Human Papillomavirus (HPV) Infection
Conditions
Keywords
Safety, Immunogenicity, Human Papillomavirus (HPV) vaccine
Brief summary
Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries. The incidence of cervical cancer varies depending on the region of the world. Africa has some of the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7 and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8 per 100 000; Middle Africa 28.0 and 23.0 per 100 000). As in the majority of developing countries, organization of cervical cancer screening programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic vaccination could therefore clearly and efficiently decrease the incidence of cervical cancer. The current study is designed to assess the immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in Africa. Ideally, HPV vaccination should be performed before onset of sexual activity, since studies have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will therefore be performed in subjects aged 10 to 25 years of age.
Interventions
BIOLOGICALCervarix
The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
DRUGPlacebo Al(OH)3
Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
10 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parents/legally acceptable representative can and will comply with the requirements of the protocol should be enrolled in the study. * A female between, and including, 10 and 25 years of age at the time of the first vaccination. * Written or oral, signed or thumb printed or witnessed informed consent obtained from the subject prior to enrolment. For subjects below legal age of consent, written or oral, signed or thumb printed or witnessed informed consent obtained from the subject's parent or legally acceptable representative. In addition, a written or oral, signed or thumb printed and witnessed informed assent must be obtained from the subject. * Free of obvious health problems as established by medical history, clinical examination and laboratory testing before entering into the study. * Subjects must have a negative urine pregnancy test at the screening visit and at Visit 1 (Day 0). * Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening visit. * Subjects must be of non-childbearing potential, or, if of 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. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions. * Subjects must have had no more than 6 sexual partners prior to enrolment. * Subjects must be willing to undergo HIV voluntary counselling and testing and must be willing to be informed of their HIV status. Subjects below legal age of consent must also be willing to have their parent or legally acceptable representative informed of their HIV status.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12). * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned administration during the study period. * Administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. Enrolment will be deferred until the subject is outside of specified window. * Planned administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after any dose of study vaccine. * Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * Previous administration of components of the investigational vaccine. * Cancer or autoimmune disease under treatment. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection based on laboratory testing performed during the screening visit. * Hypersensitivity to latex. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine/control. * 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 testing performed at the screening visit. * History of any neurologic disorders or seizures. * 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 female. * A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose. * 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 Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | At Month 7 | A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. |
| Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | At Month 7 | Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 7 days (Day 0-6) after each dose and across doses | Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 7 days (Day 0-6) after each dose and across doses | Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days (Day 0-29) after any vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With NOCDs and Other MSCs | From Day 0 up to Month 7 and from Month 7 up to Month 12 | New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury. |
| Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | At Month 2 and Month 12 | A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. |
| Number of Subjects With Pregnancies and Their Outcomes | From Day 0 up to Month 12 | Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly. |
| Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | At Month 7 | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. |
| Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | At Month 7 | Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 up to Month 7 and from Month 7 up to Month 12 | SAEs assessed included 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. |
| GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | At Month 2 and Month 12 | Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years. |
Countries
Senegal, Tanzania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. | 450 |
| Placebo Group Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. | 226 |
| Total | 676 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 16 | 10 |
| Overall Study | Withdrawal by Subject | 16 | 11 |
Baseline characteristics
| Characteristic | Placebo Group | Total | Cervarix Group |
|---|---|---|---|
| Age, Continuous | 16.8 Years STANDARD_DEVIATION 4.16 | 16.9 Years STANDARD_DEVIATION 4.29 | 16.9 Years STANDARD_DEVIATION 4.36 |
| Race/Ethnicity, Customized African/African american | 219 Participants | 650 Participants | 431 Participants |
| Race/Ethnicity, Customized Not specified | 7 Participants | 26 Participants | 19 Participants |
| Sex: Female, Male Female | 226 Participants | 676 Participants | 450 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 450 | 0 / 226 |
| other Total, other adverse events | 433 / 450 | 216 / 226 |
| serious Total, serious adverse events | 17 / 450 | 14 / 226 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies
Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time frame: At Month 7
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 | 3653.6 EL.U/mL |
| Cervarix Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 | 6409.8 EL.U/mL |
| Cervarix Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 | 18591.3 EL.U/mL |
| Cervarix Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 | 10664.0 EL.U/mL |
| Placebo Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 | 5.3 EL.U/mL |
| Placebo Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 | 3.9 EL.U/mL |
| Placebo Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 | 4.6 EL.U/mL |
| Placebo Group | Geometric Mean Titers (GMTs) of Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 | 4.8 EL.U/mL |
Primary
Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies
A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time frame: At Month 7
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 15-25 years anti-HPV-18 | 212 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 15-25 years anti-HPV-16 | 190 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 10-14 years anti-HPV-16 | 130 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 10-14 years anti-HPV-18 | 128 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 10-14 years anti-HPV-16 | 4 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 15-25 years anti-HPV-18 | 5 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 10-14 years anti-HPV-18 | 2 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-human Papillomavirus (HPV)-16 and 18 Antibodies | 15-25 years anti-HPV-16 | 5 Participants |
Secondary
GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies
Titers were expressed as GMTs in Enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time frame: At Month 2 and Month 12
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 12 | 1422.1 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 2 | 3732.6 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 12 | 4016.2 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 12 | 2464.2 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 2 | 3016.7 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 2 | 2039.3 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 12 | 855.9 EL.U/mL |
| Cervarix Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 2 | 5340.2 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 2 | 4.6 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 2 | 4.5 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 2 | 3.9 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 2 | 4.9 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 12 | 4.6 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 12 | 4.7 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 12 | 3.7 EL.U/mL |
| Placebo Group | GMTs for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 12 | 5.6 EL.U/mL |
Secondary
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time frame: At Month 7
Population: The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 NORMAL | 7 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc.ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 NORMAL | 15 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 BELOW | 24 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 NORMAL | 137 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 BELOW | 30 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 ABOVE | 3 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 NORMAL | 216 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 7 NORMAL | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 NORMAL | 19 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 BELOW | 37 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 NORMAL | 149 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 BELOW | 10 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 NORMAL | 9 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 ABOVE | 34 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 7 NORMAL | 17 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 7 BELOW | 2 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 NORMAL | 134 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 BELOW | 3 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 ABOVE | 18 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 NORMAL | 16 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 BELOW | 59 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 NORMAL | 104 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 BELOW | 38 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 NORMAL | 23 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 BELOW | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 ABOVE | 50 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 7 NORMAL | 23 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 7 BELOW | 11 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 7 ABOVE | 7 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 NORMAL | 47 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 BELOW | 17 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 ABOVE | 35 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 NORMAL | 17 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 ABOVE | 31 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 NORMAL | 108 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 ABOVE | 61 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 7 NORMAL | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 7 BELOW | 7 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 NORMAL | 9 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 BELOW | 165 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 ABOVE | 2 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 NORMAL | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 ABOVE | 3 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 NORMAL | 10 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 ABOVE | 7 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 7 NORMAL | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 7 BELOW | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 NORMAL | 194 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 ABOVE | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 NORMAL | 10 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 BELOW | 19 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 NORMAL | 176 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 BELOW | 12 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 NORMAL | 6 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 ABOVE | 3 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 NORMAL | 5 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 BELOW | 16 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 NORMAL | 158 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 ABOVE | 3 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 BELOW | 26 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 BELOW | 26 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 NORMAL | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 NORMAL | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc.ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 ABOVE | 24 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 BELOW | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 NORMAL | 7 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 NORMAL | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 BELOW | 10 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 NORMAL | 57 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 BELOW | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 BELOW | 25 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 ABOVE | 31 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 ABOVE | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 NORMAL | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 NORMAL | 105 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 NORMAL | 45 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 7 NORMAL | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 BELOW | 8 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 ABOVE | 25 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 NORMAL | 13 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 7 NORMAL | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 BELOW | 17 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 7 BELOW | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 NORMAL | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 BELOW | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 NORMAL | 89 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 ABOVE | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 NORMAL | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 NORMAL | 12 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 NORMAL | 72 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 BELOW | 86 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 BELOW | 5 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 7 NORMAL | 9 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 7 BELOW | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 BELOW | 13 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 NORMAL | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 NORMAL | 56 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 BELOW | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 ABOVE | 9 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 BELOW | 10 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 NORMAL | 7 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 NORMAL | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 BELOW | 26 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 NORMAL | 52 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 ABOVE | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 BELOW | 20 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 7 NORMAL | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 NORMAL | 11 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 NORMAL | 68 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 BELOW | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 7 BELOW | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 ABOVE | 27 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 7 NORMAL | 8 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 7 BELOW | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 ABOVE | 16 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 7 ABOVE | 5 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 NORMAL | 96 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 NORMAL | 19 Participants |
Secondary
Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time frame: At Month 12
Population: The analysis was performed on the Total Vaccinated cohort on Senegalese subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 BELOW | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc.ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 NORMAL | 17 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 BELOW | 21 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 NORMAL | 139 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 BELOW | 24 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 ABOVE | 2 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 NORMAL | 210 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 12 NORMAL | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 NORMAL | 13 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 BELOW | 43 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 NORMAL | 130 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 BELOW | 23 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 NORMAL | 14 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 NORMAL | 8 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 ABOVE | 28 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 12 NORMAL | 13 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 12 BELOW | 6 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 NORMAL | 126 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 ABOVE | 17 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 NORMAL | 15 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 BELOW | 56 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 NORMAL | 108 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 BELOW | 32 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 NORMAL | 24 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 BELOW | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 ABOVE | 47 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 12 BELOW | 15 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 12 ABOVE | 14 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 NORMAL | 48 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 BELOW | 27 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 ABOVE | 23 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 NORMAL | 13 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 ABOVE | 32 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 NORMAL | 102 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 ABOVE | 64 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 12 NORMAL | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 12 BELOW | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 NORMAL | 11 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 BELOW | 160 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 ABOVE | 2 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 NORMAL | 7 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 BELOW | 22 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 NORMAL | 13 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 ABOVE | 4 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 12 NORMAL | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 12 BELOW | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 NORMAL | 188 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 BELOW | 3 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 ABOVE | 1 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 NORMAL | 8 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 BELOW | 19 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 NORMAL | 169 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 BELOW | 15 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 NORMAL | 6 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 ABOVE | 2 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 NORMAL | 10 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 BELOW | 9 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 NORMAL | 156 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 BELOW | 22 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 ABOVE | 6 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 BELOW | 6 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 12 NORMAL | 9 Participants |
| Cervarix Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 NORMAL | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 ABOVE | 14 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc.ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 NORMAL | 93 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 NORMAL | 10 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 NORMAL | 9 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 ABOVE | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 BELOW | 8 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 NORMAL | 61 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 ABOVE | 24 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 NORMAL | 5 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 ABOVE | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 NORMAL | 38 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 NORMAL | 102 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 ABOVE | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 12 NORMAL | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 ABOVE | 30 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 12 BELOW | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 NORMAL | 5 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. ABOVE, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 12 NORMAL | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 NORMAL | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 BELOW | 7 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 12 BELOW | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 BELOW | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 NORMAL | 64 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. ABOVE, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 BELOW | 8 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 BELOW | 17 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 NORMAL | 5 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 NORMAL | 11 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 BELOW | 83 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 ABOVE | 17 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 12 NORMAL | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 NORMAL | 80 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 12 BELOW | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 NORMAL | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. BELOW, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 BELOW | 23 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 NORMAL | 52 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 BELOW | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 BELOW | 9 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 ABOVE | 10 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 BELOW | 11 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 NORMAL | 10 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 BELOW | 23 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 NORMAL | 4 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 NORMAL | 45 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 NORMAL | 64 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 BELOW | 24 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 NORMAL | 7 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 NORMAL | 16 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 BELOW | 3 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 12 NORMAL | 1 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 ABOVE | 22 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 12 NORMAL | 8 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 12 BELOW | 5 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 12 BELOW | 2 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. BELOW, Month 12 ABOVE | 6 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 BELOW | 16 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 NORMAL | 24 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA. pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Senegalese Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 BELOW | 4 Participants |
Secondary
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies
A seroconverted subject was a subject with antibody titers below 8 or 7 Enzyme-linked Immunosorbent Assay Units per milliliter (EL.U/mL) for anti-HPV-16 and 18, respectively, before vaccination and antibody titers ≥ 8 or 7 EL.U/mL for anti-HPV-16 and 18, respectively, after vaccination. The groups were stratified by age for the analysis. The age strata were 10-14 years and 15-25 years.
Time frame: At Month 2 and Month 12
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 12 | 125 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 12 | 184 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 12 | 205 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 2 | 190 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 2 | 130 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 2 | 128 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 2 | 212 Participants |
| Cervarix Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 12 | 128 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 2 | 4 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 2 | 3 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-16 Month 12 | 7 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 2 | 1 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-18 Month 12 | 0 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 15-25 years anti-HPV-18 Month 12 | 6 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 12 | 2 Participants |
| Placebo Group | Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies | 10-14 years anti-HPV-16 Month 2 | 1 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain and swelling at the injection site. Any = occurrence of any solicited local symptom regardless of their intensity grade. Grade 3 swelling = swelling spreading beyond 50 millimeters (mm) of injection site. Grade 3 pain = pain that prevented normal activity.
Time frame: Within 7 days (Day 0-6) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 265 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 26 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 375 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 309 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 45 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 74 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 15 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 200 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 116 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 7 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 95 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 15 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 66 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 10 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across doses | 166 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across doses | 27 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were arthralgia (only joints that are distal from the injection site), fatigue, fever (defined as axillary temperature ≥ 37.5 degrees Celsius), gastrointestinal symptoms, headache, myalgia, rash and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: Within 7 days (Day 0-6) after each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 72 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 81 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 62 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 34 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 20 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 43 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 51 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 17 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 71 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 82 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 35 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 3 | 28 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 19 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 34 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 3 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 19 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 3 | 26 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 66 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 3 | 26 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 77 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 34 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 96 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 1 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 111 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 39 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 40 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 147 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 50 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 57 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 118 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 31 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 189 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 21 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 2 | 44 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 101 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 1 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 90 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 27 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 2 | 43 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Across doses | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Across doses | 68 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 3 | 28 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Across doses | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 89 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 3 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 47 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 34 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Across doses | 71 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 3 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 1 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 1 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 1 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 43 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 21 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 1 | 56 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 1 | 25 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 1 | 16 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 1 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 1 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 1 | 7 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 1 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 2 | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 2 | 2 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 2 | 25 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 2 | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 33 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 8 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 26 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 6 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 2 | 49 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 2 | 18 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Dose 2 | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 2 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 2 | 15 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Dose 3 | 10 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 3 | 13 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Dose 3 | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 33 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Dose 3 | 19 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Dose 3 | 5 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Dose 3 | 33 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Dose 3 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Dose 3 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 3 | 11 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Dose 3 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia, Across doses | 32 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia, Across doses | 4 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Across doses | 42 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue, Across doses | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across doses | 70 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across doses | 27 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal, Across doses | 56 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal, Across doses | 17 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache, Across doses | 109 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache, Across doses | 46 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia, Across doses | 36 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia, Across doses | 9 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash, Across doses | 30 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Across doses | 27 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria, Across doses | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue, Dose 1 | 12 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 0 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria, Dose 2 | 14 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria, Dose 2 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = any unsolicited AE regardless of intensity and relationship to vaccination. Grade 3 = an unsolicited AE that prevented normal everyday activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.
Time frame: Within 30 days (Day 0-29) after any vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 235 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 3 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any AE(s) | 142 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 AE(s) | 1 Participants |
| Placebo Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related AE(s) | 4 Participants |
Secondary
Number of Subjects With NOCDs and Other MSCs
New onset of chronic diseases (NOCDs) assessed included autoimmune disorders, asthma, type I diabetes, allergies. Medically significant conditions (MSCs) assessed included AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that were not related to common diseases. Common diseases included upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervico-vaginal yeast infections, menstrual cycle abnormalities and injury.
Time frame: From Day 0 up to Month 7 and from Month 7 up to Month 12
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With NOCDs and Other MSCs | NOCD(s) up to Month 7 | 10 Participants |
| Cervarix Group | Number of Subjects With NOCDs and Other MSCs | NOCD(s) Month 7-12 | 1 Participants |
| Cervarix Group | Number of Subjects With NOCDs and Other MSCs | MSC(s) up to Month 7 | 289 Participants |
| Cervarix Group | Number of Subjects With NOCDs and Other MSCs | MSC(s) Month 7-12 | 121 Participants |
| Placebo Group | Number of Subjects With NOCDs and Other MSCs | MSC(s) Month 7-12 | 68 Participants |
| Placebo Group | Number of Subjects With NOCDs and Other MSCs | NOCD(s) up to Month 7 | 8 Participants |
| Placebo Group | Number of Subjects With NOCDs and Other MSCs | MSC(s) up to Month 7 | 161 Participants |
| Placebo Group | Number of Subjects With NOCDs and Other MSCs | NOCD(s) Month 7-12 | 3 Participants |
Secondary
Number of Subjects With Pregnancies and Their Outcomes
Pregnancy outcomes were ectopic pregnancy, elective termination no apparent congenital anomaly, live infant no apparent congenital anomaly, premature live infant no apparent congenital anomaly, lost to follow-up and spontaneous abortion no apparent congenital anomaly.
Time frame: From Day 0 up to Month 12
Population: The analysis was performed on the Total Vaccinated cohort, which included vaccinated subjects with at least one vaccine administration documented and who reported pregnancies (and their outcomes).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes | Live infant | 5 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes | Lost to follow-up | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes | Spontaneous abortion | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes | Elective termination | 3 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes | Ectopic pregnancy | 1 Participants |
| Cervarix Group | Number of Subjects With Pregnancies and Their Outcomes | Premature live infant | 3 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Their Outcomes | Lost to follow-up | 0 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Their Outcomes | Elective termination | 3 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Their Outcomes | Live infant | 5 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Their Outcomes | Premature live infant | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Their Outcomes | Spontaneous abortion | 1 Participants |
| Placebo Group | Number of Subjects With Pregnancies and Their Outcomes | Ectopic pregnancy | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed included 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.
Time frame: From Day 0 up to Month 7 and from Month 7 up to Month 12
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | up to Month 7 | 12 Participants |
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) | up to Month 12 | 17 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | up to Month 7 | 10 Participants |
| Placebo Group | Number of Subjects With Serious Adverse Events (SAEs) | up to Month 12 | 14 Participants |
Secondary
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time frame: At Month 7
Population: The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 ABOVE | 4 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 NORMAL | 7 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 ABOVE | 3 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 7 NORMAL | 4 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 7 BELOW | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 NORMAL | 180 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 BELOW | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 ABOVE | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 7 NORMAL | 6 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 7 ABOVE | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 NORMAL | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 BELOW | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 NORMAL | 177 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 BELOW | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 ABOVE | 4 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 NORMAL | 13 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 NORMAL | 177 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 BELOW | 4 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 NORMAL | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 NORMAL | 7 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 BELOW | 6 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 NORMAL | 144 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 BELOW | 39 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 7 NORMAL | 19 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 7 ABOVE | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 NORMAL | 163 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 ABOVE | 15 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 NORMAL | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 BELOW | 41 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 NORMAL | 40 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 NORMAL | 14 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 ABOVE | 61 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 MISSING | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 ABOVE | 31 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. ABOVE, Month 7 NORMAL | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 NORMAL | 20 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 BELOW | 40 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 NORMAL | 118 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 BELOW | 20 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 ABOVE | 8 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 NORMAL | 166 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 BELOW | 3 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 ABOVE | 10 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 NORMAL | 6 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 ABOVE | 6 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 NORMAL | 180 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 ABOVE | 7 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 NORMAL | 13 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 BELOW | 22 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 MISSING | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 NORMAL | 145 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 BELOW | 17 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 BELOW | 116 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 NORMAL | 92 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 NORMAL | 12 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 NORMAL | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 BELOW | 12 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 NORMAL | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 7 ABOVE | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 7 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 NORMAL | 14 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 BELOW | 71 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 NORMAL | 9 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 NORMAL | 92 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 NORMAL | 81 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 NORMAL | 4 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 7 NORMAL | 4 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 7 ABOVE | 3 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 ABOVE | 35 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 BELOW | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 BELOW | 7 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 7 MISSING | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 NORMAL | 90 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 NORMAL | 52 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 7 ABOVE | 10 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 NORMAL | 6 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 7 ABOVE | 4 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 BELOW | 13 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 7 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 NORMAL | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 7 ABOVE | 8 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 NORMAL | 6 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. ABOVE, Month 7 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 NORMAL | 86 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 BELOW | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 7 ABOVE | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 NORMAL | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 7 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 BELOW | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 NORMAL | 6 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 NORMAL | 3 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 7 MISSING | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 BELOW | 8 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 BELOW | 29 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 NORMAL | 85 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 NORMAL | 65 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 BELOW | 20 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 NORMAL | 51 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 7 NORMAL | 12 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 BELOW | 13 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 7 NORMAL | 70 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 NORMAL | 81 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 7 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 7 NORMAL | 7 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 7 ABOVE | 6 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 7 ABOVE | 7 Participants |
Secondary
Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed
Biochemical and haematological parameters assessed were: Alanine amino-transferase (ALT), basophils (BAS), creatinine (CREA), eosinophils (EOS), hematocrit (HC), lymphocytes (LYM), monocytes (MON), neutrophils (NEU), platelets (PLA), red blood cells (RBC), white blood cells (WBC). Number of subjects were separated with respect to their results at pre-vaccination, i.e. whether their results were in, above or below the normal range. N for each category at pre-vaccination noted in category title. For each parameter and for each range it was assessed whether the values of the subjects were in, above or below the normal range.
Time frame: At Month 12
Population: The analysis was performed on the Total Vaccinated cohort on Tanzanian subjects with available results.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 NORMAL | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 NORMAL | 12 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 BELOW | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 NORMAL | 166 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 BELOW | 24 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 12 NORMAL | 21 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 12 ABOVE | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 NORMAL | 174 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 ABOVE | 9 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 NORMAL | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 BELOW | 40 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 NORMAL | 48 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 BELOW | 116 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 NORMAL | 22 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 ABOVE | 57 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 NORMAL | 93 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 ABOVE | 34 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 NORMAL | 29 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 BELOW | 34 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 NORMAL | 107 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 BELOW | 36 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 NORMAL | 9 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 ABOVE | 9 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 NORMAL | 168 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 ABOVE | 20 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 NORMAL | 8 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 ABOVE | 4 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 NORMAL | 184 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 ABOVE | 10 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 NORMAL | 18 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 BELOW | 18 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 NORMAL | 138 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 BELOW | 32 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 NORMAL | 8 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 ABOVE | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 12 NORMAL | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 NORMAL | 185 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 BELOW | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 ABOVE | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 12 NORMAL | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 12 ABOVE | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 NORMAL | 2 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 BELOW | 1 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 NORMAL | 182 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 BELOW | 6 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 ABOVE | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 NORMAL | 12 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 ABOVE | 5 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 NORMAL | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 BELOW | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 NORMAL | 165 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 BELOW | 14 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 ABOVE | 10 Participants |
| Cervarix Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 ABOVE | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 NORMAL | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 BELOW | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 BELOW | 5 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 NORMAL | 8 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 BELOW | 3 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 12 NORMAL | 3 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 NORMAL | 88 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 NORMAL | 73 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 BELOW | 13 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | ALT, pre-vacc. NORMAL, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 12 NORMAL | 12 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. NORMAL, Month 12 ABOVE | 7 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 NORMAL | 85 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 NORMAL | 6 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 NORMAL | 81 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. ABOVE, Month 12 ABOVE | 4 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 BELOW | 11 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | BAS, pre-vacc. NORMAL, Month 12 ABOVE | 8 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 BELOW | 14 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 NORMAL | 72 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 NORMAL | 19 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | MON, pre-vacc. ABOVE, Month 12 NORMAL | 6 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 BELOW | 69 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 BELOW | 13 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | CREA, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 NORMAL | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 NORMAL | 10 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | NEU, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. ABOVE, Month 12 ABOVE | 33 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 NORMAL | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 NORMAL | 48 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. BELOW, Month 12 BELOW | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | EOS, pre-vacc. NORMAL, Month 12 ABOVE | 11 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 NORMAL | 91 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 NORMAL | 10 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. ABOVE, Month 12 ABOVE | 1 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 BELOW | 28 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 12 NORMAL | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 NORMAL | 48 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 BELOW | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 BELOW | 16 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | HC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. NORMAL, Month 12 ABOVE | 4 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 NORMAL | 3 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 BELOW | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | RBC, pre-vacc. NORMAL, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. ABOVE, Month 12 ABOVE | 5 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 NORMAL | 96 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 NORMAL | 81 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. BELOW, Month 12 ABOVE | 0 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 BELOW | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | PLA, pre-vacc. NORMAL, Month 12 BELOW | 2 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | LYM, pre-vacc. NORMAL, Month 12 ABOVE | 11 Participants |
| Placebo Group | Number of Tanzanian Subjects With Clinically Relevant Abnormalities in Parameters Assessed | WBC, pre-vacc. ABOVE, Month 12 NORMAL | 5 Participants |