Infections, Papillomavirus
Conditions
Keywords
Human papillomavirus, vaccine, cervical cancer, cervical infection
Brief summary
This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits. Originally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48). The protocol posting has been updated as the study was extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.
Detailed description
This protocol posting has been updated following protocol amendment 6 dated 24 April 2014.
Interventions
BIOLOGICALHPV GSK 580299 vaccine
Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
BIOLOGICALPlacebo control
Subjects were planned to receive three doses of the placebo control administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Chinese females between and including 18 and 25 years of age at the time of the first vaccination. * Subjects who the investigator believes that they can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to enrolment. * Healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test. * Subjects must be of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination and agree to continue such precautions for 2 months after completion of the vaccination series. * Subject must have one single intact cervix.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine. * Concurrently participating in another clinical study, at any time during the study period (up to Month 24), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study. * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period. * Previous administration of components of the investigational vaccine. * History of chronic condition(s) requiring treatment such as cancer or autoimmune disease. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | At Month 24 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | At Month 48 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | At Month 57 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
| Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | At Month 72 | CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | At Months 24,48, 57 and 72 | Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | At Months 24, 48, 57 and 72 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. US). |
| Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | At Months 24, 48, 57 and 72 | CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | At Months 24, 48, 57 and 72 | CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
| Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Within 7 days (Days 0-6) after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling or redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination. |
| Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling or Redness = swelling/redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination. |
| Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling/redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination. |
| Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination |
| Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Within 7 days (Days 0-6) after vaccination | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0 degrees Celsius) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination, Related = symptoms assessed by the investigator as causally related to study vaccination, Grade 3 symptoms = prevented normal activity, Grade 3 urticaria = distributed on at least 4 body areas. |
| Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas. |
| Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas |
| Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within 7 days (Days 0-6) after vaccination | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas |
| Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | At Months 24,48, 57 and 72 | HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Within Days 0-29 after vaccination | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within Days 0-29 after vaccination | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms |
| Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Within Days 0-29 after vaccination | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Month 72 | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. |
| Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity | From Day 0 to Month 72 | Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | From Day 0 to Month 72 | Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | From Day 0 to Month 72 | Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | From Day 0 to Month 72 | Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | From Day 0 to Month 72 | Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing. |
| Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | From Day 0 to Month 72 | Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and MIssing. |
| Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | From Day 0 to Month 72 | Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and Missing. |
| Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | From Day 0 to Month 72 | Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing. |
| Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | at Months 0 (PRE), 7, 12, 24, 36, 48 and 72 | HPV-16 assay cut-off value was defined as greater than or equal to (≥) 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and ≥ 19 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 8 EL.U/mL prior to vaccination. |
| Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | at Months 0 (PRE), 7, 12, 24, 36, 48 and 72 | HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at PRE vaccination, Month 7, 12 and 24 and ≥ 18 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 7 EL.U/mL and 18 EL.U/mL prior to vaccination. |
| Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | at Months 0 (PRE), 7, 12, 24, 36, 48 and 72 | Titers were expressed as geometric mean titers calculated on all subjects, HPV-16 assay cut-off value was defined as greater than or equal to 8 EL.U/mL at Months 0, 7, 12 and 24 and greater than or equal to 19 EL.U/mL at Months 36, 48 and 72. HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at Month 0, 7, 12 and 24 and ≥ 18 EL.U/mL at Months 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ the assay cut-off value prior to vaccination. |
| Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Within Days 0-29 after vaccination | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity |
| Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | At Months 24, 48, 57 and 72 | Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. |
| Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | At Months 24, 48, 57 and 72 | Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. |
Countries
China
Participant flow
Recruitment details
This record provides the end-of-study analysis, including analyses at Month 24, 48, 57 and 72.
Pre-assignment details
Out of the 6081 subjects enrolled, 2 did not have any subject or vaccine number allocated and 28 did not receive any study vaccine dose, hence only 6051 subjects started the study.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. | 3,026 |
| Placebo Group Subjects received 3 doses of placebo. Placebo was administered intramuscularly in the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. | 3,025 |
| Total | 6,051 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Month 24 | Adverse Event | 3 | 3 |
| Month 24 | Lost to Follow-up | 9 | 9 |
| Month 24 | Migrated/moved from study area | 138 | 162 |
| Month 24 | Other | 18 | 27 |
| Month 24 | Protocol Violation | 3 | 1 |
| Month 24 | Serious Adverse Event | 2 | 3 |
| Month 24 | Withdrawal by Subject | 159 | 127 |
| Month 48 | Lost to Follow-up | 29 | 30 |
| Month 48 | Migrated/moved from study area | 76 | 75 |
| Month 48 | Other | 1 | 0 |
| Month 48 | Withdrawal by Subject | 68 | 63 |
| Month 72 | Lost to Follow-up | 6 | 8 |
| Month 72 | Migrated/moved from study area | 124 | 109 |
| Month 72 | Other | 0 | 1 |
| Month 72 | Withdrawal by Subject | 55 | 71 |
Baseline characteristics
| Characteristic | Cervarix Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 23.0 Years STANDARD_DEVIATION 1.7 | 23.0 Years STANDARD_DEVIATION 1.75 | 23.0 Years STANDARD_DEVIATION 1.73 |
| Race/Ethnicity, Customized Asian - Chinese Heritage | 3026 Participants | 3025 Participants | 6051 Participants |
| Sex: Female, Male Female | 3026 Participants | 3025 Participants | 6051 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3,026 | 3 / 3,025 |
| other Total, other adverse events | 2,786 / 3,026 | 2,548 / 3,025 |
| serious Total, serious adverse events | 56 / 3,026 | 81 / 3,025 |
Outcome results
Primary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Time frame: At Month 24
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for efficacy, which included all evaluable subjects for whom efficacy data were available and who had a normal or low-grade cytology (negative or atypical squamous cells of undetermined significance (ASC-US) or low-grade squamous intraepithelial lesion (LSIL)) at Month 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Sero negative, DNA negative HPV-16/18 | 1 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Sero negative, DNA negative HPV-18 | 0 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | DNA negative, HPV-16/18 | 1 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | DNA negative, HPV-16 | 1 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Sero negative, DNA negative HPV-16 | 1 Subjects |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | DNA negative, HPV-18 | 0 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Sero negative, DNA negative HPV-16 | 15 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | DNA negative, HPV-16/18 | 27 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | DNA negative, HPV-18 | 7 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Sero negative, DNA negative HPV-16/18 | 17 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | Sero negative, DNA negative HPV-18 | 3 Subjects |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 24 | DNA negative, HPV-16 | 21 Subjects |
Primary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Time frame: At Month 48
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | Sero negative, DNA negative HPV-16 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | Sero negative, DNA negative HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | DNA negative, HPV-16/18 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | DNA negative, HPV-16 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | DNA negative, HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | Sero negative, DNA negative HPV-16/18 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | Sero negative, DNA negative HPV-18 | 14 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | Sero negative, DNA negative HPV-16 | 33 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | DNA negative, HPV-18 | 18 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | DNA negative, HPV-16 | 45 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | DNA negative, HPV-16/18 | 61 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 48 | Sero negative, DNA negative HPV-16/18 | 45 Participants |
Primary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Time frame: At Month 57
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | Sero negative, DNA negative HPV-16/18 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | Sero negative, DNA negative HPV-16 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | Sero negative, DNA negative HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | DNA negative HPV-16/18 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | DNA negative HPV-16 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | DNA negative HPV-18 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | DNA negative HPV-16 | 57 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | Sero negative, DNA negative HPV-16/18 | 60 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | DNA negative HPV-16/18 | 78 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | Sero negative, DNA negative HPV-16 | 43 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | DNA negative HPV-18 | 23 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 57 | Sero negative, DNA negative HPV-18 | 19 Participants |
Primary
Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72
CIN1+ = CIN 1, 2, and 3, low/high-grade cervical glandular intraepithelial neoplasia (L/HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. Persistent infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an interval of approximately 6 months. The analyses were done on subjects HPV DNA negative at baseline (Month 0) and Month 6 and seronegative at baseline (Month 0) or on subjects DNA negative at baseline (Month 0) and Month 6, regardless of initial serostatus.
Time frame: At Month 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | Sero negative, DNA negative HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | DNA negative HPV-16 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | Sero negative, DNA negative HPV-16 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | DNA negative HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | DNA negative HPV-16/18 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | Sero negative, DNA negative HPV-16/18 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | Sero negative, DNA negative HPV-16 | 50 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | Sero negative, DNA negative HPV-16/18 | 69 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | Sero negative, DNA negative HPV-18 | 21 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | DNA negative HPV-16/18 | 91 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | DNA negative HPV-16 | 68 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN1+) and/or Persistent Infection (6 Month+ Definition) Associated With Human Papillomavirus (HPV)-16 and/or HPV-18 at Month 72 | DNA negative HPV-18 | 26 Participants |
Secondary
Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status
Titers were expressed as geometric mean titers calculated on all subjects, HPV-16 assay cut-off value was defined as greater than or equal to 8 EL.U/mL at Months 0, 7, 12 and 24 and greater than or equal to 19 EL.U/mL at Months 36, 48 and 72. HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at Month 0, 7, 12 and 24 and ≥ 18 EL.U/mL at Months 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below the assay cut-off value prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ the assay cut-off value prior to vaccination.
Time frame: at Months 0 (PRE), 7, 12, 24, 36, 48 and 72
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 72] | 343.7 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero- [Month 7] | 6964.3 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 12] | 3451.3 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 36] | 1074.6 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 48] | 828.4 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 72] | 678.1 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+ [pre-vaccination] | 27.4 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 12] | 3219.8 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 36] | 1290.3 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 72] | 724.4 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero- [pre-vaccination] | 3.5 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 48] | 387.7 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 12] | 1152.9 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 24] | 1253.2 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+ [Month 7] | 5672.0 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 24] | 1317.7 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 48] | 1006.0 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero- [Month 7] | 3357.4 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 12] | 1318.9 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 24] | 711.7 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 36] | 525.1 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero- [pre-vaccination] | 4.0 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+ [pre-vaccination] | 19.9 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+ [Month 7] | 3200.2 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 24] | 831.6 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 36] | 601.8 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 48] | 523.0 Titers |
| Cervarix Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 72] | 420.0 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 48] | 25.5 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero- [pre-vaccination] | 4.0 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 24] | 19.7 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+ [pre-vaccination] | 25.8 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 12] | 5.0 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 24] | 4.7 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 72] | 17.3 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 36] | 9.8 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero- [pre-vaccination] | 3.5 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 48] | 10.7 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 36] | 33.4 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero-, [Month 72] | 10.5 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero- [Month 7] | 3.9 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+ [pre-vaccination] | 25.2 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+ [Month 7] | 24.2 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 12] | 28.5 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 12] | 4.2 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 36] | 24.6 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+, [Month 48] | 25.1 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 12] | 20.2 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 24] | 5.0 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 72] | 28.3 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 48] | 9.8 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 36] | 9.7 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero- [Month 7] | 4.6 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero+, [Month 24] | 21.9 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-18, sero-, [Month 72] | 10.1 Titers |
| Placebo Group | Geometric Mean Titers for HPV-16/HPV-18 Antibodies, by Pre-vaccination Status | HPV-16, sero+ [Month 7] | 25.6 Titers |
Secondary
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling or redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Across Doses | 838 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Across doses | 2634 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Dose 1 | 512 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Dose 2 | 350 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Dose 2 | 19 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Dose 3 | 10 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Across Doses | 853 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Across Doses | 48 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Dose 1 | 105 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Dose 2 | 1650 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Dose 2 | 53 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Dose 3 | 1499 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Dose 3 | 86 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Across doses | 211 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Dose 3 | 432 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Dose 1 | 2439 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Across Doses | 5 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Dose 1 | 514 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Dose 1 | 34 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Dose 2 | 323 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Dose 3 | 447 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Dose 3 | 918 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Dose 2 | 17 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Across doses | 2166 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Dose 3 | 26 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Dose 1 | 326 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Across Doses | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Across doses | 64 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Dose 2 | 182 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Dose 3 | 149 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Dose 2 | 120 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Redness - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Across Doses | 408 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Swelling - Dose 1 | 215 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Across Doses | 5 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Dose 1 | 1815 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Dose 3 | 173 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Pain - Dose 1 | 23 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Pain - Dose 2 | 1062 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Grade 3 Swelling - Dose 1 | 4 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms | Any Redness - Across Doses | 517 Participants |
Secondary
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade, Grade 3 Redness, Swelling = redness/swelling above 50 millimeter All local symptoms were considered as related to the study vaccination
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Across doses | 58 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 3 | 23 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 1 | 40 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 1 | 123 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 1 | 41 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 1 | 5 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 2 | 78 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 2 | 21 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 3 | 74 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 3 | 5 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Across doses | 133 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 3 | 29 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Across doses | 11 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Across doses | 55 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 2 | 24 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 1 | 16 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 2 | 11 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 3 | 6 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Across doses | 28 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 1 | 14 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 2 | 8 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Across doses | 21 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Across doses | 3 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 1 | 82 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 2 | 55 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 3 | 43 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Across doses | 97 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 1 | 0 Participants |
Secondary
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity Grade 3 Swelling or Redness = swelling/redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Dose 3 | 240 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Dose 3 | 923 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Across doses | 1633 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Dose 1 | 290 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Dose 2 | 201 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Dose 1 | 65 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Dose 2 | 196 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Dose 2 | 12 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Dose 3 | 248 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Dose 3 | 54 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Across doses | 131 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Across doses | 486 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Dose 1 | 293 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Dose 1 | 18 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Across doses | 493 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Across doses | 28 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Dose 1 | 1519 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Dose 2 | 1029 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Dose 2 | 35 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Across doses | 1286 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Dose 1 | 1079 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Dose 3 | 530 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Dose 3 | 14 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Dose 1 | 174 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Across doses | 22 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Dose 1 | 11 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Dose 2 | 99 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Across doses | 280 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Pain - Dose 2 | 10 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Redness - Dose 3 | 95 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Redness - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Across doses | 4 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Dose 2 | 65 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Dose 1 | 138 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Pain - Dose 2 | 627 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Dose 3 | 85 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Swelling - Across doses | 228 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Swelling - Dose 1 | 4 Participants |
Secondary
Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Solicited local symptoms assessed were pain, redness and swelling. Any = solicited local symptom reported irrespective of intensity grade Grade 3 Pain = pain that prevented normal activity, Grade 3 Swelling or Redness = swelling/redness above (\>) 50 millimeter (mm). All local symptoms were considered as related to the study vaccination.
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Across doses | 80 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 3 | 576 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 2 | 148 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 1 | 919 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Across doses | 351 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 1 | 220 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 3 | 192 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 1 | 16 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 1 | 40 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 2 | 126 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 1 | 222 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 2 | 7 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 2 | 620 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 3 | 199 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 3 | 32 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 2 | 18 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Across doses | 359 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Across doses | 20 Participants |
| Cervarix Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Across doses | 1000 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 3 | 386 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Across doses | 30 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 1 | 151 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 3 | 78 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Across doses | 236 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 1 | 733 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 1 | 11 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Dose 2 | 434 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 3 | 12 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Pain - Across doses | 877 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Redness - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Redness - Dose 2 | 83 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 1 | 112 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 2 | 55 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Dose 3 | 64 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Swelling - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Swelling - Across doses | 179 Participants |
| Placebo Group | Number of Subjects With Any and Severe (Grade 3) Solicited Local Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Pain - Dose 2 | 7 Participants |
Secondary
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-US). Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M48 | 42 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M24 | 5 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M24 | 6 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M24 | 11 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M24 | 4 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M24 | 29 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M24 | 9 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M24 | 10 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 13 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 15 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M24 | 88 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M48 | 10 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M48 | 11 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M48 | 12 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M48 | 29 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M48 | 6 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M48 | 25 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M48 | 20 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M48 | 17 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M48 | 27 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M48 | 22 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M48 | 196 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M48 | 199 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M57 | 7 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M57 | 15 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M57 | 18 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M57 | 40 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M57 | 9 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M57 | 71 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M57 | 28 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 32 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M72 | 30 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M24 | 5 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M24 | 19 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M24 | 9 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M24 | 8 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M24 | 12 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M24 | 90 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M48 | 54 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 24 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 28 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M57 | 12 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M57 | 57 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M57 | 39 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M57 | 34 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M57 | 19 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M57 | 39 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 41 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M57 | 127 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M57 | 278 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M72 | 9 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M72 | 12 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M72 | 17 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M72 | 20 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M72 | 49 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M72 | 9 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M72 | 64 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M72 | 83 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M72 | 46 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M72 | 36 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M72 | 20 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M72 | 42 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 34 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 45 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M72 | 309 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M72 | 313 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M57 | 274 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M24 | 17 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M24 | 8 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M72 | 37 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M57 | 343 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M24 | 8 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M72 | 81 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M24 | 17 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M24 | 11 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M24 | 16 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M72 | 62 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M24 | 13 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M24 | 10 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M72 | 386 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 18 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M24 | 9 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 42 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M72 | 25 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M24 | 90 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M24 | 105 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M48 | 39 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M48 | 16 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M72 | 51 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M48 | 21 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M48 | 6 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M48 | 20 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M72 | 32 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M48 | 15 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 66 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M48 | 21 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 41 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M72 | 32 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M48 | 47 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M48 | 45 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M72 | 49 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M48 | 27 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M57 | 19 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M48 | 20 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M57 | 31 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M48 | 10 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M57 | 12 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M48 | 20 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-35 M72 | 21 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M48 | 19 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 92 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M72 | 352 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HRW-HPV M48 | 212 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-56 M57 | 43 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HR-HPV M48 | 238 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-39 M72 | 35 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16 M57 | 52 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-58 M57 | 42 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-18 M57 | 21 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31 M57 | 28 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M72 | 17 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-33 M57 | 29 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-59 M57 | 15 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-45 M72 | 12 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M57 | 39 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M57 | 64 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 61 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-52 M57 | 74 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 144 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-68 M57 | 30 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 127 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-66 M72 | 46 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With Any Oncogenic HPV Type | HPV-51 M72 | 78 Participants |
Secondary
Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection
Cytological abnormalities = atypical squamous cells of undetermined significance (ASC-DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. US).
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M48 | 5 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M57 | 10 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M57 | 7 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M72 | 5 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M72 | 12 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M57 | 4 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M72 | 4 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M72 | 9 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M48 | 39 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M24 | 16 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M57 | 52 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M24 | 12 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M72 | 83 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M57 | 21 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M24 | 24 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M48 | 16 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M24 | 17 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M72 | 60 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M24 | 8 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M72 | 17 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M48 | 39 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M72 | 44 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M48 | 28 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M72 | 62 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M48 | 12 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M72 | 24 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M57 | 53 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M48 | 53 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M57 | 38 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M57 | 16 Participants |
| Placebo Group | Number of Subjects With Any Cytological Abnormality Including Atypical Squamous Cells of Undetermined Significance (ASC-US+) Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M57 | 71 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0 degrees Celsius) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination, Related = symptoms assessed by the investigator as causally related to study vaccination, Grade 3 symptoms = prevented normal activity, Grade 3 urticaria = distributed on at least 4 body areas.
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Dose 1 | 143 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Dose 3 | 175 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Dose 2 | 229 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Dose 1 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Dose 3 | 390 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Dose 1 | 817 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Across doses | 684 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Dose 3 | 153 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Across doses | 968 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Dose 3 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Across doses | 25 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Across doses | 47 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Dose 1 | 332 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Across doses | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Dose 1 | 295 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Dose 1 | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Dose 2 | 447 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Dose 3 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Dose 2 | 123 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Across doses | 21 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Across doses | 523 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Dose 1 | 480 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Dose 2 | 232 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Across doses | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Dose 3 | 182 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Dose 1 | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Across doses | 744 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Dose 1 | 303 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Dose 3 | 61 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Dose 2 | 98 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Across doses | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Across doses | 449 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Dose 1 | 386 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Across doses | 1142 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Dose 2 | 175 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Dose 1 | 28 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Dose 3 | 124 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Across doses | 588 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Dose 1 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Dose 1 | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Across doses | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Dose 3 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Across doses | 29 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Across doses | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Dose 1 | 199 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Dose 1 | 177 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Dose 2 | 63 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Dose 1 | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Dose 3 | 67 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Dose 3 | 50 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Across doses | 16 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Across doses | 210 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Dose 3 | 443 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Dose 2 | 51 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Across doses | 26 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Dose 2 | 180 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Dose 1 | 634 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Dose 3 | 164 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Dose 2 | 51 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Across doses | 267 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Dose 3 | 64 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Across doses | 526 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Across doses | 409 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Dose 3 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Dose 1 | 362 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Dose 2 | 79 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Dose 3 | 191 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Dose 1 | 332 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Dose 1 | 476 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Dose 2 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Dose 2 | 118 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Dose 3 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Across doses | 270 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Across doses | 213 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Across doses | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Dose 1 | 109 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Dose 2 | 32 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Dose 3 | 26 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Arthralgia - Across doses | 149 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Dose 1 | 769 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Dose 2 | 367 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Dose 3 | 309 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Dose 1 | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Dose 3 | 256 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Across doses | 833 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Dose 1 | 368 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Dose 2 | 111 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Dose 1 | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Dose 2 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Gastrointestinal - Across doses | 22 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Dose 2 | 65 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Dose 3 | 43 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Across doses | 275 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Dose 1 | 509 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Dose 2 | 208 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Dose 3 | 146 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Headache - Across doses | 682 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Across doses | 20 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Dose 1 | 347 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Dose 2 | 161 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Dose 3 | 109 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Across doses | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Dose 1 | 188 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Dose 3 | 92 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Across doses | 287 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Dose 2 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Across doses | 59 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Dose 1 | 19 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Dose 1 | 163 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Dose 2 | 51 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Arthralgia - Dose 3 | 32 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Arthralgia - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Dose 3 | 107 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Headache - Across doses | 505 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Dose 1 | 249 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Dose 2 | 73 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Myalgia - Across doses | 360 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Myalgia - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Myalgia - Dose 2 | 57 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Dose 1 | 42 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Rash - Dose 3 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Rash - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Dose 2 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Rash - Across doses | 33 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Dose 1 | 433 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Dose 2 | 236 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Dose 3 | 175 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >37.0°C Fever - Across doses | 697 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | >39.0°C Fever - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Dose 1 | 344 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Dose 2 | 168 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Dose 3 | 117 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fever - Across doses | 539 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Dose 1 | 20 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Dose 3 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Urticaria - Across doses | 28 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Urticaria - Across doses | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Dose 1 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Dose 2 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Urticaria - Across doses | 16 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Fatigue - Across doses | 1018 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Fatigue - Across doses | 29 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Dose 1 | 581 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Fatigue - Dose 2 | 32 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Dose 3 | 61 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Any Gastrointestinal - Across doses | 473 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Related Gastrointestinal - Dose 1 | 200 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Dose 1 | 347 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms. | Grade 3 Headache - Dose 2 | 4 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Across doses | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 1 | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 2 | 16 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Across doses | 29 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 1 | 17 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 1 | 35 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 2 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 2 | 26 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Across doses | 25 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 1 | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 3 | 20 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Across doses | 58 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 2 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 1 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Across doses | 19 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 2 | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Across doses | 36 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Across doses | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Across doses | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 1 | 16 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 2 | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 3 | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 1 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Across doses | 32 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 1 | 44 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 2 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 1 | 13 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 2 | 29 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 2 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 3 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Across doses | 23 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Across doses | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 3 | 24 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 2 | 17 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Across doses | 66 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 3 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Across doses | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 1 | 25 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 1 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 1 | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Across doses | 10 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Across doses | 6 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 1 | 46 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 2 | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 3 | 14 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Across doses | 53 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 1 | 36 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 2 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 3 | 14 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Across doses | 47 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 1 | 20 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 2 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Across doses | 24 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Across doses | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Across doses | 12 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 1 | 20 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 2 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 3 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Across doses | 31 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 1 | 11 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 2 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Across doses | 22 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 1 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 2 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Across doses | 15 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 2 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Across doses | 13 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 2 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Across doses | 26 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 1 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 2 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Across doses | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 1 | 8 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas.
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Dose 3 | 97 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Across doses | 300 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Dose 1 | 386 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Dose 1 | 233 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Dose 1 | 226 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Dose 2 | 73 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Dose 2 | 223 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Dose 3 | 114 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Across doses | 328 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Dose 3 | 248 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Dose 1 | 124 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Dose 1 | 182 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Dose 1 | 89 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Dose 2 | 66 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Dose 1 | 194 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Dose 1 | 186 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Dose 2 | 59 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Dose 3 | 33 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Dose 3 | 100 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Dose 2 | 29 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Across doses | 280 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Across doses | 240 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Dose 1 | 19 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Dose 2 | 33 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 1 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Dose 3 | 37 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Across doses | 32 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Across doses | 592 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Across doses | 128 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Across doses | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Dose 3 | 40 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Dose 1 | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Dose 1 | 114 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Dose 1 | 509 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Across doses | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Dose 2 | 40 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Dose 1 | 296 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Across doses | 164 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Dose 2 | 146 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Dose 3 | 25 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Dose 3 | 107 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Dose 2 | 255 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Across doses | 464 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Across doses | 154 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Dose 3 | 278 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Dose 2 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Dose 1 | 284 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Across doses | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Dose 2 | 118 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Dose 2 | 106 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Across doses | 711 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Dose 3 | 74 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Dose 3 | 111 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Across doses | 355 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Dose 1 | 13 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Across doses | 408 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Dose 2 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Dose 1 | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Across doses | 18 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Dose 2 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Across doses | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Across doses | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Dose 2 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Dose 2 | 89 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Across doses | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Across doses | 16 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Across doses | 11 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Dose 1 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Across doses | 471 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Dose 1 | 212 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Dose 1 | 96 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Dose 2 | 34 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Across doses | 128 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Arthralgia - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Dose 1 | 62 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Dose 2 | 20 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Dose 3 | 16 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Arthralgia - Across doses | 87 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Dose 1 | 443 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Dose 2 | 219 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Dose 3 | 165 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Fatigue - Across doses | 588 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Fatigue - Across doses | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Dose 1 | 321 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Dose 2 | 185 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fatigue - Dose 3 | 135 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Dose 1 | 227 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Dose 2 | 65 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Dose 3 | 35 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Gastrointestinal - Across doses | 287 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 1 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Gastrointestinal - Across doses | 10 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Dose 1 | 122 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Dose 2 | 40 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Dose 3 | 27 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Gastrointestinal - Across doses | 170 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Dose 1 | 315 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Dose 2 | 120 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Dose 3 | 85 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Headache - Across doses | 404 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Dose 1 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Headache - Across doses | 12 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Dose 2 | 96 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Dose 3 | 60 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Headache - Across doses | 298 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Dose 1 | 154 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Dose 2 | 38 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Dose 3 | 74 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Myalgia - Across doses | 214 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Myalgia - Across doses | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Dose 1 | 117 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Dose 2 | 33 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Dose 3 | 62 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Myalgia - Across doses | 173 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Dose 1 | 26 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Dose 2 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Dose 3 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Rash - Across doses | 37 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Rash - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Dose 1 | 11 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Rash - Across doses | 22 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Dose 1 | 261 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Dose 2 | 149 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Dose 3 | 108 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >37.0°C Fever - Across doses | 427 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | >39.0°C Fever - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Dose 1 | 211 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Dose 2 | 109 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Dose 3 | 72 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Fever - Across doses | 333 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Dose 1 | 15 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Dose 2 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Urticaria - Across doses | 19 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Grade 3 Urticaria - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Dose 2 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Related Urticaria - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Any Arthralgia - Dose 3 | 18 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, fever (= axillary temperature above 37.0°C) and urticaria. Any = any solicited general symptom reported irrespective of intensity grade and relationship to vaccination Related = symptoms assessed by the investigator as causally related to study vaccination Grade 3 symptoms = symptoms that prevented normal activity Grade 3 urticaria = urticaria distributed on at least 4 body areas
Time frame: Within 7 days (Days 0-6) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Across doses | 82 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 1 | 247 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Across doses | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 1 | 62 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Across doses | 225 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 3 | 61 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 1 | 75 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 2 | 30 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 3 | 27 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Across doses | 106 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 1 | 54 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 2 | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 3 | 24 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 1 | 307 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 2 | 191 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 3 | 27 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Across doses | 430 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 2 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Across doses | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 2 | 170 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 3 | 142 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Across doses | 375 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 1 | 112 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 2 | 57 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 3 | 31 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Across doses | 168 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 1 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 2 | 39 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 3 | 25 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Across doses | 112 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 1 | 191 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 2 | 111 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 3 | 80 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Across doses | 275 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 3 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Across doses | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 1 | 145 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 2 | 91 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 3 | 67 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 1 | 129 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 2 | 45 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Across doses | 195 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Across doses | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 1 | 109 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 2 | 39 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 3 | 53 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Across doses | 169 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 1 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 3 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Across doses | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Across doses | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 1 | 183 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 2 | 85 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 3 | 73 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Across doses | 278 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Across doses | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 1 | 159 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 2 | 68 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 3 | 49 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Across doses | 232 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 1 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Across doses | 11 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Across doses | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 3 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 2 | 65 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 1 | 172 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Across doses | 206 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Across doses | 12 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 1 | 78 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 3 | 47 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 1 | 94 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 2 | 87 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 2 | 35 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Dose 3 | 35 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Myalgia - Across doses | 145 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Dose 3 | 67 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 2 | 17 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 3 | 14 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Across doses | 85 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 1 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >37.0°C Fever - Across doses | 270 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Dose 3 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Across doses | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Arthralgia - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Myalgia - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 1 | 47 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Dose 2 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 1 | 70 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Arthralgia - Across doses | 62 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 1 | 325 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 2 | 24 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 2 | 147 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Dose 3 | 14 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Dose 3 | 30 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Fatigue - Across doses | 429 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 1 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 1 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Myalgia - Across doses | 113 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Dose 3 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 1 | 16 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Fatigue - Across doses | 11 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 1 | 259 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Urticaria - Across doses | 9 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 2 | 118 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Dose 3 | 120 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | >39.0°C Fever - Across doses | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fatigue - Across doses | 361 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 1 | 140 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 2 | 46 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Rash - Across doses | 22 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Dose 3 | 26 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 1 | 133 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Gastrointestinal - Across doses | 185 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 1 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Across doses | 5 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Gastrointestinal - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 2 | 59 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 2 | 25 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Dose 3 | 16 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Urticaria - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Gastrointestinal - Across doses | 105 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Rash - Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 1 | 193 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Dose 3 | 45 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 2 | 88 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Dose 3 | 61 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Urticaria - Dose 2 | 1 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Headache - Across doses | 277 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Any Arthralgia - Dose 1 | 67 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Fever - Across doses | 206 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Grade 3 Headache - Across doses | 8 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Rash - Across doses | 11 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Solicited General Symptoms, for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Related Headache - Dose 1 | 134 Participants |
Secondary
Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs)
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Related = event assessed by the investigator as causally related to study vaccination Grade 3 = event that prevented normal activity
Time frame: Within Days 0-29 after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Grade 3 AEs | 18 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Any AEs | 793 Participants |
| Cervarix Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Related AEs | 35 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Grade 3 AEs | 18 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Any AEs | 775 Participants |
| Placebo Group | Number of Subjects With Any, Severe (Grade 3) and Causally Related to Vaccination Unsolicited Adverse Events (AEs) | Related AEs | 32 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type
CIN1+ = CIN grades 1, 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M72 | 42 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M24 | 11 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M48 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M48 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M57 | 7 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M57 | 4 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M72 | 7 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M72 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M24 | 11 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M48 | 7 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M48 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 5 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M48 | 27 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M48 | 27 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M57 | 11 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M57 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 5 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M57 | 37 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M57 | 37 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M72 | 5 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M72 | 11 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M72 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 7 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 8 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M72 | 42 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M48 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M48 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M57 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M48 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M72 | 9 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M48 | 9 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M48 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M48 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M72 | 53 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M48 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M48 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 27 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M57 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M72 | 12 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M57 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 21 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M57 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M57 | 49 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M57 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M48 | 35 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M57 | 9 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M72 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M72 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M72 | 6 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M48 | 44 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M72 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M57 | 60 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M72 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M72 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M57 | 13 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M72 | 64 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M72 | 9 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M57 | 6 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M72 | 13 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 28 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M57 | 9 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M57 | 11 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M24 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M72 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M24 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M24 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M57 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 11 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M24 | 14 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M24 | 17 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M72 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M48 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M57 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M48 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M72 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M48 | 4 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection
CIN1+ = CIN grades 1, 2, and3, low-grade cervical glandular intraepithelial neoplasia (LCGIN), high grade cervical glandular intraepithelial neoplasia (HCGIN), adenocarcinoma in-situ (AIS) or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M72 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M57 | 18 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M48 | 14 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M57 | 13 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M72 | 18 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M57 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M72 | 13 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M48 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M72 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M48 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M72 | 15 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M57 | 15 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M72 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M57 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M48 | 12 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M57 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M48 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M72 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN1+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M48 | 4 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type
CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M57 | 10 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M72 | 13 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M72 | 13 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M57 | 10 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M48 | 8 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M48 | 8 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M72 | 5 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M57 | 4 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M48 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M72 | 26 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M57 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 7 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M57 | 16 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M72 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M72 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M72 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M72 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 18 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M24 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M24 | 6 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-51 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M48 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-58 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M48 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 11 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M48 | 9 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M48 | 15 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M57 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M57 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-52 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-56 M57 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-59 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-66 M57 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-68 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 17 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HR-HPV M57 | 25 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-16 M72 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-18 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M72 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-33 M72 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-35 M72 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-39 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-45 M72 | 2 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M72 | 17 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With Cervical Infection With Any Oncogenic HPV Type | HPV-31 M24 | 0 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection
CIN2+ = CIN grades 2 and 3, LCGIN, HCGIN, AIS or invasive cervical cancer. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M72 | 1 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M72 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M48 | 6 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M48 | 6 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M57 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M57 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M48 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M72 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M72 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16/18 M57 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-18 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M57 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16/18 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Sero negative, DNA negative HPV-16 M72 | 8 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M24 | 4 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-16 M57 | 10 Participants |
| Placebo Group | Number of Subjects With Histopathologically-confirmed CIN2+ Associated With HPV-16 and/or HPV-18 Cervical Infection | Overall, HPV-18 M24 | 0 Participants |
Secondary
Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
HPV-16 assay cut-off value was defined as greater than or equal to (≥) 8 ELISA units per millilitre (EL.U/mL) at PRE vaccination, Month 7, 12 and 24 and ≥ 19 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 8 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 8 EL.U/mL prior to vaccination.
Time frame: at Months 0 (PRE), 7, 12, 24, 36, 48 and 72
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero+, [Month 72] | 65 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero- [pre-vaccination] | 0 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+ [pre-vaccination] | 103 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero- [Month 7] | 236 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+ [Month 7] | 103 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero-, [Month12] | 222 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+, [Month12] | 99 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero-, [Month24] | 207 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+, [Month24] | 94 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero-, [Month 36] | 183 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero+, [Month 36] | 76 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero-, [Month 48] | 195 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero+, [Month 48] | 83 Participants |
| Cervarix Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero-, [Month 72] | 153 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero+, [Month 36] | 44 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero+, [Month 72] | 22 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero-, [Month24] | 31 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero- [pre-vaccination] | 0 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero+, [Month 48] | 48 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+ [pre-vaccination] | 105 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+, [Month24] | 85 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero- [Month 7] | 17 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero-, [Month 48] | 12 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+ [Month 7] | 97 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero-, [Month 36] | 4 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero-, [Month12] | 39 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥19 EL.U/mL, sero-, [Month 72] | 10 Participants |
| Placebo Group | Number of Subjects With HPV-16 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥8 EL.U/mL, sero+, [Month12] | 93 Participants |
Secondary
Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status
HPV-18 assay cut-off value was defined as ≥ 7 EL.U/mL at PRE vaccination, Month 7, 12 and 24 and ≥ 18 EL.U/mL at Month 36, 48 and 72. Seronegative (Sero-) subjects are subjects who had an antibody concentration below 7 EL.U/mL and 18 EL.U/mL prior to vaccination. Seropositive (Sero+) subjects are subjects who had an antibody concentration ≥ 7 EL.U/mL and 18 EL.U/mL prior to vaccination.
Time frame: at Months 0 (PRE), 7, 12, 24, 36, 48 and 72
Population: The analysis was performed on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects in the immunogenicity subset for whom data concerning immunogenicity endpoint measures were available at the specified time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero- [Month 36] | 218 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ PRE | 60 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero+ [Month 48] | 47 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- [Month 7] | 278 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero+ [Month 36] | 41 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ [Month 7] | 60 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero- [Month 72] | 183 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- [Month 12] | 263 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero- [Month 48] | 231 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ [Month 12] | 57 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero+ [Month 72] | 37 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ [Month 24] | 51 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- PRE | 0 Participants |
| Cervarix Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- [Month 24] | 249 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero+ [Month 72] | 19 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- [Month 24] | 63 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ [Month 24] | 33 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero- [Month 36] | 13 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero- [Month 48] | 14 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero+ [Month 48] | 23 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero- [Month 72] | 14 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- PRE | 0 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ PRE | 47 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- [Month 7] | 14 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ [Month 7] | 39 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero- [Month 12] | 34 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 7 EL.U/mL, sero+ [Month 12] | 32 Participants |
| Placebo Group | Number of Subjects With HPV-18 Antibody Concentration Equal to or Above the Assay Cut-off Value, by Pre-vaccination Status | ≥ 18 EL.U/mL, sero+ [Month 36] | 22 Participants |
Secondary
Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M48 | 18 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M24 | 8 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M24 | 14 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M24 | 19 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M24 | 17 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M24 | 42 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M24 | 8 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M24 | 69 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M24 | 90 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M24 | 34 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M24 | 28 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M24 | 16 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M24 | 37 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M24 | 33 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 36 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 54 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M24 | 313 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M24 | 323 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M24 | 13 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M48 | 13 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M48 | 29 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M48 | 35 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M48 | 80 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M48 | 56 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M48 | 13 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M48 | 117 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M48 | 168 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M48 | 63 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M48 | 35 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M48 | 74 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M48 | 59 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 62 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 89 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M48 | 536 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M48 | 552 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M57 | 26 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M57 | 18 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M57 | 33 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M57 | 40 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M57 | 49 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M57 | 136 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M57 | 18 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M57 | 152 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M57 | 227 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M57 | 93 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M57 | 77 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M57 | 47 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M57 | 96 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M57 | 91 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 80 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 120 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M57 | 692 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M57 | 710 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M72 | 32 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M72 | 18 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M72 | 35 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M72 | 43 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M72 | 154 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M72 | 18 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M72 | 166 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M72 | 251 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M72 | 104 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M72 | 83 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M72 | 52 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M72 | 103 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M72 | 101 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 85 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 131 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M72 | 764 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M48 | 29 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M72 | 53 Subjects |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M72 | 744 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M72 | 852 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M24 | 43 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M57 | 74 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M24 | 30 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M72 | 81 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M24 | 25 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M57 | 74 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M24 | 22 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M72 | 75 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M24 | 15 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M57 | 69 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M24 | 32 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M72 | 86 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M24 | 17 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M57 | 55 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M24 | 57 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M72 | 124 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M24 | 87 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M57 | 121 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M24 | 37 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M72 | 65 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M24 | 34 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M57 | 38 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M24 | 20 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M72 | 914 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M24 | 33 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M57 | 187 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M24 | 32 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M72 | 133 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 60 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M57 | 264 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 126 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M72 | 107 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M24 | 324 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M57 | 106 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M24 | 364 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M72 | 40 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M48 | 88 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M57 | 99 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-18 M48 | 50 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M72 | 65 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-33 M48 | 52 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M57 | 62 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-35 M48 | 38 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M72 | 204 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-39 M48 | 78 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M57 | 111 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 175 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-45 M48 | 25 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M57 | 95 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-51 M48 | 131 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M72 | 284 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-52 M48 | 176 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 159 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M48 | 70 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M48 | 62 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31 M48 | 59 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-59 M48 | 44 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 329 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-66 M48 | 73 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-56 M72 | 113 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-68 M48 | 61 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M57 | 800 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 119 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 356 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 239 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M57 | 862 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HRW-HPV M48 | 591 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-58 M72 | 111 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HR-HPV M48 | 646 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M72 | 139 Subjects |
| Placebo Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic HPV Type | HPV-16 M57 | 127 Subjects |
Secondary
Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18
HPV-16 and/or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 DNA PCR assay at the time point considered. - DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA) - Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Time frame: At Months 24,48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M48 | 22 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M24 | 9 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M24 | 7 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M24 | 20 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M24 | 13 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M24 | 8 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M24 | 15 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M48 | 13 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M48 | 10 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M57 | 29 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M57 | 16 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M57 | 14 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M57 | 43 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M57 | 26 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M57 | 18 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M72 | 34 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M72 | 21 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M72 | 14 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M72 | 49 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M72 | 32 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M72 | 18 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M57 | 142 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M24 | 49 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M72 | 103 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M24 | 30 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M57 | 92 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M24 | 21 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M57 | 57 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M24 | 70 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M72 | 63 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M24 | 43 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M57 | 189 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M24 | 30 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M72 | 81 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M48 | 96 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M57 | 127 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M48 | 62 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M72 | 204 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M48 | 39 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M57 | 74 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16/18 M48 | 21 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-18 M48 | 5 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M72 | 156 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M48 | 16 Participants |
| Placebo Group | Number of Subjects With Incident Cervical Infection With HPV-16 and/or HPV-18 | DNA negative HPV-16 M72 | 139 Participants |
Secondary
Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity | 186 Participants |
| Placebo Group | Number of Subjects With Medically Significant Conditions (MSC) Regardless of Causal Relationship to Vaccination and Intensity | 185 Participants |
Secondary
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | 10 Participants |
| Placebo Group | Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | 9 Participants |
Secondary
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | 122 Participants |
| Placebo Group | Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | 110 Participants |
Secondary
Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Medically significant conditions were defined as: adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | 64 Participants |
| Placebo Group | Number of Subjects With Medically Significant Conditions Regardless of Causal Relationship to Vaccination and Intensity for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | 75 Participants |
Secondary
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: At Months 24,48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M48 | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M24 | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M24 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M24 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M24 | 21 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M24 | 21 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M48 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M48 | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M48 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M48 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M48 | 20 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M48 | 41 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M48 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M48 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 13 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M48 | 122 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M48 | 122 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M57 | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M57 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M57 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M57 | 25 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M57 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M57 | 28 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M57 | 70 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M57 | 15 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M57 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M57 | 17 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M57 | 192 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M57 | 192 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M72 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M72 | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M72 | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M72 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M72 | 25 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M72 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M72 | 28 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M72 | 72 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M72 | 14 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M72 | 15 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M72 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M72 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 16 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 17 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M72 | 196 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M72 | 196 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 3 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M48 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M48 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M48 | 9 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M57 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M57 | 14 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M57 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 15 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 16 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M72 | 17 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M57 | 24 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M57 | 63 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M57 | 11 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M72 | 12 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M57 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M48 | 9 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M24 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 27 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M57 | 10 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M57 | 188 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 64 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M57 | 215 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M24 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 27 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 1 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M72 | 30 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M24 | 14 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M72 | 192 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M24 | 15 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M72 | 8 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M48 | 17 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M48 | 4 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M48 | 5 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M72 | 16 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M72 | 219 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M48 | 6 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M72 | 9 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M57 | 12 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M48 | 16 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M72 | 9 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M48 | 1 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M24 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M48 | 16 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M72 | 22 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M57 | 9 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M48 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M72 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M72 | 25 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 40 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M48 | 11 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M48 | 119 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M72 | 65 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M48 | 137 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M57 | 29 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M48 | 40 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M57 | 8 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M72 | 12 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M57 | 16 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 63 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M72 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M57 | 9 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M48 | 5 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M57 | 22 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M72 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M57 | 2 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M72 | 10 Participants |
Secondary
Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18
Persistent infection (12-month+ definition) is defined as the detection of the same HPV type(s) (by PCR) in cervical samples at all available time points over an interval of approximately 12 months. Subjects had at least 10 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by Enzyme-linked Immunosorbent Assay (ELISA). Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M57 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M24 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M24 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M24 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M24 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M24 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M48 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M48 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M48 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M48 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M48 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M48 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M57 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M57 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M57 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M57 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M57 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M72 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M72 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M72 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M72 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M72 | 1 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M72 | 0 Subjects |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M24 | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M72 | 32 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M24 | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M57 | 32 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M24 | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M72 | 38 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M24 | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M57 | 24 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M24 | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M72 | 24 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M24 | 2 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M57 | 8 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M24 | 0 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M57 | 37 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M48 | 21 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M72 | 8 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M48 | 16 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M57 | 29 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M48 | 5 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M72 | 8 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16/18 M48 | 22 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M57 | 8 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M48 | 17 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-16 M72 | 30 Subjects |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (12-month+ Definition) With HPV-16 and/or HPV-18 | Overall, HPV-18 M48 | 5 Subjects |
Secondary
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type
Oncogenic HPV types assessed were HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68 individually or in combination. Subjects were HPV DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus. HRW-HPV=All high-risk (oncogenic) HPV types excluding HPV-16 and HPV-18 HR-HPV=High-risk (oncogenic) HPV types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M48 | 34 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M57 | 47 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M24 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M57 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M48 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M57 | 59 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 13 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M57 | 109 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M48 | 49 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M24 | 36 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M57 | 32 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M48 | 84 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M57 | 15 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M57 | 32 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M57 | 31 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M24 | 114 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M57 | 28 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M48 | 25 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 28 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M24 | 6 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 30 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M48 | 25 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M57 | 319 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M24 | 115 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M57 | 320 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M48 | 14 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M24 | 7 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M48 | 19 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M72 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M72 | 16 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M48 | 21 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M72 | 19 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M24 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M72 | 63 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 27 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M72 | 8 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M72 | 69 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 29 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M72 | 38 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M24 | 13 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M72 | 16 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M48 | 257 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M72 | 36 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M48 | 10 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M72 | 32 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M48 | 258 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 33 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M24 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 35 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M72 | 381 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M72 | 382 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M72 | 128 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M48 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M72 | 43 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M24 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M57 | 10 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M48 | 13 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M24 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M57 | 13 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M24 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 12 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M57 | 17 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M24 | 21 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M72 | 146 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M24 | 6 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M24 | 14 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M24 | 23 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M24 | 5 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M24 | 12 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M24 | 8 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M24 | 19 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M24 | 42 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M24 | 98 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M24 | 116 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M48 | 40 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M48 | 15 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M48 | 23 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M48 | 19 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M48 | 15 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M48 | 29 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M48 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M48 | 42 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M48 | 72 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M48 | 29 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M48 | 29 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M48 | 13 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M48 | 25 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M48 | 20 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M48 | 46 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M48 | 97 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M48 | 275 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M48 | 312 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M57 | 51 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M57 | 21 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M57 | 29 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M57 | 25 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M57 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M57 | 41 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M57 | 8 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M57 | 58 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M57 | 97 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M57 | 36 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M57 | 40 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M57 | 15 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M57 | 29 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M57 | 30 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M57 | 59 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16/18/31/33/45 M57 | 126 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M57 | 357 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M57 | 400 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M72 | 62 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-18 M72 | 24 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31 M72 | 31 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M72 | 30 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M72 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M72 | 50 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M72 | 10 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-51 M72 | 73 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-58 M72 | 49 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-59 M72 | 16 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-66 M72 | 37 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-68 M72 | 36 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-31/33/45 M72 | 68 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HRW-HPV M72 | 418 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-52 M72 | 117 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-56 M72 | 41 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HR-HPV M72 | 466 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-16 M24 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-33 M24 | 8 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-35 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-39 M24 | 9 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With Any Oncogenic HPV Type | HPV-45 M24 | 5 Participants |
Secondary
Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18
Persistent HPV-16 and/or HPV-18 infection (6-month+ definition) = at least 2 positive HPV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assays for the same viral genotype with no negative DNA sample between the two positive DNA samples, over an interval of approximately 6 months. Subjects had at least 5 months of follow-up after Month 12. DNA- and sero-: subjects HPV DNA negative at Months 0 and 6 by PCR and seronegative at Month 0 for the corresponding HPV-type by ELISA Overall: subjects DNA- at Months 0 and 6 for the corresponding HPV-type, regardless of initial serostatus.
Time frame: At Months 24, 48, 57 and 72
Population: The analysis was performed on the ATP cohort for efficacy, which included all evaluable subjects for whom data concerning efficacy outcome measures were available and who had a normal or low-grade cytology (negative or ASC-US or LSIL) at Month 0.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M24 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M24 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M48 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M48 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M57 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M57 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M72 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M72 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M72 | 0 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M72 | 62 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M24 | 15 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M57 | 54 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M24 | 13 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M72 | 63 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M24 | 3 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M57 | 39 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M24 | 24 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M72 | 83 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M24 | 18 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M57 | 17 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M24 | 7 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M72 | 46 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16/18 M48 | 39 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M57 | 70 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-16 M48 | 30 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M72 | 24 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M48 | 11 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M57 | 51 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16/18 M48 | 53 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Sero negative, DNA negative HPV-18 M72 | 19 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-16 M48 | 40 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M57 | 21 Participants |
| Placebo Group | Number of Subjects With Persistent Cervical Infection (6-month+ Definition) With HPV-16 and/or HPV-18 | Overall HPV-18 M48 | 15 Participants |
Secondary
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Live infant NO ACA | 648 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Live infant CA | 5 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Elective termination NO ACA | 139 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Stillbirth NO ACA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Lost to follow up | 20 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Elective termination CA | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Ectopic pregnancy | 7 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Spontaneous abortion NO ACA | 16 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Stillbirth CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Pregnancy ongoing | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Stillbirth CA | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Ectopic pregnancy | 7 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Live infant CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Lost to follow up | 13 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Elective termination NO ACA | 158 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Spontaneous abortion NO ACA | 13 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Stillbirth NO ACA | 2 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Live infant NO ACA | 657 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Pregnancy ongoing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies | Elective termination CA | 2 Participants |
Secondary
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up and Pregnancy ongoing.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination CA | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth NO ACA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination NO ACA | 6 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Ectopic pregnancy | 3 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Lost to follow up | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Pregnancy ongoing | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Spontaneous abortion NO ACA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Missing | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant NO ACA | 29 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Missing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant NO ACA | 26 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination NO ACA | 12 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Ectopic pregnancy | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Spontaneous abortion NO ACA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth NO ACA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Lost to follow up | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | Pregnancy ongoing | 0 Participants |
Secondary
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and MIssing.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Live infant CA | 5 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Elective termination NO ACA | 87 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Stillbirth CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Lost to follow up | 14 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Live infant NO ACA | 436 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Elective termination CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Ectopic pregnancy | 2 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Spontaneous abortion NO ACA | 10 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Spontaneous abortion CA [Month 24] | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Stillbirth NO ACA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Pregnancy ongoing | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Missing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Pregnancy ongoing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Live infant CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Ectopic pregnancy | 3 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Elective termination NO ACA | 97 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Stillbirth NO ACA | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Stillbirth CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Spontaneous abortion NO ACA | 8 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Lost to follow up | 9 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Missing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Live infant NO ACA | 411 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Spontaneous abortion CA [Month 24] | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | Elective termination CA | 0 Participants |
Secondary
Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
Outcomes of pregnancies were Live infant NO apparent congenital anomaly (ACA), Live infant CA, Elective termination NO ACA, Elective termination CA, Ectopic pregnancy, Spontaneous abortion NO ACA, Stillbirth NO ACA, Stillbirth CA, Lost to follow up, Pregnancy ongoing and Missing.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth NO ACA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant NO ACA | 212 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination NO ACA | 52 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination CA | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Ectopic pregnancy | 5 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Spontaneous abortion NO ACA | 6 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth CA | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Lost to follow up | 6 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Pregnancy ongoing | 0 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Missing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Lost to follow up | 4 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Spontaneous abortion NO ACA | 5 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant NO ACA | 246 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth NO ACA | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Live infant CA | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Missing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination NO ACA | 61 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Stillbirth CA | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Elective termination CA | 2 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Pregnancy ongoing | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Outcomes of Reported Pregnancies Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | Ectopic pregnancy | 4 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From Day 0 to Month 72
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | 56 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | 81 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within Days 0-29 after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | 32 Participants |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events for Subjects DNA Positive for Either HPV-16 or HPV-18 at Baseline | 40 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within Days 0-29 after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | 497 Participants |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events for Subjects Seronegative and DNA Negative for Both HPV-16 and HPV-18 at Baseline | 468 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
Time frame: Within Days 0-29 after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | 295 Participants |
| Placebo Group | Number of Subjects With Unsolicited Adverse Events for Subjects Seropositive and/or DNA Positive for Either HPV-16 or HPV-18 at Baseline | 307 Participants |