Human Papillomavirus Infection Leading to Cervical Cancer
Conditions
Keywords
Cervarix, Filipinos, Safety and reactogenicity, Human papillomavirus
Brief summary
The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines.
Interventions
BIOLOGICALCervarix
Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
10 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study. * A female 10 years of age and above at the time of the first vaccination. * Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject. * Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study. * Subjects of childbearing potential must not be pregnant. * Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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 non-investigational product (pharmaceutical product or device). * Pregnant or breastfeeding. * Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine. * Hypersensitivity to latex (found in syringe-tip cap and plunger). * Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests. * Cancer or autoimmune disease under treatment. * Previous vaccination against HPV or planned administration of another HPV vaccine during the study. * Acute disease at the time of enrolment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 7-day follow-up period (Days 0-6) after each dose and across doses | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm). |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 7-day follow-up period (Days 0-6) after each dose and across doses | Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0°C. |
| Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) post-vaccination period | An 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Month 7) | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination. |
Countries
Philippines
Participant flow
Recruitment details
Since this was a post-marketing study (PMS), subjects may have received one or two doses of Cervarix outside of the PMS.
Pre-assignment details
Out of 743 subjects enrolled in the study, only 596 subjects received study vaccination. The whole set of data was not cleaned for this study. Analysis was performed on subjects with cleaned data and on subjects with missing data or unresolved data queries, or both. The overall group includes both cleaned and not cleaned data.
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Healthy female subjects who received three doses of Cervarix vaccine administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule. | 596 |
| Total | 596 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 67 |
| Overall Study | Other | 24 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Unknown completion status | 21 |
| Overall Study | Withdrawal by Subject | 16 |
Baseline characteristics
| Characteristic | Cervarix Group |
|---|---|
| Age, Continuous | 32.8 Years STANDARD_DEVIATION 10.27 |
| Race/Ethnicity, Customized Chinese | 1 Participants |
| Race/Ethnicity, Customized Not specified | 1 Participants |
| Race/Ethnicity, Customized South Asian | 594 Participants |
| Sex: Female, Male Female | 596 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 596 |
| other Total, other adverse events | 443 / 596 |
| serious Total, serious adverse events | 4 / 596 |
Outcome results
Primary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).
Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 402 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 16 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 430 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 25 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 116 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 76 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 309 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 106 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 60 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 211 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 3 | 69 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 47 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 38 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Across doses | 168 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across doses | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 119 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 4 Participants |
Primary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0°C.
Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and had the symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 3 | 30 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 76 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 35 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 120 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 53 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 17 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 46 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 10 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 90 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 29 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 91 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 39 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 1 | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 1 | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 43 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 15 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 81 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 35 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 32 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 55 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 20 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 52 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 20 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 2 | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 2 | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 3 | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 57 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 28 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 12 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 15 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 39 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 3 | 30 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 3 | 13 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 3 | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 3 | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 102 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 48 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 165 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 11 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 72 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 32 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 19 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 68 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 4 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 19 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 127 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 6 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 47 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 115 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 51 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Across doses | 17 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Across doses | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Across doses | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Across doses | 14 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Across doses | 1 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Across doses | 4 Participants |
Primary
Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)
An 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. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.
Time frame: During the 30-day (Days 0-29) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 20 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 and Related AE(s) | 0 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (from Day 0 up to Month 7)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vacinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Any SAE(s) | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Grade 3 SAE(s) | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs) | Related SAE(s) | 0 Participants |