Infections, Papillomavirus
Conditions
Keywords
Immunogenicity, Safety, Human papillomavirus, China, HPV vaccine
Brief summary
This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.
Interventions
BIOLOGICALCervarixTM
Subjects will receive three doses of the Cervarix vaccine intramuscularly according to a 0, 1, 6-month schedule.
OTHERControl
Subjects will receive three doses of control intramuscularly according to a 0, 1, 6-month schedule.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they or their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol. * Healthy Chinese females between and including 9 and 17 years of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment. * Healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * Subjects must not be pregnant. Absence of pregnancy will be verified with a urine pregnancy test before each vaccination. * Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and agree to continue such precautions for 2 months after completion of the vaccination series.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after (i.e., Days 0-29) the first dose of vaccine. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * Pregnant or breastfeeding. Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study. * Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the protocol during the study period. * Previous administration of components of the study vaccine. * History of chronic condition(s) requiring treatment such as cancer or autoimmune disease. * History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | One month after the third dose (at Month 7) | Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 7 days (Days 0 - 6) following each vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm). |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 7 days (Days 0 - 6) following each vaccination | Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Medically Significant Conditions (MSCs) | Throughout the study period (from Day 0 up to Month 12) | Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) 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, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. MSCs were collected regardless of causal relationship to vaccination and intensity. |
| Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | At 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days (Days 0 - 29) 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Throughout the study period (from Day 0 up to Month 12) | 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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Pregnancies and Pregnancy Outcomes | Throughout the study period (from Day 0 up to Month 12) | — |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. | 374 |
| Placebo Group Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule. | 376 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Cervarix Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 13.1 Years STANDARD_DEVIATION 2.44 | 13.1 Years STANDARD_DEVIATION 2.42 | 13.1 Years STANDARD_DEVIATION 2.43 |
| Sex: Female, Male Female | 374 Participants | 376 Participants | 750 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 | — / — | — / — |
| other Total, other adverse events | 360 / 374 | 339 / 376 |
| serious Total, serious adverse events | 5 / 374 | 2 / 376 |
Outcome results
Primary
Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens
Titers were given as geometric mean titers and were measured by Enzyme-linked Immunosorbent Assay (ELISA) and expressed as Enzyme-linked Immunosorbent Assay Units Per Milliliter (EL.U/mL).
Time frame: One month after the third dose (at Month 7)
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included subjects who received 3 doses of the study vaccine or placebo and for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | Anti-HPV-16 | 18347.1 EL.U/mL |
| Cervarix Group | Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | Anti-HPV-18 | 7960.2 EL.U/mL |
| Placebo Group | Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | Anti-HPV-16 | 5.0 EL.U/mL |
| Placebo Group | Geometric Mean Titers (GMTs) for Antibodies Against Human Papillomavirus (HPV)-16/18 Antigens | Anti-HPV-18 | 4.1 EL.U/mL |
Secondary
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 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Time frame: During the 7 days (Days 0 - 6) following each vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and 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 | 350 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 38 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 113 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling | 113 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 13 Participants |
| Placebo Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any swelling | 54 Participants |
| Placebo Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any pain | 299 Participants |
| Placebo Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 redness | 1 Participants |
| Placebo Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 pain | 16 Participants |
| Placebo Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 swelling | 2 Participants |
| Placebo Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any redness | 52 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: Throughout the study period (from Day 0 up to Month 12)
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
| Placebo Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 2 Participants |
| Placebo Group | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, rash, urticaria and fever (= axillary temperature above 37.0 degrees Celsius (°C). Grade 3 fever = axillary temperature above 39.0°C. Grade 3 urticaria = urticaria distributed on at least 4 body areas. For other symptoms, any = occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 = a general symptom that prevented normal activity. Related was a general symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7 days (Days 0 - 6) following each vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 25 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related myalgia | 96 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any rash | 9 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any gastrointestinal symptoms | 57 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 rash | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 137 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related rash | 3 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 gastrointestinal symptoms | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 86 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related gastrointestinal symptoms | 21 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 40 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 2 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 123 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 80 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 5 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 38 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any myalgia | 110 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any urticaria | 8 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 urticaria | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 106 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related urticaria | 7 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 myalgia | 1 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related urticaria | 1 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related myalgia | 83 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any arthralgia | 33 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 arthralgia | 2 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fatigue | 126 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fatigue | 4 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fatigue | 98 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any gastrointestinal symptoms | 45 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 gastrointestinal symptoms | 2 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 headache | 3 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related headache | 70 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any myalgia | 93 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 myalgia | 1 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any rash | 4 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 rash | 0 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related rash | 2 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any fever | 74 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 fever | 0 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related gastrointestinal symptoms | 31 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any headache | 99 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related fever | 27 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any urticaria | 3 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 urticaria | 0 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related arthralgia | 23 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: Within 30 days (Days 0 - 29) after any vaccination
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 139 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 0 Participants |
| Cervarix Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 2 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AEs | 3 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AEs | 3 Participants |
| Placebo Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AEs | 125 Participants |
Secondary
Number of Subjects Reporting Medically Significant Conditions (MSCs)
Medically significant conditions (MSCs) are defined as: adverse events (AEs) prompting emergency room or physician visits that are not (1) related to common diseases or (2) 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, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. MSCs were collected regardless of causal relationship to vaccination and intensity.
Time frame: Throughout the study period (from Day 0 up to Month 12)
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Medically Significant Conditions (MSCs) | 14 Participants |
| Placebo Group | Number of Subjects Reporting Medically Significant Conditions (MSCs) | 11 Participants |
Secondary
Number of Subjects Reporting Pregnancies and Pregnancy Outcomes
Time frame: Throughout the study period (from Day 0 up to Month 12)
Population: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects Reporting Pregnancies and Pregnancy Outcomes | 0 Participants |
| Placebo Group | Number of Subjects Reporting Pregnancies and Pregnancy Outcomes | 0 Participants |
Secondary
Number of Subjects Seroconverted for Anti-HPV-16 and 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: At Month 7
Population: Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity on initially seronegative subjects for whom data concerning immunogenicity measures were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16 | 326 Participants |
| Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18 | 336 Participants |
| Placebo Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18 | 10 Participants |
| Placebo Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16 | 8 Participants |