 | 954.3 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 60 | 24.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero-before vaccination | NA EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ before vaccination | 38.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 7 | 4.3 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at month 36 | 30.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 12 | 4.4 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 7 | 33.4 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 18 | 4.1 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 84 | 23.9 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 24 | 4.2 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at month 12 | 38.0 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 36 | 4.5 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 48 | 34.3 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 48 | 4.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 18 | 30.5 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 60 | 4.3 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 72 | 25.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 72 | 9.8 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero+ at Month 24 | 29.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-16 Antibody in the Immunogenicity Subset. | Sero- at Month 84 | 9.6 EL.U/mL |
Secondary
Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset.
GMCs were expressed in ELISA units per milliliter (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites (N≥1000, at least 250 per region)
Time frame: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- before vaccination | NA EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 7 | 2567.7 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 12 | 645.3 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 18 | 402.6 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 24 | 321.7 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 36 | 245.9 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 48 | 228.5 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 60 | 174.3 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 72 | 177.7 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 84 | 166.2 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ before vaccination | 23.0 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 7 | 2933.9 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 12 | 936.2 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 18 | 661.3 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 24 | 573.6 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 36 | 423.1 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 48 | 392.3 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 60 | 306.0 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 72 | 324.8 EL.U/mL |
| Cervarix Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 84 | 302.2 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 60 | 12.9 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- before vaccination | NA EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ before vaccination | 24.2 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 7 | 3.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 36 | 16.4 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 12 | 3.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 7 | 21.9 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 18 | 3.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 84 | 16.5 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 24 | 3.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 12 | 23.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 36 | 3.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 48 | 15.9 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 48 | 3.7 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 18 | 19.5 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 60 | 3.8 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 72 | 16.2 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 72 | 9.2 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero+ at Month 24 | 16.6 EL.U/mL |
| Aluminium Hydroxide Group | Geometric Mean Concentrations (GMCs) Against HPV-18 Antibody in the Immunogenicity Subset. | Sero- at Month 84 | 9.1 EL.U/mL |
Secondary
Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects.
Titers are expressed as geometric mean antibody titers (GMTs). Seronegative (Sero-) subjects are subjects who had an antibody titer below 40 ED50 prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody titer equal to or above 40 ED50 prior to vaccination. ED50 = Estimated dose 50%, the estimated serum dilution reducing the signal generated by viral infection by 50%
Time frame: Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 7] | 3014.5 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 7] | 11663.5 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 12] | 5597.7 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 18] | 2175.2 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 24] | 1941.7 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 48] | 828.9 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 84] | 1213.4 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [pre-vaccination] | 139.3 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 7] | 20283.2 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 12] | 19484.3 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 18] | 4393.3 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 24] | 9459.1 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 48] | 4187.2 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 84] | 5837.0 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [pre-vaccination] | NA Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 7] | 7959.6 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 12] | 1979.9 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 18] | 1334.6 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 24] | 826.6 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 48] | 386.1 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 84] | 491.2 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [pre-vaccination] | 84.7 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [pre-vaccination] | NA Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 12] | 3377.8 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 18] | 3125.8 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 24] | 2493.0 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 48] | 545.0 Titers |
| Cervarix Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 84] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 12] | 167.3 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [pre-vaccination] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 7] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 7] | 20.8 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 12] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 12] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 18] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 18] | 254.9 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 24] | 22.3 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [pre-vaccination] | 45.0 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 48] | 21.4 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 24] | 21.4 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero- [at Month 84] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 24] | 154.9 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 48] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 7] | 107.0 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 18] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 12] | 99.0 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [at Month 84] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 18] | 93.0 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 48] | 86.0 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 24] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [pre-vaccination] | 115.5 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 48] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 7] | 163.4 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 84] | NA Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 84] | 968.0 Titers |
| Aluminium Hydroxide Group | Geometric Mean Titers (GMTs) Against HPV-16 and HPV-18 Viral Neutralization Antibodies in a Selected Subset of Subjects. | HPV-18 sero- [pre-vaccination] | NA Titers |
Secondary
Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects.
Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16/18 assay cut-off value was defined as greater than or equal to 40 Estimated dose 50% (ED50). Sero- subjects are subjects who had an antibody concentration below 40 ED50 prior to vaccination. Sero+ subjects are subjects who had an antibody concentration equal to or above 50 ED50 prior to vaccination. ED50 = the estimated serum dilution reducing the signal generated by viral infection by 50%
Time frame: Prior to vaccination and at Months 7, 12, 18, 24, 48 and 84.
Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 48] | 1 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 12] | 37 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 18] | 36 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 24] | 35 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 48] | 27 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 84] | 19 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [pre-vaccination] | 4 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 7] | 4 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 12] | 4 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 18] | 4 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 24] | 4 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 48] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 84] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [pre-vaccination] | 0 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [pre-vaccination] | 0 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 48] | 29 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 84] | 22 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [pre-vaccination] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 7] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 12] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 18] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 24] | 3 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 84] | 1 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 7] | 38 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 12] | 38 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 18] | 37 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 24] | 36 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 7] | 37 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 18] | 2 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 7] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [pre-vaccination] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 12] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 24] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 18] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 7] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 24] | 2 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 48] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 48] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 24] | 2 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero- [at Month 84] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 84] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [pre-vaccination] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 48] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 7] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [pre-vaccination] | 3 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 12] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 18] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 18] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 7] | 2 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 24] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 84] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 48] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero+ [at Month 12] | 2 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-16 sero+ [at Month 84] | 1 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [at Month 12] | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 and HPV-18 Viral Neutralization in a Selected Subset of Subjects. | HPV-18 sero- [pre-vaccination] | 0 Participants |
Secondary
Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset.
Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-16 assay cut-off value was defined as greater than or equal to 8 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 8 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region
Time frame: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- before vaccination | 0 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 7 | 406 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 12 | 384 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 18 | 377 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 24 | 392 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 36 | 361 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 48 | 345 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 60 | 275 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 72 | 276 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 84 | 273 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ before vaccination | 170 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 7 | 170 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 12 | 154 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 24 | 158 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 18 | 147 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 36 | 137 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 48 | 132 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 60 | 99 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 72 | 99 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 84 | 95 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 60 | 79 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- before vaccination | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ before vaccination | 179 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 7 | 13 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 36 | 131 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 12 | 28 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 7 | 166 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 18 | 9 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 84 | 51 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 24 | 11 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 12 | 151 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 36 | 23 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 48 | 135 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 48 | 31 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 24 | 144 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 60 | 11 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 72 | 57 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 72 | 5 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero+ at Month 18 | 136 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-16 in the Immunogenicity Subset. | Sero- at Month 84 | 2 Participants |
Secondary
Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset.
Seroconversion was defined as the appearance of antibodies (i.e.; titre greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. HPV-18 assay cut-off value was defined as greater than or equal to 7 ELISA units per millilitre (EL.U/mL). Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration equal to or above 7 EL.U/mL prior to vaccination. Immuno subset=subjects from selected sites N≥1000, at least 250 per region
Time frame: At pre-vaccination and at Month 7, 12, 18, 24, 36, 48, 60, 72 and 84
Population: The According-To-Protocol cohort for immunogenicity included subjects for whom immunogenicity data were available and for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. The 15% subset of women enrolled with prior history of HPV disease/infection was included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- before vaccination | 0 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 7 | 405 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 12 | 375 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 18 | 366 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 24 | 387 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 36 | 346 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 48 | 336 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 60 | 266 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 72 | 261 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at month 84 | 257 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ before vaccination | 163 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 24 | 153 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 7 | 163 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 12 | 154 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 18 | 149 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 36 | 142 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 48 | 133 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 60 | 101 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 72 | 103 Participants |
| Cervarix Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 84 | 98 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 60 | 58 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- before vaccination | 0 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 36 | 92 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 7 | 12 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ before vaccination | 164 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 12 | 16 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 24 | 114 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 18 | 12 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 84 | 32 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 24 | 14 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 7 | 146 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 36 | 14 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 48 | 94 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 48 | 16 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 12 | 133 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 60 | 11 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 72 | 32 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at Month 72 | 3 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero+ at Month 18 | 118 Participants |
| Aluminium Hydroxide Group | Number of Seroconverted Subjects Against HPV-18 in the Immunogenicity Subset. | Sero- at month 84 | 3 Participants |
Secondary
Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study.
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. Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study. | 28 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any AE/SAE Leading to Premature Discontinuation of the Study. | 14 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any redness | 1058 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any swelling | 1080 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 pain | 303 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 swelling | 97 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 redness | 44 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any pain | 2411 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 redness | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 pain | 73 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any redness | 530 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any pain | 1862 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any swelling | 428 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 swelling | 11 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. A related SAE was defined as an event assessed by the investigator as causally related to the study vaccination.
Time frame: Up to Month 48 and up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related SAEs, M48 | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related SAEs, M84 | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Any SAEs, M84 | 291 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Any SAEs, M48 | 286 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related SAEs, M48 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Any SAEs, M48 | 266 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Any SAEs, M84 | 269 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related SAEs, M84 | 8 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (Fever = axillary temperature above 37.5 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature above 39.0°C.
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 headache | 76 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 fever | 17 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related headache | 666 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any myalgia | 878 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 fatigue | 78 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 myalgia | 46 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related fever | 181 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related myalgia | 541 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade3 arthralgia | 30 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any rash | 185 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any gastrointestinal | 664 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related fatigue | 678 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related rash | 88 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any fatigue | 1116 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any urticaria | 258 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related gastrointestinal | 335 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 urticaria | 21 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any fever | 308 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related urticaria | 84 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any headache | 1165 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 gastrointestinal | 60 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related arthralgia | 323 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 rash | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any arthralgia | 580 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related urticaria | 79 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade3 arthralgia | 24 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related arthralgia | 225 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any fatigue | 916 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 fatigue | 53 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related fatigue | 545 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any fever | 248 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 fever | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related fever | 159 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any gastrointestinal | 592 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 gastrointestinal | 54 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related gastrointestinal | 312 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any headache | 1074 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 headache | 72 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any myalgia | 622 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 myalgia | 32 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related myalgia | 391 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any rash | 124 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 rash | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related rash | 61 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any urticaria | 201 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 urticaria | 18 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any arthralgia | 439 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related headache | 598 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 unsolicited AE = an event that prevented normal activity. A related AE = event assessed by the investigator as causally related to the study vaccination.
Time frame: Within 30 days (Days 0 - 29) post-vaccination period.
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 1153 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 208 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 246 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any AEs | 1164 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 AEs | 184 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related AEs | 191 Participants |
Secondary
Number of Subjects Reporting Medically Significant Conditions (MAEs).
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Medically Significant Conditions (MAEs). | 1170 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Medically Significant Conditions (MAEs). | 1140 Participants |
Secondary
Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs).
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs). | 24 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting New Onset of Autoimmune Disease (NOADs). | 24 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Disease (NOCDs).
NOCDs include autoimmune disorders, asthma and type I diabetes.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Disease (NOCDs). | 143 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting New Onset of Chronic Disease (NOCDs). | 165 Participants |
Secondary
Number of Subjects Reporting Related or Fatal Serious Adverse Event.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Fatal AEs | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Related SAEs | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Fatal AEs | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects Reporting Related or Fatal Serious Adverse Event. | Related SAEs | 8 Participants |
Secondary
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, DNA- and sero- subjects | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16, DNA- and sero- subjects | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18, DNA- and sero- subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, overall | 6 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16 | 5 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18 | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16 | 38 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, DNA- and sero- subjects | 47 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, overall | 56 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16, DNA- and sero- subjects | 34 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18 | 19 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18, DNA- and sero- subjects | 14 Participants |
Secondary
Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Results for seropositive status were not analysed.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, DNA- and sero- subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16, DNA- and sero- subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18, DNA- and sero- subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, overall | 5 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16 | 4 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18 | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16 | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, DNA- and sero- subjects | 31 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16/18, overall | 38 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-16, DNA- and sero- subjects | 24 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18 | 12 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Any Cytological Abnormalities Associated With HPV-16 or HPV-18 Cervical Infection | HPV-18, DNA- and sero- subjects | 8 Participants |
Secondary
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-16 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-18 | 1 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-33 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-35 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39 | 10 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-45 | 3 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-51 | 21 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-52 | 19 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-56 | 9 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-58 | 12 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-59 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-66 | 13 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-68 | 8 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45 | 7 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58 | 40 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39/45/59/68 | 24 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/33/35/52/58 | 41 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58/35/39/51/56/59 | 79 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HRW | 94 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HR | 96 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-58 | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-16 | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58/35/39/51/56/59 | 107 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-18 | 12 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-59 | 15 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31 | 12 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39/45/59/68 | 48 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-33 | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-66 | 26 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-35 | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HR | 148 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39 | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-68 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-45 | 17 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/33/35/52/58 | 49 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-51 | 18 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45 | 28 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-52 | 19 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HRW | 126 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-56 | 19 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58 | 54 Participants |
Secondary
Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects who were HPV DNA negative for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HRW-HPV= All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR= High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-59 | 9 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-35 | 7 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-66 | 22 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-51 | 38 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-68 | 15 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-16 | 5 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45 | 10 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-18 | 1 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58 | 56 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-52 | 25 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39/45/59/68 | 49 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39 | 21 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/33/35/52/58 | 56 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-56 | 15 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58/35/39/51/56/59 | 119 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31 | 5 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HRW | 143 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-58 | 19 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HR | 145 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-45 | 5 Participants |
| Cervarix Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-33 | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-68 | 15 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-16 | 38 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-18 | 19 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31 | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-33 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-35 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39 | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-45 | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-51 | 34 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-52 | 22 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-56 | 28 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-58 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-59 | 22 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-66 | 43 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45 | 44 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58 | 78 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-39/45/59/68 | 74 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/33/35/52/58 | 70 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-31/45/33/52/58/35/39/51/56/59 | 160 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HRW | 192 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Cytological Abnormalities Associated With Oncogenic HPV Types Individually or in Combinations | HPV-HR | 223 Participants |
Secondary
Number of Subjects With First Colposcopy
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With First Colposcopy | 392 Participants |
| Aluminium Hydroxide Group | Number of Subjects With First Colposcopy | 422 Participants |
Secondary
Number of Subjects With First Colposcopy
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With First Colposcopy | 506 Participants |
| Aluminium Hydroxide Group | Number of Subjects With First Colposcopy | 560 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA)
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. TAA: Type assignment algorithm. The lesion was assigned to an HPV type found in the lesion if 1. the same HPV type was found in at least one of the two (closest) preceding cytology samples, or 2. none of the HPV types found in the lesion were found in any of the two preceding cytology samples (isolate HPV types)
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | HPV-16/18 DNA- | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | HPV-16 DNA- | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | HPV-18 DNA- | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | HPV-16/18 DNA- | 9 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | HPV-16 DNA- | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the Type Assignment Algorithm (TAA) | HPV-18 DNA- | 5 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 12 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 9 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero+ subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero+ subjects | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero+ subjects | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 16 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 10 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-/+: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 0 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero+ subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero+ subjects | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero+ subjects | 2 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 | 35 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 | 24 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 | 56 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 | 42 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 | 20 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 | 26 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 | 37 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 | 14 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 | 66 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 | 49 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 | 23 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | 152 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | 178 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status
CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | 179 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Irrespective of HPV Cervical Infection and Irrespective of Baseline HPV DNA Status | 229 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: * DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 0 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 2 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done in: - DNA- and sero-: subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline. Note: Results for seropositive status were not analysed.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, overall | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, DNA- and sero- subjects | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18, overall | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16, DNA- and sero- subjects | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, overall | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18, DNA- and sero- subjects | 2 Participants |
Secondary
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | 76 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | 84 Participants |
Secondary
Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy
Detection was done on all subjects irrespective of their baseline HPV DNA status.
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | 88 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Histopathologically Confirmed Reduction of Local Cervical Therapy | 110 Participants |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 18 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 12 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 21 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 14 Participants |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as the detection of the same HPV type(s) PCR in cervical samples at all available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 0 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 37 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 30 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 43 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 13 Participants |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Persistent HPV infection (12-month definition) = detection of the same HPV type(s) by PCR in cervical samples at available time points over approximately a 12-month interval (evaluations are planned at approximately 6-month intervals). Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 21 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 10 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 39 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 27 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 38 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 70 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 86 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 88 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 14 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 84 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 29 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 122 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 5 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 51 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 14 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 17 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 105 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 49 Participants |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. subjects HPV DNA- for the corresponding HPV type at Month 0 6, regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 , 68
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 22 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 13 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 14 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 23 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 65 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 46 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 34 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 64 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 118 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 145 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 20 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 147 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 14 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 16 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 30 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 17 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 9 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 26 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 31 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 15 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 10 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 22 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 28 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 75 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 54 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 72 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 129 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 160 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (12-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 194 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18 | 92 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16 | 65 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18 | 30 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16 | 151 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18 | 68 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18 | 206 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA).
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus. The lesion was assigned to an HPV type found in the lesion if (1) the same HPV type was found in at least 1 of the 2 (closest) preceding cytology samples, or (2) none of the HPV types found in the lesion were found in any of the 2 preceding cytology samples (isolate HPV types)
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18 | 89 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16 | 63 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18 | 29 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16/18 | 155 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-16 | 117 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 or HPV-18 and/or With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or -18 Cervical Infection Detected Using the HPV Type Assignment Algorithm (TAA). | HPV-18 | 49 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: - DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). - Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 4 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 67 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 51 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 82 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 17 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 60 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 9 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Detection was done in: * DNA- and sero-/+: subjects HPV DNA negative (DNA-) at Month 0 and Month 6 for the corresponding HPV-type and seronegative/positive (sero-/+) for HPV-16 and/or HPV-18 by ELISA at baseline (Month 0). * Overall: subjects DNA- at Month 0 and Month 6 for the corresponding HPV-type and regardless of initial serostatus at baseline.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero+ subjects | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero- subjects | 34 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, overall | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, DNA- and sero- subjects | 26 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero+ subjects | 3 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-18, DNA- and sero- subjects | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16, overall | 34 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, DNA- and sero+ subjects | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 | HPV-16/18, overall | 45 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16/18 | 90 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16 | 64 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-18 | 30 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16/18 | 158 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16 | 118 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-18 | 52 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection
Persistent cervical HPV infection (6-month definition) was defined as the detection of the same HPV type(s) by polymerase chain reaction (PCR) in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. CIN1+ was defined as CIN grades 1, 2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Detection was done on all subjects irrespective of their baseline HPV DNA and serostatus.
Time frame: Up to Month 84
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16/18 | 93 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16 | 66 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-18 | 32 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16/18 | 209 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-16 | 152 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Human Papillomavirus (HPV)-16 or HPV-18 and/or With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 and/or -18 Cervical Infection | HPV-18 | 71 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: Up to Month 84
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 255 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 24 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 262 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 98 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 28 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 92 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 10 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 31 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 101 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 22 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 34 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 206 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 19 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 48 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 54 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 45 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 30 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 56 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 30 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 19 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 21 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 49 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 33 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 57 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 128 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 102 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 118 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 220 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 274 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 330 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 60 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 29 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 9 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 17 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 26 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 42 Participants |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations.
Persistent cervical HPV infection (6-month definition) = detection of the same HPV type(s) by PCR in cervical samples at 2 consecutive evaluations over approximately a 6-month interval. Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Detection was done in subjects HPV DNA- for the corresponding HPV type at baseline (at month 0 and Month 6) regardless of initial serostatus. HPV-HRW=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18. HPV-HR=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: Up to Month 48
Population: The According-To-Protocol cohort for efficacy included subjects who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0, who received 3 doses. A 15% subset of women enrolled with prior history of HPV infection was excluded.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 15 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 58 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 50 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 63 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 132 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 163 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 170 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 20 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 27 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 33 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 16 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31 | 19 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-68 | 23 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-58 | 8 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45 | 35 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-33 | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58 | 83 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-52 | 38 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39/45/59/68 | 60 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-35 | 13 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/33/35/52/58 | 80 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-66 | 27 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-31/45/33/52/58/35/39/51/56/59 | 146 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-39 | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HRW | 185 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-56 | 20 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-HR | 217 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-45 | 17 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-16 | 34 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-59 | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-18 | 11 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Persistent Infection (6-month Definition) With Oncogenic HPV Types Individually or in Combinations. | HPV-51 | 26 Participants |
Secondary
Number of Subjects With Pregnancies and Their Outcomes.
Pregnancy outcomes are live infant, premature live infant, elective termination, ectopic pregnancy, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
Time frame: Up to Month 48
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Live infant No ACA, M48 | 259 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Live infant CA, M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Elective termination No ACA, M48 | 19 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Elective termination CA, M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Ectopic pregnancy, M48 | 5 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Spontaneous abortion No ACA, M48 | 69 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Spontaneous abortion CA, M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Stillbirth No ACA, M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes. | Lost to follow-up, M48 | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Stillbirth No ACA, M48 | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Spontaneous abortion CA, M48 | 1 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Live infant No ACA, M48 | 249 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Ectopic pregnancy, M48 | 6 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Live infant CA, M48 | 7 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Lost to follow-up, M48 | 2 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Elective termination No ACA, M48 | 24 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Spontaneous abortion No ACA, M48 | 66 Participants |
| Aluminium Hydroxide Group | Number of Subjects With Pregnancies and Their Outcomes. | Elective termination CA, M48 | 0 Participants |