Infections, Papillomavirus
Conditions
Keywords
Human Papillomavirus (HPV) vaccine, safety, cervical cancer, immunogenicity, vaccine, viral infections, pre-adolescent and adolescent females
Brief summary
Human papillomavirus (HPV) infection has been established as a necessary cause of cervical cancer. GSK Biologicals has developed an HPV vaccine (580299) which targets the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all cervical cancers. In previous trials, the vaccine has been found to be efficacious in the prevention of incident and persistent HPV-16/18 infections and associated cytological abnormalities. HPV vaccination should ideally be performed before onset of sexual activity. Previous studies showed that GSK Biologicals' HPV vaccine 580299 is safe and immunogenic when administered to European, Asian, Latin American and Australian pre-adolescents and adolescents. Here, we aim to assess the immunogenicity and safety of the GSK Biologicals' HPV vaccine 580299 in healthy Japanese pre-adolescent and adolescent female subjects aged 10-15 years. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALCervarix™ (HPV-16/18 L1 VLP AS04)
Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator/co-investigator believes that they and/or their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol should be enrolled in the study. * A Japanese female between, and including, 10 and 15 years of age at the time of the first vaccination. * Written informed consent obtained from the parent(s) or legally acceptable representative(s) of the subject. In addition, a written informed assent must be obtained from the subject prior to enrolment. * Healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * All subjects must have a negative urine pregnancy test. * Subjects must be of non-childbearing potential, or, if of childbearing potential, they must be abstinent or have used adequate contraception 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. Non-abstinent pre-menarche subjects, as well as subjects who reach menarche during study, must follow the same precautions.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during study. * 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. Administration of vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window. * Concurrently participating in another clinical study, at any time during the study period (up to Month 7), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period (Day 0 to Month 7). * Previous administration of components of the investigational vaccine . * Cancer or autoimmune disease under treatment. * 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 vaccine. * Hypersensitivity to latex. * Acute disease at the time of enrolment. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or breastfeeding subject. * Subject planning to become pregnant or planning to discontinue contraceptive precautions. * Oral temperature ≥ 37.5°C/Axillary temperature ≥ 37.5°C.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | One month post Dose 3 (Month 7) | Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Titers | Before vaccination (PRE) and one month post Dose 3 (Month 7) | Titers are given as geometric mean titers (GMTs) calculated on all subjects. |
| Number of Subjects Reporting Solicited Local Symptoms | During the 7-day (Days 0-6) period following each vaccination | Solicited local symptoms assessed include pain, redness and swelling. |
| Number of Subjects Reporting Solicited General Symptoms | During the 7-day (Days 0-6) period following each vaccination | Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AE) | During the 30-day (Days 0-29) period following each vaccination | Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. |
| Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | At Day 0 and Month 7 | Abnormalities include values outside (above or below) the normal ranges. Normal ranges: alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL |
| Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | From Day 0 up to Month 7 | NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses. |
| Outcome of All Pregnancies | Up to Month 7 | According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | From Day 0 up to Month 7 | Serious adverse events 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Cervarix Group |
|---|---|
| Age, Continuous | 12.1 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 100 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Anti-HPV-16 and Anti-HPV-18 Antibody Titers
Titers are given as geometric mean titers (GMTs) calculated on all subjects.
Time frame: Before vaccination (PRE) and one month post Dose 3 (Month 7)
Population: Analysis was performed on the ATP cohort for immunogenicity.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers | Anti-HPV-16 (PRE) | 4.4 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers | Anti-HPV-16 (Month 7) | 19748.0 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers | Anti-HPV-18 (PRE) | 3.7 titer |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Titers | Anti-HPV-18 (Month 7) | 8765.3 titer |
Primary
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash, and urticaria.
Time frame: During the 7-day (Days 0-6) period following each vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Arthralgia | 15 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fatigue | 40 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Fever | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Gastrointestinal symptoms | 17 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Headache | 33 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Myalgia | 26 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Rash | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Urticaria | 3 Participants |
Primary
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling.
Time frame: During the 7-day (Days 0-6) period following each vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Pain | 98 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Redness | 85 Participants |
| Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Swelling | 81 Participants |
Primary
Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies
Seroconversion is defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e. antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination. Cut-off values were 8 enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Time frame: One month post Dose 3 (Month 7)
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 Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-16 | 92 Participants |
| Cervarix Group | Number of Subjects Seroconverted for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies | Anti-HPV-18 | 94 Participants |
Secondary
Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Abnormalities include values outside (above or below) the normal ranges. Normal ranges: alanine aminotransferase (ALT): 5-35 U/L aspartate aminotransferase (AST): 5-50 U/L basophils: 0-2 % bilirubin total: 0.1-1.1 mg/dL blood urea nitrogen: 0-20 mg/dL creatinine: 0.2-1.2 mg/dL eosinophils: 0-7 % hematocrit: 30-45 % hemoglobin: 10-15 g/dL lymphocytes: 18-50 % monocytes: 1-8 % neutrophils: 42-74 % platelets: 10-60 10E4/microL red blood cells: 350-550 10E4/microL total protein: 6.5-8.6 g/dL white blood cells: 4000-15000 /microL
Time frame: At Day 0 and Month 7
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above (Day 0) | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | ALT Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | AST Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | AST Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | AST Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | AST Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Basophils Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Basophils Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Basophils Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Basophils Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Blood urea nitrogen Above (Day 0) | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Blood urea nitrogen Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Blood urea nitrogen Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Blood urea nitrogen Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Creatinine Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Creatinine Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Creatinine Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Creatinine Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Eosinophils Above (Day 0) | 17 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Eosinophils Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Eosinophils Above (Month 7) | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Eosinophils Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hematocrit Above (Day 0) | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hematocrit Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hematocrit Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hemoglobin Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hemoglobin Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hemoglobin Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Lymphocytes Above (Day 0) | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Lymphocytes Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Lymphocytes Above (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Lymphocytes Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Monocytes Above (Day 0) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Monocytes Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Monocytes Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Neutrophils Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Neutrophils Below (Day 0) | 21 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Neutrophils Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Neutrophils Below (Month 7) | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Platelets Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Platelets Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Platelets Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Red blood cells Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Red blood cells Below (Day 0) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Red blood cells Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Red blood cells Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total protein Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total protein Below (Day 0) | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total protein Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total protein Below (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total bilirubin Above (Day 0) | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total bilirubin Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total bilirubin Above (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Total bilirubin Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | White blood cells Above (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | White blood cells Below (Day 0) | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | White blood cells Below (Month 7) | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Monocytes Above (Month 7) | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Platelets Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | White blood cells Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hematocrit Below (Day 0) | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Clinically Relevant Abnormalities in Biochemical and Haematological Parameters | Hemoglobin Above (Month 7) | 1 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
NOCDs assessed include e.g. autoimmune disorders, asthma, type I diabetes. Medically significant conditions assessed include adverse events prompting emergency room visits and physician office visits not related to common illnesses or Serious Adverse Events that are not related to common illnesses.
Time frame: From Day 0 up to Month 7
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | NOCDs | 0 Participants |
| Cervarix Group | Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions | Medically significant conditions | 18 Participants |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
Serious adverse events 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: From Day 0 up to Month 7
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Unsolicited adverse event= Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: During the 30-day (Days 0-29) period following each vaccination
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Unsolicited Adverse Events (AE) | 63 Participants |
Secondary
Outcome of All Pregnancies
According to the study protocol, the outcome of all pregnancies reported during the entire study period was to be reported, even if delivery occurs after the end of the study.
Time frame: Up to Month 7
Population: There were no pregnancies reported between Day 0 and Month 7 in the Total Vaccinated Cohort.