Infections, Papillomavirus
Conditions
Keywords
HPV Vaccine Efficacy
Brief summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.
Interventions
BIOLOGICALHPV-16/18 vaccine (Cervarix™)
Intramuscular injection, 3 doses
BIOLOGICALAimmugen™
Intramuscular injection, 3 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
: * Subjects who the investigator/co-investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * A Japanese female subject between, and including, 20 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from the subject prior to enrolment. * Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study. * Subjects must have a negative urine pregnancy test. * Subjects must be of non-childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. * Subject must have an intact cervix
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine/control within 30 days preceding the first dose of study vaccine/control, or planned use during the study period. * Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study. * A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to 2 months after the last vaccine dose * previous administration of components of the investigational vaccine * 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 the first dose of vaccine. Routine vaccines may be allowed up to 8 days before the first dose of study vaccine. * Previous vaccination against HPV. * History of vaccination against hepatitis A or a known clinical history of hepatitis A disease * Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination * History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines * Hypersensitivity to latex * Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * Cancer or autoimmune disease under treatment. * History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test. * Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be performed * Acute disease at the time of enrolment. * Oral temperature \>= 37.5°C / axillary temperature \> 37.5°C. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | Throughout the study period (up to Month 24) | Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (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 approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | Up to Month 24 | Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6. |
| Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | Up to Month 24 | Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6. |
| Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Up to Month 24 | Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. |
| Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Up to Month 24 | Persistent infection for oncogenic HPV types is defined as 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 approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6\]. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. |
| Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Up to Month 24 | Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. |
| Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Up to Month 24 | Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68. |
| Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24 | Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL. |
| Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | At Months 0, 6, 7, 12, 18 and 24 | Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). |
| Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | Up to Month 24 | HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6. |
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | Within 30 days after any vaccination | Unsolicited AE covers any AE 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 Reporting Serious Adverse Events (SAE) | Throughout the study period (up to Month 24) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | Throughout the study period (up to Month 24) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Outcome of Any Reported Pregnancies | Throughout the study period (up to Month 24) | Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below. |
| Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | At Month 0 and Month 7 | Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined. |
| Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | At Month 0 and Month 7 | Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined. Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH). |
| Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | At Month 0 and Month 7 | Abnormalities in concentrations (expressed as milligrams per deciliter \[mg/dL\]) are presented categorical as follows: Protein: \<10 (-)\*; 10-25 (+-)\*; 25-85 (+); 85-250 (2+); 250-800 (3+). Glucose: \<30 (-)\*; 30-60 (+-)\*; 60-125 (+); 125-250 (2+); 250-750 (3+). Urobilinogen: \<1.5 (+-)\*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+). Bilirubin: \<0.35 (-)\*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+). Occult blood: \<0.015 (-)\*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); \>0.75 (3+). Ketone body: \<2.5 (-)\*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+). Normal ranges indicated by asterix\*. |
| Number of Subjects Reporting Solicited Local and General Symptoms | Within 7 days after each and any vaccination | Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. |
Countries
Japan
Participant flow
Pre-assignment details
Six subjects enrolled in this study were not vaccinated and hence not reported as started in the participant flow table below.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule. | 519 |
| Aimmugen Group Subjects received 3 doses of Aimmugen™ (Hepatitis A \[HAV\] vaccine) according to a 0, 1, 6-month schedule. | 521 |
| Total | 1,040 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 1 |
| Overall Study | Lost to Follow-up | 26 | 34 |
| Overall Study | Other | 38 | 44 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | Cervarix Group | Aimmugen Group | Total |
|---|---|---|---|
| Age, Continuous | 22.4 years STANDARD_DEVIATION 1.7 | 22.5 years STANDARD_DEVIATION 1.6 | 22.5 years STANDARD_DEVIATION 1.6 |
| Race/Ethnicity, Customized Asian - Japanese heritage | 519 Participants | 521 Participants | 1040 Participants |
| Sex: Female, Male Female | 519 Participants | 521 Participants | 1040 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 | 1 / 519 | 0 / 521 |
| other Total, other adverse events | 512 / 519 | 459 / 521 |
| serious Total, serious adverse events | 18 / 519 | 19 / 521 |
Outcome results
Primary
Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
Persistent HPV-16 or HPV-18 infection is defined as at least 2 positive Human Papillomavirus (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 approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6\].
Time frame: Throughout the study period (up to Month 24)
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16/18 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-18 | 0 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16/18 | 15 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16 | 11 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-18 | 5 Participants |
Secondary
Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples
Abnormalities in concentrations (expressed as milligrams per deciliter \[mg/dL\]) are presented categorical as follows: Protein: \<10 (-)\*; 10-25 (+-)\*; 25-85 (+); 85-250 (2+); 250-800 (3+). Glucose: \<30 (-)\*; 30-60 (+-)\*; 60-125 (+); 125-250 (2+); 250-750 (3+). Urobilinogen: \<1.5 (+-)\*; 1.5-3.5 (+); 3.5-7 (2+); 7-14 (3+). Bilirubin: \<0.35 (-)\*; 0.35-1.5 (+); 1.5-5 (2+); 5-12 (3+). Occult blood: \<0.015 (-)\*; 0.015-0.045 (+-); 0.045-015 (+); 0.15-0.75 (2+); \>0.75 (3+). Ketone body: \<2.5 (-)\*; 2.5-7.5 (+-); 7.5-30 (+); 30-70 (2+); 70-125 (3+). Normal ranges indicated by asterix\*.
Time frame: At Month 0 and Month 7
Population: Analysis was performed on the Total Vaccinated cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (Unknown) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (-) [Month 0] | 483 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+-) [Month 7] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+-) [Month 0] | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (3+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+) [Month 0] | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+) [Month 7] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (2+) [Month 0] | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (2+) [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (3+) [Month 0] | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (2+) [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (Unknown) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (Unknown) [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (-) [Month 7] | 393 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (3+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+-) [Month 7] | 22 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (-) [Month 7] | 444 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+) [Month 7] | 19 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (Unknown) [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (2+) [Month 7] | 22 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (-) [Month 0] | 513 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (3+) [Month 7] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (-) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (Unknown) [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+) [Month 0] | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (-) [Month 0] | 501 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+-) [Month 0] | 506 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+-) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+-) [Month 0] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+) [Month 0] | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+) [Month 0] | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (2+) [Month 0] | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+-) [Month 7] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (3+) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (2+) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (Unknown) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (-) [Month 7] | 452 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (3+) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+-) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (3+) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+) [Month 7] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (2+) [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (Unknown) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (3+) [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (2+) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (Unknown) [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+) [Month 7] | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (-) [Month 0] | 517 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (-) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+-) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (3+) [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+-) [Month 7] | 460 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (2+) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+-) [Month 0] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (3+) [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+) [Month 7] | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (Unknown) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (Unknown) [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (-) [Month 7] | 466 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (2+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+-) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (2+) [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (3+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (2+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (-) [Month 7] | 459 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (3+) [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (Unknown) [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (Unknown) [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (-) [Month 0] | 496 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (Unknown) [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (-) [Month 0] | 492 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+-) [Month 0] | 11 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+) [Month 0] | 16 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (2+) [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (3+) [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (Unknown) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (-) [Month 7] | 448 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+-) [Month 7] | 11 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (+) [Month 7] | 14 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (2+) [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (3+) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Protein (Unknown) [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (-) [Month 0] | 520 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+-) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (2+) [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (3+) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (Unknown) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (-) [Month 7] | 471 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+-) [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (+) [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (2+) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (3+) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Glucose (Unknown) [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (-) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+-) [Month 0] | 502 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+) [Month 0] | 15 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (2+) [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (3+) [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (Unknown) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+) [Month 7] | 10 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (-) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+-) [Month 7] | 460 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (+) [Month 7] | 12 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (2+) [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (3+) [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Urobilinogen (Unknown) [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (-) [Month 0] | 495 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+-) [Month 0] | 7 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+) [Month 0] | 9 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (2+) [Month 0] | 8 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (3+) [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (Unknown) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (-) [Month 7] | 398 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+-) [Month 7] | 28 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (+) [Month 7] | 20 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (2+) [Month 7] | 18 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (3+) [Month 7] | 10 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Occult Blood (Unknown) [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (-) [Month 0] | 506 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+-) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+) [Month 0] | 8 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (2+) [Month 0] | 6 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (3+) [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (Unknown) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (-) [Month 7] | 460 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (+-) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (2+) [Month 7] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (3+) [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Ketone Body (Unknown) [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (-) [Month 0] | 520 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+-) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+) [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (2+) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (3+) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (Unknown) [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (-) [Month 7] | 474 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+-) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (+) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (2+) [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Abnormal Biochemical Parameters in Urine Samples | Bilirubin (3+) [Month 7] | 0 Participants |
Secondary
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters
Biochemical parameters were assessed in blood samples. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined. Abbreviations: aminotransferase (ALT), aspartate aminotransferase (ASP), C reactive protein (CRP), gamma-glutamyl-transferase (GGT) and lactate dehydrogenase (LDH).
Time frame: At Month 0 and Month 7
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Above [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Normal [Month 0] | 519 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Above [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Normal [Month 7] | 466 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Above [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Below [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Normal [Month 0] | 483 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Above [Month 0] | 20 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Below [Month 0] | 16 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Normal [Month 7] | 421 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Above [Month 7] | 30 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Below [Month 7] | 16 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Normal [Month 0] | 500 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Above [Month 0] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Below [Month 0] | 16 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Normal [Month 7] | 451 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Above [Month 7] | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Below [Month 7] | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Normal [Month 0] | 510 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Above [Month 0] | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Below [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Normal [Month 7] | 457 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Above [Month 7] | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Below [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Normal [Month 0] | 516 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Above [Month 0] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Normal [Month 7] | 464 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Above [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Normal [Month 0] | 450 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Above [Month 0] | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Below [Month 0] | 62 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Normal [Month 7] | 417 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Above [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Below [Month 7] | 47 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Normal [Month 0] | 516 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Above [Month 0] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Normal [Month 7] | 461 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Above [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Below [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Normal [Month 0] | 407 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Above [Month 0] | 42 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Below [Month 0] | 70 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Normal [Month 7] | 355 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Above [Month 7] | 36 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Below [Month 7] | 76 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Normal [Month 0] | 518 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Below [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Normal [Month 7] | 466 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Above [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Below [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Normal [Month 0] | 456 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Above [Month 0] | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Below [Month 0] | 50 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Normal [Month 7] | 412 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Above [Month 7] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Below [Month 7] | 45 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Normal [Month 0] | 510 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Above [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Below [Month 0] | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Normal [Month 7] | 453 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Above [Month 7] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Below [Month 7] | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Normal [Month 0] | 500 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Above [Month 0] | 19 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Normal [Month 7] | 457 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Above [Month 7] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Normal [Month 0] | 510 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Above [Month 0] | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Normal [Month 7] | 459 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Above [Month 7] | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Normal [Month 0] | 468 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Above [Month 0] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Below [Month 0] | 41 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Normal [Month 7] | 409 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Above [Month 7] | 15 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Below [Month 7] | 43 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Normal [Month 0] | 509 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Above [Month 0] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Normal [Month 7] | 462 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Above [Month 7] | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Normal [Month 0] | 510 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Above [Month 0] | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Below [Month 0] | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Normal [Month 7] | 460 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Above [Month 7] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Below [Month 7] | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Normal [Month 0] | 486 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Above [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Below [Month 0] | 31 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Normal [Month 7] | 433 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Above [Month 7] | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Below [Month 7] | 29 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Normal [Month 0] | 519 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Above [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Normal [Month 7] | 466 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Above [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Normal [Month 0] | 472 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Above [Month 0] | 47 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Normal [Month 7] | 440 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Above [Month 7] | 27 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Normal [Month 0] | 318 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Above [Month 0] | 24 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Below [Month 0] | 177 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Normal [Month 7] | 275 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Above [Month 7] | 28 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Below [Month 7] | 164 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Normal [Month 0] | 510 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Above [Month 0] | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Below [Month 0] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Normal [Month 7] | 454 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Above [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Below [Month 7] | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Normal [Month 0] | 515 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Above [Month 0] | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Unknown [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Normal [Month 7] | 465 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Above [Month 7] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Normal [Month 0] | 466 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Above [Month 0] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Normal [Month 7] | 438 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Above [Month 7] | 28 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Unknown [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Normal [Month 0] | 106 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Above [Month 0] | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Unknown [Month 0] | 401 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Normal [Month 7] | 126 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Above [Month 7] | 20 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Below [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Unknown [Month 7] | 373 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Normal [Month 0] | 515 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Normal [Month 0] | 521 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Normal [Month 0] | 466 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Above [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Above [Month 0] | 6 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Normal [Month 0] | 520 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Normal [Month 7] | 472 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Above [Month 0] | 55 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Above [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Below [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Normal [Month 7] | 442 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Normal [Month 7] | 471 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Normal [Month 0] | 488 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Above [Month 0] | 20 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Above [Month 7] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Normal [Month 0] | 518 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Below [Month 0] | 13 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Above [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Normal [Month 7] | 443 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Above [Month 7] | 19 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | GGT Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Below [Month 7] | 12 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Albumin/Globulin ratio Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Normal [Month 0] | 464 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Normal [Month 0] | 497 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Normal [Month 7] | 443 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Above [Month 0] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Above [Month 0] | 11 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Below [Month 0] | 20 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Below [Month 0] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Normal [Month 7] | 453 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Above [Month 7] | 31 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Above [Month 7] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Below [Month 7] | 18 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Above [Month 7] | 32 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Alkaline phosphatase Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Normal [Month 7] | 423 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Above [Month 0] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Above [Month 7] | 18 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Below [Month 7] | 34 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Normal [Month 7] | 471 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total bilirubin Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Above [Month 7] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Glucose Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Above [Month 7] | 16 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | ALT Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Normal [Month 0] | 509 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Normal [Month 0] | 520 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Normal [Month 0] | 324 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Above [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Above [Month 0] | 11 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Normal [Month 7] | 473 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Below [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Normal [Month 7] | 472 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Above [Month 0] | 21 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Above [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Below [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | AST Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Normal [Month 7] | 470 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Normal [Month 0] | 466 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Below [Month 0] | 176 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Above [Month 0] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Above [Month 7] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Below [Month 0] | 52 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Above [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Normal [Month 7] | 434 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Above [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Potassium Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Below [Month 7] | 39 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Unknown [Month 0] | 440 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Blood Urea Nitrogen Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Normal [Month 0] | 512 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Normal [Month 0] | 519 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Normal [Month 7] | 290 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Above [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Above [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Below [Month 0] | 8 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Normal [Month 7] | 468 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Above [Month 7] | 26 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Above [Month 7] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Below [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Calcium Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Normal [Month 7] | 462 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Normal [Month 0] | 402 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Below [Month 7] | 158 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Above [Month 7] | 9 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Above [Month 0] | 34 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Uric acid Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Below [Month 0] | 85 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Below [Month 7] | 3 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Triglycerides Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Normal [Month 7] | 367 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Leucine Amino Peptidase Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Above [Month 7] | 36 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Unknown [Month 7] | 409 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Below [Month 7] | 71 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Normal [Month 0] | 491 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total cholesterol Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Normal [Month 0] | 509 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Normal [Month 0] | 518 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Above [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Above [Month 0] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Below [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Normal [Month 0] | 462 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Below [Month 0] | 29 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Normal [Month 7] | 472 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Above [Month 0] | 10 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Above [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Below [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Normal [Month 0] | 70 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Chlorine Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Normal [Month 7] | 437 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Normal [Month 0] | 454 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Below [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Above [Month 0] | 13 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Above [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Below [Month 0] | 54 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Above [Month 0] | 59 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Normal [Month 7] | 420 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Below [Month 7] | 35 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Above [Month 7] | 7 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Below [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | LDH Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine phosphokinase Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Normal [Month 7] | 96 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Normal [Month 0] | 509 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Normal [Month 0] | 521 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Above [Month 0] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Normal [Month 7] | 463 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Below [Month 0] | 8 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Above [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Normal [Month 7] | 466 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Above [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Above [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Below [Month 7] | 6 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Creatinine Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | CRP Above [Month 0] | 11 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Normal [Month 0] | 494 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Normal [Month 7] | 474 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Above [Month 0] | 27 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Below [Month 7] | 9 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Below [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Above [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | pH Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Normal [Month 7] | 458 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Above [Month 7] | 16 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Total protein Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Below [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Sodium Unknown [Month 7] | 47 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical Parameters | Direct bilirubin Unknown [Month 7] | 47 Participants |
Secondary
Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters
Hematological parameters assessed in blood samples include hemoglobin, haematocrit, mean corpuscular (MC) hemoglobin, mean corpuscular (MC) hemoglobin concentration, mean corpuscular (MC) volume, platelet count, red blood cell count, white blood cell count. Abnormalities reported include values outside the normal ranges: values higher than normal are designated as Above and values lower than normal as Below while Unknown stands for values not determined.
Time frame: At Month 0 and Month 7
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Normal [Month 0] | 504 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Above [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Below [Month 0] | 18 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Normal [Month 7] | 448 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Above [Month 7] | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Below [Month 7] | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Normal [Month 0] | 501 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Above [Month 0] | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Below [Month 0] | 14 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Normal [Month 7] | 448 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Above [Month 7] | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Below [Month 7] | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Normal [Month 0] | 499 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Above [Month 0] | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Below [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Unknown [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Normal [Month 7] | 456 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Above [Month 7] | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Below [Month 7] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Unknown [Month 7] | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Normal [Month 0] | 514 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Above [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Below [Month 0] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Normal [Month 7] | 457 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Above [Month 7] | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Below [Month 7] | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Normal [Month 0] | 496 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Above [Month 0] | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Below [Month 0] | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Normal [Month 7] | 440 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Above [Month 7] | 23 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Below [Month 7] | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Normal [Month 0] | 489 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Above [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Below [Month 0] | 29 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Normal [Month 7] | 441 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Above [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Below [Month 7] | 26 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Normal [Month 0] | 495 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Above [Month 0] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Below [Month 0] | 23 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Normal [Month 7] | 442 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Above [Month 7] | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Below [Month 7] | 25 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Unknown [Month 7] | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Normal [Month 0] | 504 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Above [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Below [Month 0] | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Unknown [Month 0] | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Normal [Month 7] | 457 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Above [Month 7] | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Below [Month 7] | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Unknown [Month 7] | 52 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Normal [Month 0] | 498 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Normal [Month 0] | 499 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Above [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Normal [Month 0] | 488 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Below [Month 0] | 21 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Above [Month 0] | 14 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Normal [Month 0] | 505 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Normal [Month 7] | 444 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Below [Month 0] | 8 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Above [Month 7] | 7 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Above [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Below [Month 7] | 22 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hemoglobin Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Normal [Month 7] | 456 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Normal [Month 0] | 506 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Normal [Month 7] | 453 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Above [Month 0] | 5 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Below [Month 0] | 33 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Below [Month 0] | 10 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Above [Month 7] | 16 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Above [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Normal [Month 7] | 456 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Below [Month 7] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Above [Month 7] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Below [Month 7] | 13 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | White Blood Cells count Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Hematocrit Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Below [Month 7] | 16 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Normal [Month 0] | 514 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Normal [Month 0] | 491 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Above [Month 0] | 5 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Normal [Month 7] | 434 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Below [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Above [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Below [Month 0] | 16 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Normal [Month 7] | 461 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Below [Month 0] | 30 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Above [Month 7] | 10 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Above [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Below [Month 7] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Platelet count Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Above [Month 7] | 1 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Normal [Month 0] | 515 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Normal [Month 7] | 439 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Above [Month 0] | 4 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Below [Month 7] | 39 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Below [Month 0] | 2 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Above [Month 7] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC volume Unknown [Month 0] | 0 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Normal [Month 7] | 463 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Below [Month 7] | 34 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Above [Month 7] | 5 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin concentration Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Below [Month 7] | 5 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | MC hemoglobin Unknown [Month 7] | 48 Participants |
| Aimmugen Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Hematological Parameters | Red Blood Cells count Unknown [Month 7] | 48 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. MSC include adverse events (AEs) prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases. Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: Throughout the study period (up to Month 24)
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs | 5 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs | 91 Participants |
| Aimmugen Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | NOCDs | 6 Participants |
| Aimmugen Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions (MSCs) | MSCs | 107 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAE)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (up to Month 24)
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 18 Participants |
| Aimmugen Group | Number of Subjects Reporting Serious Adverse Events (SAE) | 19 Participants |
Secondary
Number of Subjects Reporting Solicited Local and General Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include arthralgia, fatigue, fever (above 37.5 degree Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria.
Time frame: Within 7 days after each and any vaccination
Population: Analysis was performed on the Total Vaccinated Cohort, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 508 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Gastro-intestinal symptoms | 172 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 401 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache | 250 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 41 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Myalgia | 262 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia | 123 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Rash | 33 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 455 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Urticaria | 16 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue | 341 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Urticaria | 20 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Pain | 214 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Redness | 287 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Swelling | 165 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Arthralgia | 61 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fever | 28 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Gastro-intestinal symptoms | 167 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Headache | 222 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Myalgia | 128 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Rash | 24 Participants |
| Aimmugen Group | Number of Subjects Reporting Solicited Local and General Symptoms | Fatigue | 300 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Unsolicited AE covers any AE 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 30 days after any vaccination
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 294 Participants |
| Aimmugen Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 266 Participants |
Secondary
Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value
Anti-HPV-16 antibody cut-off value assessed include 8 ELISA units per milliliter (EL.U/mL) and anti-HPV-18 antibody cut-off value assessed include 7 EL.U/mL.
Time frame: At Months 0 (pre-vaccination), 6, 7, 12, 18 and 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (pre-vaccination) | 64 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 6) | 411 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 7) | 410 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 12) | 373 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 18) | 356 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 24) | 351 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (pre-vaccination) | 61 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 6) | 410 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 7) | 409 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 12) | 372 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 18) | 355 Participants |
| Cervarix Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 24) | 350 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 18) | 40 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (pre-vaccination) | 51 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (pre-vaccination) | 48 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 6) | 55 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 12) | 55 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 7) | 52 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 6) | 53 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 12) | 46 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 24) | 38 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 18) | 39 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-18 (Month 7) | 54 Participants |
| Aimmugen Group | Number of Subjects With Anti-human Papillomavirus 16 and 18 (Anti-HPV-16 and Anti-HPV-18) Antibody Titers Above the Cut-off Value | HPV-16 (Month 24) | 38 Participants |
Secondary
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Cytologically-confirmed abnormalities assessed include ASC-US, LSIL, HSIL, ASC-H and AGC. These cytological abnormalities were assessed in women who were, for the corresponding HPV type (determined by PCR), HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-16 | 0 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-18 | 1 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-31 | 2 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-33 | 1 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-35 | 2 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-39 | 3 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-45 | 0 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-51 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-52 | 6 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-56 | 5 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-58 | 4 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-59 | 3 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-66 | 1 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-68 | 3 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types except HPV-16/18 | 23 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types | 24 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types | 42 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-16 | 9 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-52 | 7 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-18 | 4 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-66 | 3 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-31 | 0 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-56 | 6 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-33 | 2 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types except HPV-16/18 | 35 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-35 | 1 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-58 | 10 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-39 | 5 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-68 | 5 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-45 | 0 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-59 | 3 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-51 | 5 Participants |
Secondary
Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection
Cytologically-confirmed abnormalities assessed include atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), atypical squamous cells-can not exclude HSIL (ASC-H) and atypical glandular cells (AGC). These cytological abnormalities were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | HPV-16/18 | 1 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | HPV-16 | 0 Participants |
| Cervarix Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | HPV-18 | 1 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | HPV-16/18 | 12 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | HPV-16 | 8 Participants |
| Aimmugen Group | Number of Subjects With Cytologically-confirmed Abnormalities Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus 18 (HPV-18) Cervical Infection | HPV-18 | 4 Participants |
Secondary
Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type
Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding HPV type (determined by polymerase chain reaction)), HPV deoxyribonucleic acid (DNA) negative at Month 0 and Month 6. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-16 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-31 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-33 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-35 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-39 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-45 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-51 | 2 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-52 | 3 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-56 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-58 | 1 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-59 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-66 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-68 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types except HPV-16/18 | 6 Participants |
| Cervarix Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types | 6 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types | 17 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-16 | 3 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-52 | 5 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-18 | 1 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-66 | 0 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-31 | 0 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-56 | 0 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-33 | 1 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | Any HR HPV types except HPV-16/18 | 14 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-35 | 0 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-58 | 5 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-39 | 1 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-68 | 2 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-45 | 0 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-59 | 1 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically Confirmed Lesions Concurrently Associated With Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Type | HPV-51 | 2 Participants |
Secondary
Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection
Histopathologically-confirmed lesions assessed include cervical intraepithelial neoplasia of grade 1 (CIN1), grade 2 (CIN2), grade 3 (CIN3) and adenocarcinoma. These lesions were assessed in women who were, for the corresponding Human Papillomavirus (HPV) type, seronegative at Month 0 and HPV deoxyribonucleic acid (DNA) negative (by polymerase chain reaction) at Month 0 and Month 6.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | HPV-16/18 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | HPV-16 | 0 Participants |
| Cervarix Group | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | HPV-18 | 0 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | HPV-16/18 | 3 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | HPV-16 | 2 Participants |
| Aimmugen Group | Number of Subjects With Histopathologically-confirmed Lesions Concurrently Associated With Human Papillomavirus 16 (HPV-16) and/or Human Papillomavirus (HPV-18) Cervical Infection | HPV-18 | 1 Participants |
Secondary
Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Incident infection for oncogenic HPV types is defined as at least one positive oncogenic HPV type deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-58 | 12 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-18 | 4 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types except HPV-16/18 | 90 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-31 | 8 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-66 | 6 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-33 | 2 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-35 | 7 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types | 98 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-39 | 13 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-59 | 8 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-45 | 0 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-68 | 8 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-51 | 14 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-16 | 5 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-52 | 30 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-56 | 15 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-52 | 32 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-56 | 15 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-58 | 13 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-59 | 5 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-66 | 13 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-68 | 12 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types except HPV-16/18 | 113 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types | 134 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-33 | 5 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-16 | 24 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-18 | 20 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-31 | 7 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-35 | 4 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-39 | 14 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-45 | 0 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-51 | 29 Participants |
Secondary
Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18)
HPV-16 or HPV-18 incident infection is defined as at least one positive HPV-16 or HPV-18 deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) assay in women who were, for the corresponding HPV type, seronegative at Month 0 and HPV DNA negative (by PCR) at Month 0 and Month 6.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16/18 | 7 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16 | 4 Participants |
| Cervarix Group | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-18 | 3 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16/18 | 39 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-16 | 22 Participants |
| Aimmugen Group | Number of Subjects With Incident Cervical Infection With Human Papillomavirus 16 (HPV-16) or Human Papillomavirus 18 (HPV-18) | HPV-18 | 18 Participants |
Secondary
Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types
Persistent infection for oncogenic HPV types is defined as 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 approximate interval of 6 months (\> 150 days) \[as assessed in women who were, for the corresponding HPV type, HPV DNA negative (by PCR) at Month 0 and Month 6\]. Oncogenic (high risk \[HR\]) HPV types assessed include HPV-16, -18, -31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66 and -68.
Time frame: Up to Month 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for efficacy, on subjects with available data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-16 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-18 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-31 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-33 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-35 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-39 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-45 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-51 | 5 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-52 | 11 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-56 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-58 | 4 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-59 | 1 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-66 | 0 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-68 | 2 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types except HPV-16/18 | 27 Participants |
| Cervarix Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types | 27 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types | 53 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-16 | 12 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-52 | 5 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-18 | 5 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-66 | 3 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-31 | 2 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-56 | 7 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-33 | 2 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | Any HR HPV types except HPV-16/18 | 39 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-35 | 1 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-58 | 8 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-39 | 4 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-68 | 1 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-45 | 0 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-59 | 0 Participants |
| Aimmugen Group | Number of Subjects With Persistent Cervical Infection With Any Oncogenic Human Papillomavirus (HPV) Types | HPV-51 | 10 Participants |
Secondary
Outcome of Any Reported Pregnancies
Information on any subject who became pregnant while participating in this study was collected. The outcomes of the pregnancies are reported below.
Time frame: Throughout the study period (up to Month 24)
Population: Analysis was performed on those subjects reporting pregnancy during the study period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Outcome of Any Reported Pregnancies | Normal infant | 20 Participants |
| Cervarix Group | Outcome of Any Reported Pregnancies | Premature birth | 1 Participants |
| Cervarix Group | Outcome of Any Reported Pregnancies | Elective termination | 14 Participants |
| Cervarix Group | Outcome of Any Reported Pregnancies | Spontaneous abortion | 5 Participants |
| Cervarix Group | Outcome of Any Reported Pregnancies | Lost to follow-up | 1 Participants |
| Cervarix Group | Outcome of Any Reported Pregnancies | Pregnancy ongoing | 5 Participants |
| Aimmugen Group | Outcome of Any Reported Pregnancies | Lost to follow-up | 0 Participants |
| Aimmugen Group | Outcome of Any Reported Pregnancies | Normal infant | 19 Participants |
| Aimmugen Group | Outcome of Any Reported Pregnancies | Spontaneous abortion | 3 Participants |
| Aimmugen Group | Outcome of Any Reported Pregnancies | Premature birth | 0 Participants |
| Aimmugen Group | Outcome of Any Reported Pregnancies | Pregnancy ongoing | 5 Participants |
| Aimmugen Group | Outcome of Any Reported Pregnancies | Elective termination | 16 Participants |
Secondary
Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Titers are given as Geometric Mean Titers (GMTs) expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: At Months 0, 6, 7, 12, 18 and 24
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 0) | 5.5 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 6) | 708.4 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 7) | 7441.0 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 12) | 2877.7 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 18) | 1864.8 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 24) | 1532.2 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 0) | 4.5 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 6) | 504.6 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 7) | 3805.4 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 12) | 1330.7 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 18) | 782.0 EL.U/mL |
| Cervarix Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 24) | 627.8 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 18) | 4.4 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 0) | 5.3 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 0) | 4.4 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 6) | 5.4 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 12) | 4.5 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 7) | 5.3 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 6) | 4.4 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 12) | 5.3 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 24) | 4.4 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 18) | 5.3 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 (Month 7) | 4.5 EL.U/mL |
| Aimmugen Group | Titers of Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 (Month 24) | 5.4 EL.U/mL |