Infections, Papillomavirus
Conditions
Brief summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary & follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.
Interventions
PROCEDUREBlood sampling
Blood sampling at Visit 3, 5 and 7.
PROCEDURECollection of cervical specimen
Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.
BIOLOGICALCervarix
Three doses administered intramuscularly at 0, 1 and 6 months.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * Subjects who participated in study 580299-007. * Written informed consent obtained from the subject prior to enrollment.
Exclusion criteria
* Use or planned use of any investigational or non-registered product other than the study vaccine. * Decoding of the subject's 580299-001 treatment allocation to either the subject or the investigator. * Administration or planned administration of any other HPV vaccine, other than the vaccine administered in study 580299-001.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | Up to year 8 | Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type. |
| Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | Up to year 7 | Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | Up to year 8 | Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types | Up to year 8 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | Up to year 8 | Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | Up to year 8 | Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | Up to year 8 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Up to year 8 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | Up to year 8 | Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 8 | CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 8 | CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 8 | CIN1+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 8 | CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 8 | CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 8 | CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | Up to year 8 | Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Up to year 8 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | Up to year 8 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Up to year 8 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | Up to year 8 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | At Months 77-101 | Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL). |
| Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | At Months 77-101 | Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum |
| Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7 | Up to year 7 | NOCDs include for example asthma, type I diabetes, allergies, ... |
| Number of Subjects With NOCD up to Year 8 | Up to year 8 | NOCDs included for example asthma, type I diabetes, allergies, ... NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available. |
| Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7 | Up to year 7 | — |
| Number of Subjects With NOAD up to Year 8 | Up to year 8 | The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available. |
| Number of Subjects With Medically Significant Conditions up to Year 7 | Up to year 7 | Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Medically significant conditions which were not unblinded at the time of the analysis are not presented yet. |
| Number of Subjects With Medically Significant Conditions up to Year 8 | up to year 8 | Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Medically significant conditions which were not unblinded at the time of the analysis are not presented yet. |
| Number of Subjects With Serious Adverse Events (SAEs) up to Year 7 | Up to year 7 | SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject |
| Number of Subjects With SAEs up to Year 8 | up to year 8 | SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject |
| Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Up to year 9 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Up to year 9 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | Up to year 9 | Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | Up to year 9 | Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Up to year 9 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study. |
| Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | Up to year 9 | Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study |
| Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Up to year 9 | NOCDs include for example asthma, type I diabetes, allergies, ... |
| Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Up to year 9 | — |
| Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type | Up to year 8 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Serious Adverse Events (SAEs) up to Year 9. | up to year 9 | SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject |
| Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | Up to year 7 | Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type | Up to year 7 | Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study. |
| Number of Subjects With Medically Signifant Conditions up to Year 9 | Up to year 9 | Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | Up to year 8 | Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study. |
Countries
Brazil
Participant flow
Pre-assignment details
Out of the five subjects withdraw at Year 7, three subjects came back during Year 8 and are therefore not longer considered as withdraw subjects. At Year 9, one subject, who did not participate to Year 7 and Year 8 visits, came back for one of the visits and was added to Total cohort.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study. | 222 |
| Placebo Group Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study. | 211 |
| Total | 433 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Year 7 | Could not attend in time | 0 | 3 |
| Year 7 | Lost to Follow-up | 2 | 0 |
| Year 8 | Could not attend in time | 0 | 1 |
| Year 8 | Lost to Follow-up | 1 | 1 |
| Year 9 | Lost to Follow-up | 3 | 0 |
| Year 9 | Migrated/moved from study area | 1 | 1 |
| Year 9 | Personal reasons | 1 | 0 |
Baseline characteristics
| Characteristic | Cervarix Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 26.5 years STANDARD_DEVIATION 3.2 | 26.4 years STANDARD_DEVIATION 2.9 | 26.5 years STANDARD_DEVIATION 3.05 |
| Gender Female | 222 Participants | 211 Participants | 433 Participants |
| Gender 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 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 20 / 224 | 11 / 213 |
Outcome results
Primary
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
Time frame: Up to year 7
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | HPV-16 (N=171;128) | 0 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | HPV-18 (N=169;133) | 0 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | HPV-16/18 (N=169;117) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | HPV-16 (N=171;128) | 2 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | HPV-18 (N=169;133) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and /or HPV-18 | HPV-16/18 (N=169;117) | 2 Subjects |
Primary
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type.
Time frame: Up to year 8
Population: According-To-Protocol (ATP) cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16 (N=176;122) | 0 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-18 (N=178;133) | 0 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16/18 (N=176;139) | 0 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16 (N=176;122) | 5 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-18 (N=178;133) | 4 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16/18 (N=176;139) | 5 subjects |
Primary
Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18
Cervical HPV infection was defined as the first detection of an HPV type in a subject previously negative for that HPV type
Time frame: Up to year 9
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16 (N=179;133) | 0 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-18 (N=177;140) | 0 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16/18 (N=177;122) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16 (N=179;133) | 9 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-18 (N=177;140) | 6 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Human Papillomavirus (HPV) -16 and/or HPV-18 | HPV-16/18 (N=177;122) | 9 Subjects |
Secondary
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Titers are given as Geometric Mean Titers (GMTs) expressed as ELISA Units per milliliter (EL.U/mL).
Time frame: At Months 77-101
Population: The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 77-82 (N= 69; 54) | 374.9 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 83-88 (N= 111; 68) | 383.4 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 89-94 (N= 94; 67) | 346.3 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 95-101 (N= 87; 56) | 435.1 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 77-82 (N= 69; 54) | 252.8 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 83-88 (N= 111; 68) | 251.0 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 89-94 (N= 94; 67) | 234.6 EL.U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 95-101 (N= 87; 56) | 246.5 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 95-101 (N= 87; 56) | 4.6 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 77-82 (N= 69; 54) | 5.4 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 77-82 (N= 69; 54) | 4.3 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 83-88 (N= 111; 68) | 5.1 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 89-94 (N= 94; 67) | 4.4 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 89-94 (N= 94; 67) | 5.4 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 83-88 (N= 111; 68) | 5.0 EL.U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 95-101 (N= 87; 56) | 5.4 EL.U/mL |
Secondary
Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked immunosorbent assay (ELISA) Units per milliliter (EL.U/mL). The cut-off-vales assessed were \>= 8 or 7 EL. U/mL for anti-HPV-16 and 18, respectively.
Time frame: At Month 77 until year 9 (Month 113)
Population: The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 77-82 (N=69;52) | 374.9 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 83-88 (N=111;65) | 383.4 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 89-94 (N=94;65) | 346.3 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 95-100 (N=87;53) | 435.1 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 101-106 (N=87;63) | 322.8 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 107-113 (N=92;60) | 418.3 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 77-82 (N=69;52) | 252.8 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 83-88 (N=111;65) | 251.0 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 89-94 (N=94;65) | 234.6 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 95-100 (N=87;53) | 246.5 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anto-HPV-18 Month 101-106 (N=87;63) | 225.0 EL. U/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 107-113 (N=92;60) | 242.6 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anto-HPV-18 Month 101-106 (N=87;63) | 4.1 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 77-82 (N=69;52) | 5.2 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 77-82 (N=69;52) | 4.2 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 83-88 (N=111;65) | 5.2 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 95-100 (N=87;53) | 4.6 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 89-94 (N=94;65) | 5.4 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 83-88 (N=111;65) | 5.0 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 95-100 (N=87;53) | 5.4 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 107-113 (N=92;60) | 4.8 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 101-106 (N=87;63) | 5.2 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-18 Month 89-94 (N=94;65) | 4.4 EL. U/mL |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Enzyme-linked Immunosorbent Assay (ELISA) Titers in the Immunogenicity Cohort | Anti-HPV-16 Month 107-113 (N=92;60) | 6.1 EL. U/mL |
Secondary
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Time frame: At Month 77 until year 9 (Month 113)
Population: The analyses were performed on the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 77-82 (N=15;4) | 1616.1 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 83-88 (N=30;8) | 1990.7 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 89-94 (N=18;6) | 1385.0 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 95-101 (N=27;6) | 1611.6 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 101-106 (N=16;7) | 1380.7 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 107-113 (N=30;5) | 1549.8 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 77-82 (N=15;4) | 845.4 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 83-88 (N=30;8) | 751.6 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 89-94 (N=18;6) | 1185.3 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 95-101 (N=27;6) | 578.2 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 101-106 (N=16;7) | 860.1 Titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 107-113 (N=30;5) | 552.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 101-106 (N=16;7) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 77-82 (N=15;4) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 77-82 (N=15;4) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 83-88 (N=30;8) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 95-101 (N=27;6) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 89-94 (N=18;6) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 83-88 (N=30;8) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 95-101 (N=27;6) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 107-113 (N=30;5) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 101-106 (N=16;7) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 89-94 (N=18;6) | 20.0 Titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 107-113 (N=30;5) | 20.0 Titer |
Secondary
Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum
Time frame: At Months 77-101
Population: The analyses were performed on a subset of the ATP cohort for immunogenicity, which included evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 95-101 (N= 27; 6) | 1611.6 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 77-82 (N= 15; 4) | 1616.1 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 83-88 (N= 30; 8) | 1990.7 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 89-94 (N= 18; 6) | 1385.0 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 77-82 (N= 15; 4) | 845.4 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 83-88 (N= 30; 8) | 751.6 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 89-94 (N= 18; 6) | 1185.3 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 95-101 (N= 27; 6) | 578.2 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 95-101 (N= 27; 6) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 77-82 (N= 15; 4) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 77-82 (N= 15; 4) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 89-94 (N= 18; 6) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 83-88 (N= 30; 8) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-18 Month 83-88 (N= 30; 8) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 89-94 (N= 18; 6) | 20.0 titer |
| Placebo Group | Anti-HPV-16 and Anti-HPV-18 Pseudovirion-based Neutralization Assay (PBNA) Titers in the Immunogenicity Subset | Anti-HPV-16 Month 95-101 (N= 27; 6) | 20.0 titer |
Secondary
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=154; 133) | 32 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=154; 135) | 32 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=154; 133) | 39 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=154; 135) | 36 subjects |
Secondary
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 9
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Including HPV-16 or 18 (N=155;135) | 38 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Without HPV-16 or 18 (N=155;136) | 38 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Including HPV-16 or 18 (N=155;135) | 49 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Without HPV-16 or 18 (N=155;136) | 45 Subjects |
Secondary
Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type.
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Including HPV-16 or 18 (N=148;122) | 22 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Without HPV-16 or 18 (N=148;126) | 22 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Including HPV-16 or 18 (N=148;122) | 16 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Any Oncogenic HPV Type. | Without HPV-16 or 18 (N=148;126) | 14 Subjects |
Secondary
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 9
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-31 (N=197;170) | 4 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-33 (N=197;177) | 2 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-35 (N=197;179) | 4 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-39 (N=191;163) | 5 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-45 (N=203;176) | 3 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-51 (N=167;154) | 11 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-52 (N=172;153) | 18 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-56 (N=182;170) | 3 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-58 (N=191;175) | 7 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-59 (N=195;182) | 2 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-66 (N=176;165) | 4 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-68 (N=188;166) | 8 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-66 (N=176;165) | 10 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-31 (N=197;170) | 5 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-52 (N=172;153) | 10 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-33 (N=197;177) | 4 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-59 (N=195;182) | 2 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-35 (N=197;179) | 9 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-56 (N=182;170) | 4 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-39 (N=191;163) | 3 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-68 (N=188;166) | 9 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-45 (N=203;176) | 5 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-58 (N=191;175) | 3 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-51 (N=167;154) | 15 Subjects |
Secondary
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-31 (N=195; 168) | 1 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-51 (N=166; 152) | 4 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-35 (N=195; 177) | 4 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-52 (N=170; 152) | 15 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-68 (N= 186; 166) | 6 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-56 (N=181; 168) | 2 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-39 (N=189; 162) | 4 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-58 (N=189; 173) | 4 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-33 (N=195; 175) | 0 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-59 (N=193; 180) | 2 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-66 (N= 176; 164) | 3 subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-45 (N=201; 174) | 3 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-68 (N= 186; 166) | 6 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-66 (N= 176; 164) | 8 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-31 (N=195; 168) | 5 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-33 (N=195; 175) | 1 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-35 (N=195; 177) | 5 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-39 (N=189; 162) | 2 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-45 (N=201; 174) | 5 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-51 (N=166; 152) | 10 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-52 (N=170; 152) | 9 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-56 (N=181; 168) | 4 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-58 (N=189; 173) | 2 subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type | HPV-59 (N=193; 180) | 1 subjects |
Secondary
Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type.
Oncogenic types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-31 (N=187;162) | 1 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-33 (N=187;168) | 0 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-35 (N=187;170) | 3 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-39 (N=181;156) | 2 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-45 (N=193;167) | 2 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-51 (N=158;146) | 2 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-52 (N=162;147) | 10 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-56 (N=174;162) | 0 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-58 (N=182;166) | 2 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-59 (N=186;174) | 1 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-66 (N=169;157) | 3 Subjects |
| Cervarix Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-68 (N=179;159) | 4 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-66 (N=169;157) | 3 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-31 (N=187;162) | 1 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-52 (N=162;147) | 3 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-33 (N=187;168) | 1 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-59 (N=186;174) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-35 (N=187;170) | 3 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-56 (N=174;162) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-39 (N=181;156) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-68 (N=179;159) | 2 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-45 (N=193;167) | 3 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-58 (N=182;166) | 0 Subjects |
| Placebo Group | Number of Subjects Presenting Cervical Infections With Individual Oncogenic Non-vaccine HPV Type. | HPV-51 (N=158;146) | 3 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=199;165) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=199;171) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=200;178) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=199;165) | 3 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=199;171) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=200;178) | 2 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N=219;202) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=220;204) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=219;204) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=219;198) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=222;206) | 2 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=203;196) | 3 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=207;184) | 5 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N=208;204) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=215;201) | 3 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=218;208) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=214;195) | 2 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=219;202) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=214;195) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N=219;202) | 5 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=207;184) | 5 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=220;204) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=218;208) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=219;204) | 3 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N=208;204) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=219;198) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=219;202) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=222;206) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=215;201) | 4 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=203;196) | 7 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=197;184) | 15 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=197;185) | 15 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=197;185) | 25 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undertermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=197;184) | 25 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=190;158) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=190;164) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=191;169) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=190;158) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=190;164) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=191;169) | 0 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection
Abnormal cytology included atypical squamus cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical glandular cells (AGC), atypical squamus cells and cannot exclude HSIL (ASC-H). Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N= 198; 165) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N= 198; 171) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N= 199; 177) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N= 198; 165) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N= 198; 171) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N= 199; 177) | 1 subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N=209;192) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=210;194) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=209;194) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=209;189) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=212;196) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=194;187) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=197;176) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N=200;194) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=206;191) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=209;198) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=206;186) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=210;194) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=206;186) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N=209;192) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=197;176) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=210;194) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=209;198) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=209;194) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N=200;194) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=209;189) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=210;194) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=212;196) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=206;191) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=194;187) | 1 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N= 217; 200) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N= 218; 202) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N= 217; 202) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N= 217; 197) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N= 220; 204) | 2 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N= 202; 194) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N= 205; 183) | 3 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N= 207; 202) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N= 213; 199) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N= 216; 206) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N= 214; 194) | 2 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N= 217; 202) | 2 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N= 214; 194) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N= 217; 200) | 5 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N= 205; 183) | 3 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N= 218; 202) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N= 216; 206) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N= 217; 202) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N= 207; 202) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N= 217; 197) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N= 217; 202) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N= 220; 204) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N= 213; 199) | 3 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N= 202; 194) | 3 subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=188;175) | 3 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=188;176) | 3 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=188;175) | 8 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=188;176) | 8 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N= 196; 183) | 10 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N= 196; 184) | 10 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N= 196; 183) | 15 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Atypical Squamous Cells of Undetermined Significance (ASC-US) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N= 196; 184) | 15 subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N= 198; 174) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N= 198; 177) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N= 199; 183) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N= 198; 174) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N= 198; 177) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N= 199; 183) | 1 subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=190;167) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=190;170) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=191;175) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=190;167) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=190;170) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=191;175) | 0 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=199;174) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=199;177) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=200;184) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16/18 (N=199;174) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-16 (N=199;177) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With an HPV 16 and/or HPV-18 Cervical Infection | HPV-18 (N=200;184) | 1 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N=210;194) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=211;197) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=209;196) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=211;192) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=212;197) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=203;190) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=202;184) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (204;194) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=209;195) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=212;199) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=209;187) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=211;198) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=209;187) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N=210;194) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=202;184) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=211;197) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=212;199) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=209;196) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (204;194) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=211;192) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=211;198) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=212;197) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=209;195) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=203;190) | 1 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N= 218; 202) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N= 219; 205) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N= 217; 204) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N= 219; 200) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N= 220; 205) | 2 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N= 211; 197) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N= 210; 191) | 2 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N= 211; 202) | 1 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N= 216; 203) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N= 219; 207) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N= 217; 195) | 0 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N= 219; 206) | 2 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N= 217; 195) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-31 (N= 218; 202) | 4 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N= 210; 191) | 3 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N= 219; 205) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N= 219; 207) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N= 217; 204) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N= 211; 202) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N= 219; 200) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N= 219; 206) | 1 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N= 220; 205) | 0 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N= 216; 203) | 2 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N= 211; 197) | 3 subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC and ASC-H. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-031 (N=220;204) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=221;207) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=219;206) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=221;201) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=222;207) | 2 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=212;199) | 2 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=212;192) | 4 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N=212;204) | 1 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=218;205) | 2 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=221;209) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=217;196) | 0 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=221;206) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-66 (N=217;196) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-031 (N=220;204) | 5 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-52 (N=212;192) | 5 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-33 (N=221;207) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-59 (N=221;209) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-35 (N=219;206) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-56 (N=212;204) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-39 (N=221;201) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-68 (N=221;206) | 1 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-45 (N=222;207) | 0 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-58 (N=218;205) | 3 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Individual Oncogenic Non-vaccine HPV Types Cervical Infection | HPV-51 (N=212;199) | 5 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=198;187) | 12 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=198;187) | 12 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=198;187) | 19 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=198;187) | 19 Subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 | 7 subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 | 7 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 | 12 subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 | 12 subjects |
Secondary
Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection
Abnormal cytology included ASC-US, LSIL, HSIL, AGC, and ASC-H. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=189;178) | 2 Subjects |
| Cervarix Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=189;178) | 2 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Including HPV-16 or 18 (N=189;178) | 6 Subjects |
| Placebo Group | Number of Subjects With Abnormal Cytology Greater Than or Equal to Low-grade Squamous Intraepithelial Lesion (LSIL) Associated With Oncogenic HPV Types Cervical Infection | Without HPV-16 or 18 (N=189;178) | 6 Subjects |
Secondary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN1+ was defined as CIN (Cervical Intraepithelial Neoplasia) grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N= 199; 182) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N= 199; 183) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N= 199; 186) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N= 199; 182) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N= 199; 183) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N= 199; 186) | 0 subjects |
Secondary
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 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. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N=191;175) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=191;178) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=191;176) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N=191;175) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=191;176) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=191;178) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
Cervical Intraepithelial Neoplasia (CIN1)+ was defined as CIN grades 1,2 and 3, adenocarcinoma in situ (AIS) and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N=200;183) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=200;184) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=200;187) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N=200;183) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=200;184) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=200;187) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types 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. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N= 221; 207) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N= 220; 207) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N= 219; 206) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N= 222; 209) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N= 221; 208) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N= 215; 206) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N= 218; 204) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N= 219; 209) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=221; 206) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=220; 208) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N= 219; 203) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N= 221; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N= 219; 203) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N= 221; 207) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N= 218; 204) | 1 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N= 220; 207) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=220; 208) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N= 219; 206) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N= 219; 209) | 1 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N= 222; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N= 221; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N= 221; 208) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=221; 206) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N= 215; 206) | 0 subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types 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. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=213;199) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=212;199) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=211;198) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=214;201) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=213;200) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=207;198) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=210;196) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=211;201) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=213;198) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=212;200) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=211;195) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=213;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=211;195) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=213;199) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=210;196) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=212;199) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=212;200) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=211;198) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=211;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=214;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=213;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=213;200) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=213;198) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=207;198) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types 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. Oncogenic HPV types assessed included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=223;209) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=222;209) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=221;208) | 1 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=224;211) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=223;210) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=217;208) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=220;206) | 2 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=221;211) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=223;208) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=222;210) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=220;205) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=223;210) | 2 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=220;205) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=223;209) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=220;206) | 2 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=222;209) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=222;210) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=221;208) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=221;211) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=224;211) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=223;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=223;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=223;208) | 2 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=217;208) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types 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. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HRV-16 or 18 | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HRV-16 or 18 | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HRV-16 or 18 | 1 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HRV-16 or 18 | 1 subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types 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. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=200;188) | 3 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=200;188) | 3 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=200;188) | 4 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=200;188) | 4 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types 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. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=191;179) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=191;179) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=191;179) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN1+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=191;179) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N=200;185) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=200;186) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=200;187) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N=200;185) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=200;186) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=200;187) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HVP-16/18 (N=191;176) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=191;177) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=191;178) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HVP-16/18 (N=191;176) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N=191;177) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N=191;178) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N= 199; 184) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N= 199; 185) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N= 199; 186) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16/18 (N= 199; 184) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-16 (N= 199; 185) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 or HPV-18 Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-18 (N= 199; 186) | 0 subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=223;210) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=222;210) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=222;208) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=224;211) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=223;210) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=219;209) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=220;208) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=221;211) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=223;209) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=222;210) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=221;207) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=223;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=221;207) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=223;210) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=220;208) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=222;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=222;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=222;208) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=221;211) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=224;211) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=223;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=223;210) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=223;209) | 2 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=219;209) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=213;200) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=212;200) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=212;198) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=214;201) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=213;200) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=209;199) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=210;198) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=211;201) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=213;199) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=212;200) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=212;197) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=213;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N=212;197) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N=213;200) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N=210;198) | 1 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N=212;200) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N=212;200) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N=212;198) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N=211;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N=214;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N=213;201) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N=213;200) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N=213;199) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N=209;199) | 0 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. and were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N= 220; 208) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N= 218; 206) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N= 222; 209) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N= 219; 209) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N= 221; 208) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N= 221; 207) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N= 221; 208) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N= 220; 208) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N= 220; 206) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N= 220; 205) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N= 217; 207) | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N= 221; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-51 (N= 217; 207) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-31 (N= 221; 208) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-33 (N= 220; 208) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-35 (N= 220; 206) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-39 (N= 222; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-45 (N= 221; 208) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-68 (N= 221; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-52 (N= 218; 206) | 1 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-56 (N= 219; 209) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-58 (N= 221; 207) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-59 (N= 220; 208) | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Individual Oncogenic Non-Vaccine HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | HPV-66 (N= 220; 205) | 0 subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 | 0 subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 | 0 subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 | 0 subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=200;188) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=200;188) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=200;188) | 2 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=200;188) | 2 Subjects |
Secondary
Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen
CIN2+ was defined as CIN grades 2 and 3, AIS and invasive cervical cancer. Oncogenic HPV types assessed included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=191;179) | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=191;179) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Including HPV-16 or 18 (N=191;179) | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically Confirmed CIN2+ Associated With Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen | Without HPV-16 or 18 (N=191;179) | 0 Subjects |
Secondary
Number of Subjects With Medically Signifant Conditions up to Year 9
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Tendonitis | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Medically Signifant Conditions up to Year 9 | 60 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Gastritis | 5 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Hypertension | 5 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Abortion spontaneous incomplete | 5 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Depression | 5 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Nephrolithiasis | 3 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Abortion missed | 2 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Hypothyroidism | 2 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Panic disorder | 2 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Bursitis | 2 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Ovarian cyst | 2 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Ovarian disorder | 2 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Anaemia | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Gynaecological chlamydia infection | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pneumonia | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pyelonephritis | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Blood pressure increased | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Bipolar disorder | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Genital herpes | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Haemorrhoids | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Peptic ulcer | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Vomiting | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Chest pain | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Cholelithiasis | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Breast infection | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Dengue fever | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Erysipelas | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Gingival abscess | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pelvic inflammatory disease | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Staphylococcal infection | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Toxoplasmosis | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Abnormal loss of weight | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Metabolic syndrome | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Cervical spinal stenosis | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Synovial cyst | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Benign breast neoplasm | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Benign hydatidiform mole | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Ovarian cancer | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Headache | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Blighted ovum | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Intra-uterine death | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Oligohydramnios | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pre-eclampsia | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Rhinitis allergic | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Dermatitis allergic | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Sexual abuse | 0 Subjects |
| Cervarix Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Haematoma | 0 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Sexual abuse | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Breast infection | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Medically Signifant Conditions up to Year 9 | 38 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Benign breast neoplasm | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Gastritis | 2 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Dengue fever | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Hypertension | 2 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Oligohydramnios | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Erysipelas | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Depression | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Benign hydatidiform mole | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Nephrolithiasis | 0 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Gingival abscess | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Abortion missed | 2 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Dermatitis allergic | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Hypothyroidism | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pelvic inflammatory disease | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Panic disorder | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Ovarian cancer | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Bursitis | 0 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Staphylococcal infection | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Ovarian cyst | 0 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Intra-uterine death | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Ovarian disorder | 0 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pre-eclampsia | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Anaemia | 2 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Toxoplasmosis | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Gynaecological chlamydia infection | 2 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Headache | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pneumonia | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Abnormal loss of weight | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Pyelonephritis | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Haematoma | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Blood pressure increased | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Metabolic syndrome | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Bipolar disorder | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Blighted ovum | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Genital herpes | 3 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Cervical spinal stenosis | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Haemorrhoids | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Rhinitis allergic | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Peptic ulcer | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Synovial cyst | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Vomiting | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Abortion spontaneous incomplete | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Chest pain | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Tendonitis | 1 Subjects |
| Placebo Group | Number of Subjects With Medically Signifant Conditions up to Year 9 | Cholelithiasis | 1 Subjects |
Secondary
Number of Subjects With Medically Significant Conditions up to Year 7
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Medically significant conditions which were not unblinded at the time of the analysis are not presented yet.
Time frame: Up to year 7
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions up to Year 7 | 18 subjects |
| Placebo Group | Number of Subjects With Medically Significant Conditions up to Year 7 | 13 subjects |
Secondary
Number of Subjects With Medically Significant Conditions up to Year 8
Medically significant conditions include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. Medically significant conditions which were not unblinded at the time of the analysis are not presented yet.
Time frame: up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions up to Year 8 | 40 subjects |
| Placebo Group | Number of Subjects With Medically Significant Conditions up to Year 8 | 24 subjects |
Secondary
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7
Time frame: Up to year 7
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7 | 0 subjects |
| Placebo Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 7 | 0 subjects |
Secondary
Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9.
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Number of Subjects With NOAD up to Year 9 | 4 Subjects |
| Cervarix Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Rheumatoid arthritis | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Vitiligo | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Hypothyroidism | 2 Subjects |
| Placebo Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Hypothyroidism | 1 Subjects |
| Placebo Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Number of Subjects With NOAD up to Year 9 | 1 Subjects |
| Placebo Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Vitiligo | 0 Subjects |
| Placebo Group | Number of Subjects With New Onset Autoimmune Disease (NOAD) up to Year 9. | Rheumatoid arthritis | 0 Subjects |
Secondary
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7
NOCDs include for example asthma, type I diabetes, allergies, ...
Time frame: Up to year 7
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7 | 0 subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 7 | 0 subjects |
Secondary
Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9
NOCDs include for example asthma, type I diabetes, allergies, ...
Time frame: Up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Number of Subjects With NOCD up to Year 9 | 6 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Hypothyroidism | 2 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Drug hypersensitivity | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Rhinitis allergic | 0 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Type 2 diabetes mellitus | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Rheumatoid arthritis | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Dermatitis allergic | 0 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Skin reaction | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Vitiligo | 1 Subjects |
| Cervarix Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Hypertension | 1 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Skin reaction | 0 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Number of Subjects With NOCD up to Year 9 | 3 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Rheumatoid arthritis | 0 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Hypothyroidism | 1 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Hypertension | 0 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Drug hypersensitivity | 0 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Dermatitis allergic | 1 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Rhinitis allergic | 1 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Vitiligo | 0 Subjects |
| Placebo Group | Number of Subjects With New Onset Chronic Diseases (NOCD) up to Year 9 | Type 2 diabetes mellitus | 0 Subjects |
Secondary
Number of Subjects With NOAD up to Year 8
The values of NOADs are not yet corresponding to the values in each group. The cases are still blinded. They will be disclosed as soon as the results will be available.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With NOAD up to Year 8 | 2 subjects |
| Placebo Group | Number of Subjects With NOAD up to Year 8 | 2 subjects |
Secondary
Number of Subjects With NOCD up to Year 8
NOCDs included for example asthma, type I diabetes, allergies, ... NOCDs which were not unblinded at the subject level at the time of the analysis are not presented and will be disclosed as soon as they become available.
Time frame: Up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With NOCD up to Year 8 | 5 subjects |
| Placebo Group | Number of Subjects With NOCD up to Year 8 | 2 subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=158;138) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=158;138) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=158;138) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=158;138) | 0 Subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Including HPV-16 or 18 (N= 163; 142) | 8 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Without HPV-16 or 18 (N= 163; 143) | 8 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Including HPV-16 or 18 (N= 163; 142) | 3 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Without HPV-16 or 18 (N= 163; 143) | 3 subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 9
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Including HPV-16 or 18 (N=164;143) | 13 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Without HPV-16 or 18 (N=164;144) | 13 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Including HPV-16 or 18 (N=164;143) | 10 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Any Oncogenic HPV Types | Without HPV-16 or 18 (N=164;144) | 8 Subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Time frame: Up to year 9
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=179;153) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=179;155) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=179;157) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=179;153) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=179;155) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=179;157) | 2 Subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=171;146) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=171;148) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=171;150) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=171;146) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=171;148) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=171;150) | 0 Subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N= 178; 152) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N= 178; 154) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N= 178; 156) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N= 178; 152) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N= 178; 154) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N= 178; 156) | 0 subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N= 202; 181) | 1 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N= 202; 184) | 1 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N= 200; 185) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV- 39 (N= 200; 179) | 2 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N= 204; 186) | 3 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV- 51 (N= 198; 182) | 1 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N= 191; 172) | 3 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N= 200; 185) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N= 199; 183) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N= 203; 186) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N= 195; 177) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N= 200; 184) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N= 195; 177) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N= 202; 181) | 2 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N= 191; 172) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N= 202; 184) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N= 203; 186) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N= 200; 185) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N= 200; 185) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV- 39 (N= 200; 179) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N= 200; 184) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N= 204; 186) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N= 199; 183) | 1 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV- 51 (N= 198; 182) | 1 subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N=194;174) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=194;177) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=192;178) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=192;173) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=196;179) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=190;175) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=183;166) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=193;178) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=193;178) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=196;179) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=187;170) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=192;177) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=187;170) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N=194;174) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=183;166) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=194;177) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=196;179) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=192;178) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=193;178) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=192;173) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=192;177) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=196;179) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=193;178) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=190;175) | 0 Subjects |
Secondary
Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Individual oncogenic non-vaccine HPV types include HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (12-month definition) was defined as detection of the same HPV type in cervical specimens at all consecutive evaluations over a minimum of 10 months. Subjects with an event did not report the same event in the earlier studies and were DNA negative for the corresponding HPV type at month 6 in the primary study
Time frame: Up to year 9
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=204;186) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=193;174) | 3 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=202;181) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N=204,183) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=201;185) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=206;188) | 4 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=205;188) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=202;187) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=196;179) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=200;184) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=202;185) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=202;187) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=202;185) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N=204,183) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=204;186) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=202;187) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=202;181) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=206;188) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=200;184) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=193;174) | 3 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=202;187) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=201;185) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=205;188) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (12-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=196;179) | 1 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 9
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=163;143) | 20 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=163;144) | 20 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=163;143) | 25 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=163;144) | 24 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 7
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=157;137) | 5 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=157;138) | 5 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Including HPV-16 or 18 (N=157;137) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Type | Without HPV-16 or 18 (N=157;138) | 4 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types
Oncogenic HPV types included HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types | Including HPV-16 or 18 (N=162; 142) | 15 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types | Without HPV-16 or 18 (N=162; 143) | 15 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types | Including HPV-16 or 18 (N=162; 142) | 17 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Any Oncogenic HPV Types | Without HPV-16 or 18 (N=162; 143) | 17 subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Time frame: Up to year 9
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study, who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=179;144) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=179;149) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=179;152) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=179;144) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=179;149) | 3 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=179;152) | 3 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study
Time frame: Up to year 7
Population: The According -To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=171;139) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=171;144) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=171;145) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=171;139) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=171;144) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=171;145) | 0 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18
Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event in the earlier studies. Subjects were DNA negative for the 14 oncogenic HPV types and had a normal cytology at baseline in the primary study. Subjects with an event were DNA negative for the corresponding HPV type at month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=178; 144) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=178; 149) | 0 subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=178;151) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16/18 (N=178; 144) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-16 (N=178; 149) | 0 subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With HPV-16 and/or HPV-18 | HPV-18 (N=178;151) | 0 subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 9
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N=203;182) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=201;184) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=202;182) | 4 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=201;176) | 3 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=205;186) | 4 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=193;176) | 4 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=187;167) | 6 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=198;184) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=197;183) | 5 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=204;186) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=192;172) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=201;182) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=192;172) | 5 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N=203;182) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=187;167) | 7 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=201;184) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=204;186) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=202;182) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=198;184) | 3 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=201;176) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=201;182) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=205;186) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=197;183) | 3 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=193;176) | 4 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 8
Population: The ATP cohort for analysis of efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. who met all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N= 201; 180) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N= 199; 182) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N= 200; 180) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N= 199; 174) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N= 203; 184) | 4 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N= 191; 174) | 3 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N= 185; 166) | 4 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N= 196; 182) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N= 195; 181) | 3 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=202; 184) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N= 191; 171) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N= 199; 181) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N= 191; 171) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N= 201; 180) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N= 185; 166) | 4 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N= 199; 182) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=202; 184) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N= 200; 180) | 3 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N= 196; 182) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N= 199; 174) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N= 199; 181) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N= 203; 184) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N= 195; 181) | 3 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N= 191; 174) | 3 Subjects |
Secondary
Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types
Oncogenic HPV types included HPV-31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. Persistent cervical HPV infection (6-month definition) was defined as detection of the same HPV type in cervical specimens at 2 consecutive evaluations over a minimum of 5 months. Subjects with an event did not report the same event during the earlier studies. Subjects with an event were DNA negative for the corresponding HPV type at Month 6 in the primary study.
Time frame: Up to year 7
Population: The According-To-Protocol (ATP) cohort for efficacy included all subjects for whom differential treatment effect on efficacy was likely (i.e. those meeting all eligibility criteria in the primary study (580299/001), the first follow-up (580299/007) and the current study), who complied with the protocol and for whom efficacy data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N= 193; 173) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=191; 175) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=192; 173) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=191; 168) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=195; 177) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=183; 167) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=177; 160) | 2 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=189; 175) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=188; 174) | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=195; 177) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=183; 164) | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=191; 174) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-66 (N=183; 164) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-31 (N= 193; 173) | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-52 (N=177; 160) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-33 (N=191; 175) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-59 (N=195; 177) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-35 (N=192; 173) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-56 (N=189; 175) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-39 (N=191; 168) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-68 (N=191; 174) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-45 (N=195; 177) | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-58 (N=188; 174) | 1 Subjects |
| Placebo Group | Number of Subjects With Persistent Infection (6-month Definition) With Individual Oncogenic Non-vaccine HPV Types | HPV-51 (N=183; 167) | 0 Subjects |
Secondary
Number of Subjects With SAEs up to Year 8
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Time frame: up to year 8
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With SAEs up to Year 8 | 10 subjects |
| Placebo Group | Number of Subjects With SAEs up to Year 8 | 7 subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) up to Year 7
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Time frame: Up to year 7
Population: The analysis was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) up to Year 7 | 4 subjects |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) up to Year 7 | 5 subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) up to Year 9.
SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
Time frame: up to year 9
Population: The analyses was performed on the Total Cohort, which included all enrolled subjects who came at the first visit and received at least one vaccine dose (Cervarix or Placebo)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) up to Year 9. | 20 Subjects |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) up to Year 9. | 11 Subjects |