Infections, Papillomavirus
Conditions
Keywords
Immune response, Human papillomavirus, HPV vaccine, Safety
Brief summary
The current study evaluates the immunogenicity and safety in 4-6 years old female subjects (experimental group) receiving Cervarix according to a 2-dose schedule (Month 0, 6), as compared to 4-6 years old female subjects (control group) receiving sequentially Priorix (Month 0) and Infanrix (Month 6) vaccines.
Interventions
BIOLOGICALCervarix
2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.
BIOLOGICALPriorix
1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.
BIOLOGICALInfanrix
1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A female between, and including, 4 and 6 years of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to enrolment in the study. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Subjects who received four doses of DTP vaccine (i.e., three doses in the first year of life and a fourth dose in the second year of life) according to the schedule applicable in the participating countries. * Subjects who received a first dose of MMR vaccine according to the schedule applicable in the participating countries.
Exclusion criteria
* Child in care. * Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol. * Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine(s). Administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza and/or poliomyelitis vaccines up to 8 days before the first dose of study vaccine(s) is allowed. Enrolment will be deferred until the subject is outside of specified window. * 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(s), or planned use during the study period. * History of any reactions or hypersensitivity likely to be exacerbated by any component of the study vaccines, including latex and/or obvious allergic reactions to neomycin (a history of contact dermatitis to neomycin is not a contraindication), egg protein, etc. (e.g. hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock subsequent to egg ingestion). * Cancer or autoimmune disease under treatment. * 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). * Previous administration of MPL or AS04 adjuvant. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine(s) or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * Family history of congenital or hereditary immunodeficiency. * Documented human immunodeficiency virus (HIV)-positive subject. * Major congenital defects or serious chronic illness. * History of seizures or serious neurological disorder, which, according to the judgment of the investigator, precludes administration of any of the study vaccines. * Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, which in the opinion of the investigator precludes administration of the study vaccine(s). * Acute disease and/or fever at the time of enrolment. * Fever is defined as temperature ≥ 37.5°C on oral, axillary or tympanic setting, or ≥ 38.0°C on rectal setting. * Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. Enrolment can be deferred until condition is resolved. * Previous administration of the fifth dose of DTP vaccine and/or the second dose of MMR vaccine or planned administration of DTP vaccine and/or MMR vaccine outside the study (during the study period from Day 0 to Month 12). * History of tetanus, diphtheria, pertussis, measles, mumps and/or rubella. * Known exposure to diphtheria or household exposure to pertussis within 30 days prior to vaccination with DTPa. * Known exposure to measles, mumps and/or rubella 30 days prior to vaccination with the MMR study vaccine. * Confirmed or suspected tuberculosis. * Severe allergic reactions (e.g. anaphylaxis or severe Arthus-type hypersensitivity reactions) following the administration of previous dose(s) of DTP or MMR vaccines. * Hyperpyrexia (≥ 40.5°C) within 48 hours of administration of previous doses of DTP or MMR vaccines. * Persistent, inconsolable crying lasting more than 3 hours, occurring within 48 hours of administration of previous doses of DTP vaccine. * Collapse or shocking-like state (hypotonic-hyporesponsive episode) within 48 hours of administration of previous doses of DTP vaccine. * Idiopathic thrombocytopenic purpura or bleeding disorders. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose(s). (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses | Assessed solicited general symptoms were arthralgia (only in joints which were distal from the injection site), drowsiness, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, irritability/fussiness, loss of appetite, myalgia, rash (not urticaria, not measels/rubella-like rash), urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. 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) Reported During the 43-day Period Following the Vaccination at Day 0 | During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 | An unsolicited AE is 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. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 | An unsolicited AE is 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. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | At Day 42 (i.e. 42 days after the vaccination at Day 0) | The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes \[white blood cells\] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Day 42 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALAT Below (baseline) - Within (Day 42) = ALAT with below normal value at baseline and within normal values at Day 42\]. |
| Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | At Month 7 (i.e. 30 days after the vaccination at Month 6) | The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes \[white blood cells\] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Month 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALAT Below (baseline) - Within (Month 7) = ALAT with below normal value at baseline and within normal values at Month 7\]. |
| Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7 | From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6) | SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7 | From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6) | The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7 | From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6) | pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. |
| Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7 | From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6) | MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury. |
| Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7 | At Month 7 (i.e. 30 days after the vaccination at Month 6) | Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and the cut-offs were 19 ELISA Units per milliliter (EU/mL) for HPV-16 and 18 EU/mL for HPV-18. |
| Anti-HPV-16/18 Antibody Concentrations at Month 7 | At Month 7 (i.e. 30 days after the vaccination at Month 6) | Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE | Throughout the study period (i.e. from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group) | SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period | Throughout the study period (i.e from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group) | The number of subjects with AEs and SAEs leading to premature discontinuation of study was assessed. |
| Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 | Concomitant medication taken at least once during the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics. |
| Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group) | Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by ELISA and the cut-offs were 19 EU/mL for HPV-16 and 18 EU/mL for HPV-18. Note: Month 7 data are also reported in the Primary outcome measure. |
| Percentage of Subjects Completing the Vaccination Schedule in Both Groups | From Day 0 up to Month 6 (i.e. from first vaccination at Day 0 up to the second vaccination at Month 6) | The percentage of subjects who received the specified total number of doses (dose 1, dose 2, any dose) is reported. |
| Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 | Measles/Rubella-like rash: presence of macules, discoloured small patches or spots of the skin, neither elevated nor depressed below the skin's surface and/or papules, raised bumps on the skin usually below (\<) 1 cm in diameter. Parotid/salivary gland swelling: swelling/tenderness in the mandibular/submandibular region. Suspected signs of meningism including febrile convulsions: febrile convulsions or any other neurological signs or symptoms indicative of meningism. Any = occurrence of any solicited symptom regardless of their intensity grade or relationship to vaccination. Any fever = axillary temperature equal to or above (≥) 37.5°C. Grade 3 AE = AE which prevented normal, everyday activities. Grade 3 measles/rubella-like rash = more than 150 lesions. Grade 3 parotid gland swelling = swelling with accompanying general symptoms. Grade 3 fever = axillary temperature above (\>) 39.0°C. Related = any symptom assessed by the investigator as causally related to the vaccination. |
| Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 | Concomitant medication taken at least once during the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics. |
| Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group) | Antibody concentrations were assessed by ELISA and expressed as GMCs in EU/mL. Note: Month 7 data are also reported in the Primary outcome measure. |
| Number of Seropositive Subjects for Measles Antigen | At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0) | A seropositive subject was defined as a subject whose anti-measles antibody titer was equal to or above (≥) 150 milli-International Units per milliliter (mIU/mL), as assessed by ELISA. |
| Anti-measles Antibody Concentrations | At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0) | Anti-measles antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-measles antibody concentration ≥ 150 mIU/mL. |
| Number of Seropositive Subjects for Mumps Antigen | At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0) | A seropositive subject was defined as a subject whose anti-mumps antibody titer was equal to or above (≥) 231 U/mL, as assessed by ELISA. |
| Anti-mumps Antibody Concentrations | At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0) | Anti-mumps antibody concentrations were measured by ELISA, expressed as GMCs, in U/mL. The cut-off of the assay was an anti-mumps antibody concentration ≥ 231 U/mL. |
| Number of Seropositive Subjects for Rubella Antigen | At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0) | A seropositive subject was defined as a subject whose anti-rubella antibody titer was ≥ 4 IU/mL, as assessed by ELISA. |
| Anti-rubella Antibody Concentrations | At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0) | Anti-rubella antibody concentrations were measured by ELISA, expressed as GMCs, in IU/mL. The cut-off of the assay was an anti-rubella antibody concentration ≥ 4 IU/mL. |
| Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens | At Month 7 (i.e. 30 days after the vaccination at Month 6) | A seroprotected subject against diphtheria antigen was defined as a subject with an anti-diphtheria (anti-D) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA. A seroprotected subject against tetanus antigen was defined as a subject with an anti-tetanus (anti-T) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA. |
| Number of Subjects With pIMDs From Day 0 up to Month 12 | From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6) | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology. |
| Number of Subjects With MSCs From Day 0 up to Month 12 | From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6) | MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury. |
| Number of Subjects With SAEs From Day 0 up to Month 12 | From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6) | SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. |
Countries
Colombia, Mexico, Panama
Participant flow
Recruitment details
This study was conducted by multiple investigators at 7 centers in Colombia, Mexico and Panama.
Pre-assignment details
All 148 subjects enrolled in the study, received the study vaccination and were included in the Total Vaccinated cohort (TVC).
Participants by arm
| Arm | Count |
|---|---|
| Cervarix Group Healthy female subjects aged between, and including, 4 and 6 years, who received two doses of Cervarix vaccine at Day 0 and Month 6, administered intramuscularly in the deltoid muscle of the left upper arm. | 74 |
| Priorix + Infanrix Group Healthy female subjects aged between, and including, 4 and 6 years, who received one dose of Priorix vaccine at Day 0 and one dose of Infanrix vaccine at Month 6, administered intramuscularly in the deltoid muscle of the left upper arm. | 74 |
| Total | 148 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Migrated/moved from study area | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Cervarix Group | Priorix + Infanrix Group | Total |
|---|---|---|---|
| Age, Continuous | 4.3 Years STANDARD_DEVIATION 0.5 | 4.4 Years STANDARD_DEVIATION 0.5 | 4.3 Years STANDARD_DEVIATION 0.5 |
| Race/Ethnicity, Customized African Heritage / African American | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Mixed origin | 68 Participants | 68 Participants | 136 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 2 Participants | 4 Participants | 6 Participants |
| Sex: Female, Male Female | 74 Participants | 74 Participants | 148 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 / 74 | 0 / 74 |
| other Total, other adverse events | 70 / 74 | 65 / 74 |
| serious Total, serious adverse events | 1 / 74 | 2 / 74 |
Outcome results
Primary
Anti-HPV-16/18 Antibody Concentrations at Month 7
Antibody concentrations were assessed by ELISA and expressed as geometric mean concentrations (GMCs) in EU/mL.
Time frame: At Month 7 (i.e. 30 days after the vaccination at Month 6)
Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at the specified time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16/18 Antibody Concentrations at Month 7 | Anti-HPV-16 | 20080.0 EU/mL |
| Cervarix Group | Anti-HPV-16/18 Antibody Concentrations at Month 7 | Anti-HPV-18 | 10621.8 EU/mL |
| Priorix + Infanrix Group | Anti-HPV-16/18 Antibody Concentrations at Month 7 | Anti-HPV-16 | 10.4 EU/mL |
| Priorix + Infanrix Group | Anti-HPV-16/18 Antibody Concentrations at Month 7 | Anti-HPV-18 | 9.6 EU/mL |
Primary
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7
Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by Enzyme Linked Immunosorbent Assay (ELISA) and the cut-offs were 19 ELISA Units per milliliter (EU/mL) for HPV-16 and 18 EU/mL for HPV-18.
Time frame: At Month 7 (i.e. 30 days after the vaccination at Month 6)
Population: The analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7 | Anti-HPV-16 | 64 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7 | Anti-HPV-18 | 62 Participants |
| Priorix + Infanrix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7 | Anti-HPV-16 | 1 Participants |
| Priorix + Infanrix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7 | Anti-HPV-18 | 1 Participants |
Primary
Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7
The number of subjects with AEs and SAEs leading to premature discontinuation of the study was assessed.
Time frame: From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With AEs and SAEs Leading to Withdrawal From Day 0 up to Month 7 | 0 Participants |
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study, who had their symptom sheet filled in and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 6 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 10 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 16 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 3 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 | Any Pain Across doses | 54 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 43 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across doses | 18 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 2 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 45 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across doses | 19 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across doses | 4 Participants |
| Cervarix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Across doses | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Across doses | 18 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 1 | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 2 | 36 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Dose 2 | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Dose 2 | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Dose 2 | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling Dose 2 | 15 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling Dose 2 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Across doses | 40 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain Across doses | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness Across doses | 18 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness Across doses | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain Dose 1 | 15 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were arthralgia (only in joints which were distal from the injection site), drowsiness, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, irritability/fussiness, loss of appetite, myalgia, rash (not urticaria, not measels/rubella-like rash), urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability/fussiness = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day follow-up period (i.e. from the day of vaccination up to 6 subsequent days) after each vaccine dose and across doses
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study, who had their symptom sheet filled in and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 1 | 1 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 | Any Irritability/fussiness Across doses | 22 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 Across doses | 10 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia Dose 1 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue Dose 1 | 8 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 | Related Fatigue Dose 1 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Dose 1 | 7 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 | Related Gastrointestinal Dose 1 | 5 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache Dose 1 | 11 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 | Related Headache Dose 1 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 1 | 13 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 1 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 15 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 | Related Loss of appetite Dose 1 | 13 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia Dose 1 | 13 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 | Related Myalgia Dose 1 | 13 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash Dose 1 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash Dose 1 | 2 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria Dose 1 | 5 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 | Related Urticaria Dose 1 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia Dose 2 | 10 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 | Grade 3 Fatigue Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 7 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 | Related Fever Dose 2 | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Dose 2 | 4 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 | Related Gastrointestinal Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache Dose 2 | 12 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 | Related Headache Dose 2 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 2 | 18 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 2 | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 2 | 18 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia Dose 2 | 13 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 | Related Myalgia Dose 2 | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash Dose 2 | 3 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 | Related Rash Dose 2 | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria Dose 2 | 5 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 | Related Urticaria Dose 2 | 4 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia Across doses | 13 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 | Related Arthralgia Across doses | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Across doses | 16 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Across doses | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Across doses | 15 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue Across doses | 15 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 Fatigue Across doses | 14 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever Across doses | 12 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever Across doses | 9 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Across doses | 11 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 Gastrointestinal Across doses | 8 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache Across doses | 18 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 | Related Headache Across doses | 16 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Across doses | 22 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Across doses | 21 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Across doses | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Across doses | 19 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia Across doses | 21 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 Myalgia Across doses | 21 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash Across doses | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash Across doses | 5 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 Across doses | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache Dose 2 | 13 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria Across doses | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue Across doses | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache Dose 2 | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Across doses | 13 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia Dose 1 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 2 | 17 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia Dose 1 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever Across doses | 17 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash Across doses | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 2 | 17 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite Dose 2 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Across doses | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 1 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 2 | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever Across doses | 13 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 1 | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 2 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Dose 1 | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia Dose 2 | 11 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal Dose 1 | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Across doses | 16 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache Dose 1 | 19 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache Dose 1 | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Across doses | 13 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache Dose 1 | 17 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia Dose 2 | 11 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash Dose 2 | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite Dose 1 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal Across doses | 15 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia Dose 1 | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash Dose 2 | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Myalgia Across doses | 14 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia Dose 1 | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria Dose 2 | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Rash Dose 1 | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Rash Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache Across doses | 25 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash Dose 1 | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria Dose 1 | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Rash Across doses | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Urticaria Dose 1 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria Dose 2 | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Urticaria Dose 1 | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache Across doses | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia Dose 2 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Arthralgia Across doses | 11 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Myalgia Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Arthralgia Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia Dose 2 | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache Across doses | 23 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Dose 2 | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Arthralgia Across doses | 11 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/fussiness Across doses | 19 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Dose 2 | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness Across doses | 15 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue Dose 2 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Urticaria Across doses | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue Dose 2 | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever Dose 2 | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/fussiness Across doses | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness Across doses | 15 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever Dose 2 | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Myalgia Across doses | 14 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal Dose 2 | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue Across doses | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal Dose 2 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/fussiness Across doses | 19 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal Dose 2 | 8 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0
An unsolicited AE is 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. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination.
Time frame: During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0 | Any AE(s) | 40 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0 | Grade 3 AE(s) | 3 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0 | Related AE(s) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0 | Any AE(s) | 40 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0 | Grade 3 AE(s) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Reported During the 43-day Period Following the Vaccination at Day 0 | Related AE(s) | 5 Participants |
Primary
Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6
An unsolicited AE is 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. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related AE = AE assessed by the investigator as causally related to the study vaccination.
Time frame: During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available. Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | Any AE(s) | 18 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | Grade 3 AE(s) | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | Related AE(s) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | Any AE(s) | 13 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | Grade 3 AE(s) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related Unsolicited AEs Reported During the 30-day Period Following the Vaccination at Month 6 | Related AE(s) | 1 Participants |
Primary
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes \[white blood cells\] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Day 42 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALAT Below (baseline) - Within (Day 42) = ALAT with below normal value at baseline and within normal values at Day 42\].
Time frame: At Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Within (baseline) - Within (Day 42) | 42 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Above (baseline) - Within (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Below (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Above (baseline) - Above (Day 42) | 17 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Within (baseline) - Above (Day 42) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Below (baseline) - Within (Day 42) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Within (baseline) - Below (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Within (baseline) - Below (Day 42) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Above (baseline) - Within (Day 42) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Within (baseline) - Within (Day 42) | 60 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Within (baseline) - Above (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Within (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Above (baseline) - Above (Day 42) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Within (baseline) - Above (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Below (baseline) - Below (Day 42) | 12 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Below (baseline) - Within (Day 42) | 13 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Above (baseline) - Within (Day 42) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Unknown (baseline) - Within (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Within (baseline) - Within (Day 42) | 37 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Unknown (baseline) - Below (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Within (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Above (baseline) - Within (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Above (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Unknown (baseline) - Within (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Unknown (baseline) - Within (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Unknown (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Below (baseline) - Below (Day 42) | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Below (baseline) - Within (Day 42) | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Below (baseline) - Below (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Within (baseline) - Within (Day 42) | 38 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Below (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Below (baseline) - Below (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Above (baseline) - Within (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Above (baseline) - Above (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Below (baseline) - Below (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Within (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Below (baseline) - Within (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Within (baseline) - Below (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Below (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Within (baseline) - Within (Day 42) | 64 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Within (baseline) - Below (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Within (baseline) - Below (Day 42) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Within (baseline) - Within (Day 42) | 57 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Above (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Within (baseline) - Above (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Above (baseline) - Above (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Below (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Within (baseline) - Below (Day 42) | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Within (baseline) - Within (Day 42) | 38 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Above (baseline) - Above (Day 42) | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Above (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Below (baseline) - Within (Day 42) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Below (baseline) - Below (Day 42) | 9 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Within (baseline) - Within (Day 42) | 41 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Above (baseline) - Above (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Within (baseline) - Above (Day 42) | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Above (baseline) - Above (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Within (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Within (baseline) - Within (Day 42) | 51 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Within (baseline) - Above (Day 42) | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Within (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Within (baseline) - Below (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Above (baseline) - Within (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Within (baseline) - Within (Day 42) | 71 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Above (baseline) - Above (Day 42) | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Within (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Unknown (baseline) - Within (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Within (baseline) - Above (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Above (baseline) - Within (Day 42) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Below (baseline) - Below (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Below (baseline) - Within (Day 42) | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Unknown (baseline) - Within (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Within (baseline) - Below (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Within (baseline) - Within (Day 42) | 50 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Within (baseline) - Above (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Unknown (baseline) - Within (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Above (baseline) - Within (Day 42) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Above (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Below (baseline) - Below (Day 42) | 22 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Below (baseline) - Within (Day 42) | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Above (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Within (baseline) - Below (Day 42) | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Below (baseline) - Below (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Within (baseline) - Within (Day 42) | 35 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Below (baseline) - Within (Day 42) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Within (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Below (baseline) - Below (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Below (baseline) - Within (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Within (baseline) - Below (Day 42) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Below (baseline) - Above (Day 42) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Within (baseline) - Within (Day 42) | 42 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Below (baseline) - Within (Day 42) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Within (baseline) - Above (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Above (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Above (baseline) - Below (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Below (baseline) - Below (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Below (baseline) - Below (Day 42) | 15 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Within (baseline) - Above (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Below (baseline) - Below (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Above (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Within (baseline) - Within (Day 42) | 54 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Within (baseline) - Above (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Above (baseline) - Above (Day 42) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Below (baseline) - Below (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Below (baseline) - Within (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Within (baseline) - Below (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Within (baseline) - Above (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Above (baseline) - Below (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Within (baseline) - Above (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Below (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Within (baseline) - Below (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Above (baseline) - Above (Day 42) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Below (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Within (baseline) - Within (Day 42) | 52 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Within (baseline) - Within (Day 42) | 57 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Below (baseline) - Below (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Below (baseline) - Within (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Within (baseline) - Below (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Within (baseline) - Within (Day 42) | 48 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Above (baseline) - Within (Day 42) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | MONO, Above (baseline) - Above (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Below (baseline) - Below (Day 42) | 14 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Unknown (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Below (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Below (baseline) - Within (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Within (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Within (baseline) - Within (Day 42) | 60 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Within (baseline) - Above (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Above (baseline) - Within (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | ALAT, Above (baseline) - Above (Day 42) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Within (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Within (baseline) - Within (Day 42) | 69 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Within (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Above (baseline) - Within (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BAS, Above (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Unknown (baseline) - Below (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Unknown (baseline) - Within (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Below (baseline) - Below (Day 42) | 17 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Below (baseline) - Within (Day 42) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Within (baseline) - Below (Day 42) | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Within (baseline) - Within (Day 42) | 33 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | CREA, Within (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Within (baseline) - Below (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Within (baseline) - Within (Day 42) | 38 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Within (baseline) - Above (Day 42) | 11 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Above (baseline) - Within (Day 42) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | EOS, Above (baseline) - Above (Day 42) | 12 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Below (baseline) - Within (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Within (baseline) - Below (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Within (baseline) - Within (Day 42) | 63 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Within (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Above (baseline) - Within (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | RBC, Above (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Below (baseline) - Within (Day 42) | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Below (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Within (baseline) - Below (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Within (baseline) - Within (Day 42) | 38 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Above (baseline) - Within (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HCT, Above (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Below (baseline) - Within (Day 42) | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Within (baseline) - Below (Day 42) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Within (baseline) - Within (Day 42) | 42 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Within (baseline) - Above (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | HGB, Above (baseline) - Within (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Below (baseline) - Below (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Below (baseline) - Within (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Below (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Within (baseline) - Below (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | WBC, Above (baseline) - Within (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Below (baseline) - Above (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Within (baseline) - Within (Day 42) | 34 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Above (baseline) - Within (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | LYM, Above (baseline) - Above (Day 42) | 14 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Below (baseline) - Within (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Within (baseline) - Within (Day 42) | 39 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Within (baseline) - Above (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | NEU, Above (baseline) - Within (Day 42) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Below (baseline) - Within (Day 42) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Within (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Within (baseline) - Above (Day 42) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Above (baseline) - Within (Day 42) | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | PLA, Above (baseline) - Above (Day 42) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Unknown (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Unknown (baseline) - Within (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Unknown (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Below (baseline) - Below (Day 42) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Below (baseline) - Within (Day 42) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Below (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Within (baseline) - Below (Day 42) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Within (baseline) - Above (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Above (baseline) - Below (Day 42) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Day 42 by Baseline Ranges | BUN, Above (baseline) - Within (Day 42) | 6 Participants |
Primary
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges
The parameters assessed were both biochemical (alanine aminotransferase = ALAT, creatinine = CREA, blood urea nitrogen = BUN) and haematological (basophils = BAS, eosinophils = EOS, red blood cells = RBC, hematocrit = HCT, hemoglobin = HGB, leukocytes \[white blood cells\] = WBC, lymphocytes = LYM, monocytes = MONO, neutrophils = NEU and platelets = PLA). Abnormal laboratory values at Month 7 were Below, Within and Above normal ranges, as compared to the baseline status of the same parameter, at Day 0 (Unknown, Below, Within and Above normal ranges) \[e.g. ALAT Below (baseline) - Within (Month 7) = ALAT with below normal value at baseline and within normal values at Month 7\].
Time frame: At Month 7 (i.e. 30 days after the vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Within (baseline) - Within (Month 7) | 63 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Within (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Within (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Unknown (baseline) - Within (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Unknown (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Below (baseline) - Below (Month 7) | 15 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Below (baseline) - Within (Month 7) | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Above (baseline) - Within (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Within (baseline) - Below (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Above (baseline) - Within (Month 7) | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Within (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Above (baseline) - Above (Month 7) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Below (baseline) - Within (Month 7) | 7 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Above (baseline) - Within (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Above (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Below (baseline) - Within (Month 7) | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Below (baseline) - Below (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Unknown (baseline) - Within (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Within (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Below (baseline) - Within (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Within (baseline) - Within (Month 7) | 40 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Below (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Within (baseline) - Above (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Within (baseline) - Below (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Below (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Above (baseline) - Above (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Within (baseline) - Above (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Above (baseline) - Within (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Above (baseline) - Above (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Within (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Below (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Within (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Below (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Within (baseline) - Within (Month 7) | 64 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Above (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Within (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Within (baseline) - Above (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Within (baseline) - Within (Month 7) | 59 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Within (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Below (baseline) - Within (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Above (baseline) - Within (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Within (baseline) - Below (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Within (baseline) - Within (Month 7) | 49 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Below (baseline) - Below (Month 7) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Below (baseline) - Within (Month 7) | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Below (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Within (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Within (baseline) - Below (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Within (baseline) - Within (Month 7) | 43 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Within (baseline) - Within (Month 7) | 72 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Within (baseline) - Above (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Below (baseline) - Below (Month 7) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Above (baseline) - Above (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Within (baseline) - Within (Month 7) | 34 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Unknown (baseline) - Within (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Within (baseline) - Below (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Unknown (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Within (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Within (baseline) - Within (Month 7) | 37 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Within (baseline) - Within (Month 7) | 56 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Within (baseline) - Above (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Below (baseline) - Below (Month 7) | 23 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Within (baseline) - Within (Month 7) | 41 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Below (baseline) - Within (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Above (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Unknown (baseline) - Within (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Above (baseline) - Within (Month 7) | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Within (baseline) - Below (Month 7) | 8 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Below (baseline) - Below (Month 7) | 5 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Above (baseline) - Above (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Unknown (baseline) - Within (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Within (baseline) - Below (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Within (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Within (baseline) - Within (Month 7) | 47 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Within (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Unknown (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Above (baseline) - Within (Month 7) | 6 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Above (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Below (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Below (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Unknown (baseline) - Within (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Within (baseline) - Within (Month 7) | 42 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Below (baseline) - Below (Month 7) | 2 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Within (baseline) - Above (Month 7) | 9 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Unknown (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Below (baseline) - Below (Month 7) | 10 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Above (baseline) - Within (Month 7) | 3 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Within (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Above (baseline) - Above (Month 7) | 18 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Below (baseline) - Below (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Above (baseline) - Below (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Below (baseline) - Within (Month 7) | 4 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Above (baseline) - Within (Month 7) | 11 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Below (baseline) - Above (Month 7) | 0 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Above (baseline) - Above (Month 7) | 1 Participants |
| Cervarix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Above (baseline) - Within (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Above (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Within (baseline) - Within (Month 7) | 67 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Unknown (baseline) - Within (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Within (baseline) - Within (Month 7) | 61 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Above (baseline) - Within (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Above (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Below (baseline) - Below (Month 7) | 15 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Above (baseline) - Within (Month 7) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Above (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Below (baseline) - Within (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Within (baseline) - Below (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Within (baseline) - Within (Month 7) | 48 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Within (baseline) - Above (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Below (baseline) - Below (Month 7) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Within (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Above (baseline) - Above (Month 7) | 11 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Below (baseline) - Within (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Within (baseline) - Below (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Within (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Below (baseline) - Below (Month 7) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Within (baseline) - Above (Month 7) | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Within (baseline) - Within (Month 7) | 51 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Unknown (baseline) - Within (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Below (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Below (baseline) - Within (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Within (baseline) - Below (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Within (baseline) - Within (Month 7) | 60 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Within (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Above (baseline) - Within (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | ALAT, Above (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Within (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Within (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Above (baseline) - Within (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BAS, Above (baseline) - Above (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Unknown (baseline) - Below (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Below (baseline) - Below (Month 7) | 21 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Below (baseline) - Within (Month 7) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Within (baseline) - Below (Month 7) | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Within (baseline) - Within (Month 7) | 36 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | CREA, Within (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Within (baseline) - Below (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Within (baseline) - Within (Month 7) | 38 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Within (baseline) - Above (Month 7) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Above (baseline) - Within (Month 7) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | EOS, Above (baseline) - Above (Month 7) | 13 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Below (baseline) - Below (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Below (baseline) - Within (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Within (baseline) - Below (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Within (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | RBC, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Below (baseline) - Within (Month 7) | 9 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Within (baseline) - Below (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Within (baseline) - Within (Month 7) | 40 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Within (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Above (baseline) - Within (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HCT, Above (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Below (baseline) - Below (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Below (baseline) - Within (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Below (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Within (baseline) - Below (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Within (baseline) - Within (Month 7) | 44 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Within (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | HGB, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Below (baseline) - Below (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Above (baseline) - Within (Month 7) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | WBC, Above (baseline) - Above (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Below (baseline) - Within (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Below (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Within (baseline) - Below (Month 7) | 5 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Within (baseline) - Within (Month 7) | 36 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Above (baseline) - Below (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | LYM, Above (baseline) - Within (Month 7) | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Below (baseline) - Below (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Below (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Within (baseline) - Within (Month 7) | 51 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Above (baseline) - Within (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | MONO, Above (baseline) - Above (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Below (baseline) - Within (Month 7) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Below (baseline) - Above (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Within (baseline) - Below (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Within (baseline) - Within (Month 7) | 35 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Above (baseline) - Below (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Above (baseline) - Within (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | NEU, Above (baseline) - Above (Month 7) | 3 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Below (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Below (baseline) - Within (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Within (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Within (baseline) - Within (Month 7) | 53 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Within (baseline) - Above (Month 7) | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Above (baseline) - Within (Month 7) | 8 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | PLA, Above (baseline) - Above (Month 7) | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Unknown (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Unknown (baseline) - Within (Month 7) | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Unknown (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Below (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Below (baseline) - Within (Month 7) | 4 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Within (baseline) - Below (Month 7) | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Within (baseline) - Above (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Above (baseline) - Below (Month 7) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters at Month 7 by Baseline Ranges | BUN, Above (baseline) - Within (Month 7) | 6 Participants |
Primary
Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7
MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time frame: From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7 | 37 Participants |
| Priorix + Infanrix Group | Number of Subjects With Medically Significant Conditions (MSCs) From Day 0 up to Month 7 | 28 Participants |
Primary
Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7
pIMDs were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
Time frame: From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) From Day 0 up to Month 7 | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 up to Month 7 (i.e. from first vaccination at Day 0 up to 30 days after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Serious Adverse Events (SAEs) From Day 0 up to Month 7 | 2 Participants |
Secondary
Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group)
Antibody concentrations were assessed by ELISA and expressed as GMCs in EU/mL. Note: Month 7 data are also reported in the Primary outcome measure.
Time frame: At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects for whom data concerning immunogenicity outcome measures were available at the specified time point. Priorix+Infanrix Group data were only tabulated for the time points up to Month 12, since the follow-up phase for this group ended at Month 12.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 36 | 536.4 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 12 | 1216.6 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 18 | 802.9 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 24 | 766.6 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 7 | 20080.0 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 12 | 3246.5 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 18 | 2800.5 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 24 | 1951.9 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 36 | 1680.6 EU/mL |
| Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 7 | 10621.8 EU/mL |
| Priorix + Infanrix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 7 | 10.4 EU/mL |
| Priorix + Infanrix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 12 | 9.0 EU/mL |
| Priorix + Infanrix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 12 | 9.7 EU/mL |
| Priorix + Infanrix Group | Anti-HPV-16 and Anti-HPV-18 Antibody Concentrations at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 7 | 9.6 EU/mL |
Secondary
Anti-measles Antibody Concentrations
Anti-measles antibody concentrations were measured by ELISA, expressed as GMCs, in mIU/mL. The cut-off of the assay was an anti-measles antibody concentration ≥ 150 mIU/mL.
Time frame: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-measles Antibody Concentrations | Anti-measles, Day 0 | 1029.8 mIU/mL |
| Cervarix Group | Anti-measles Antibody Concentrations | Anti-measles, Day 42 | 897.1 mIU/mL |
| Priorix + Infanrix Group | Anti-measles Antibody Concentrations | Anti-measles, Day 0 | 694.8 mIU/mL |
| Priorix + Infanrix Group | Anti-measles Antibody Concentrations | Anti-measles, Day 42 | 2512.3 mIU/mL |
Secondary
Anti-mumps Antibody Concentrations
Anti-mumps antibody concentrations were measured by ELISA, expressed as GMCs, in U/mL. The cut-off of the assay was an anti-mumps antibody concentration ≥ 231 U/mL.
Time frame: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-mumps Antibody Concentrations | Anti-mumps, Day 0 | 3613.7 U/mL |
| Cervarix Group | Anti-mumps Antibody Concentrations | Anti-mumps, Day 42 | 3594.1 U/mL |
| Priorix + Infanrix Group | Anti-mumps Antibody Concentrations | Anti-mumps, Day 0 | 2142.6 U/mL |
| Priorix + Infanrix Group | Anti-mumps Antibody Concentrations | Anti-mumps, Day 42 | 7001.1 U/mL |
Secondary
Anti-rubella Antibody Concentrations
Anti-rubella antibody concentrations were measured by ELISA, expressed as GMCs, in IU/mL. The cut-off of the assay was an anti-rubella antibody concentration ≥ 4 IU/mL.
Time frame: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cervarix Group | Anti-rubella Antibody Concentrations | Anti-rubella, Day 0 | 82.0 IU/mL |
| Cervarix Group | Anti-rubella Antibody Concentrations | Anti-rubella, Day 42 | 79.3 IU/mL |
| Priorix + Infanrix Group | Anti-rubella Antibody Concentrations | Anti-rubella, Day 42 | 124.2 IU/mL |
| Priorix + Infanrix Group | Anti-rubella Antibody Concentrations | Anti-rubella, Day 0 | 48.9 IU/mL |
Secondary
Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group)
Seroconversion was defined as a titer greater than or equal to the cut-off value in the serum of seronegative subjects, defined as subjects who had an antibody titer below the cut-off value before vaccination. Titers were measured by ELISA and the cut-offs were 19 EU/mL for HPV-16 and 18 EU/mL for HPV-18. Note: Month 7 data are also reported in the Primary outcome measure.
Time frame: At Month 7, Month 12 (for both groups) and at Month 18, Month 24 and Month 36 (only for Cervarix Group)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects for whom data concerning immunogenicity outcome measures were available at the specified time point. Priorix+Infanrix Group data were only tabulated for the time points up to Month 12, since the follow-up phase for this group ended at Month 12.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 36 | 65 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 36 | 67 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 7 | 62 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 7 | 64 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 12 | 65 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 24 | 67 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 12 | 63 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 18 | 64 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 24 | 65 Participants |
| Cervarix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 18 | 66 Participants |
| Priorix + Infanrix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 12 | 1 Participants |
| Priorix + Infanrix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-16, Month 7 | 1 Participants |
| Priorix + Infanrix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 12 | 0 Participants |
| Priorix + Infanrix Group | Number of Seroconverted Subjects for HPV-16 and HPV-18 Antigens at Month 7, Month 12 (for Both Groups) and at Month 18, Month 24 and Month 36 (Only for Cervarix Group) | Anti-HPV-18, Month 7 | 1 Participants |
Secondary
Number of Seropositive Subjects for Measles Antigen
A seropositive subject was defined as a subject whose anti-measles antibody titer was equal to or above (≥) 150 milli-International Units per milliliter (mIU/mL), as assessed by ELISA.
Time frame: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seropositive Subjects for Measles Antigen | Anti-measles, Day 0 | 65 Participants |
| Cervarix Group | Number of Seropositive Subjects for Measles Antigen | Anti-measles, Day 42 | 67 Participants |
| Priorix + Infanrix Group | Number of Seropositive Subjects for Measles Antigen | Anti-measles, Day 42 | 58 Participants |
| Priorix + Infanrix Group | Number of Seropositive Subjects for Measles Antigen | Anti-measles, Day 0 | 50 Participants |
Secondary
Number of Seropositive Subjects for Mumps Antigen
A seropositive subject was defined as a subject whose anti-mumps antibody titer was equal to or above (≥) 231 U/mL, as assessed by ELISA.
Time frame: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seropositive Subjects for Mumps Antigen | Anti-mumps, Day 0 | 64 Participants |
| Cervarix Group | Number of Seropositive Subjects for Mumps Antigen | Anti-mumps, Day 42 | 66 Participants |
| Priorix + Infanrix Group | Number of Seropositive Subjects for Mumps Antigen | Anti-mumps, Day 0 | 50 Participants |
| Priorix + Infanrix Group | Number of Seropositive Subjects for Mumps Antigen | Anti-mumps, Day 42 | 57 Participants |
Secondary
Number of Seropositive Subjects for Rubella Antigen
A seropositive subject was defined as a subject whose anti-rubella antibody titer was ≥ 4 IU/mL, as assessed by ELISA.
Time frame: At Day 0 and Day 42 (i.e. 42 days after the vaccination at Day 0)
Population: The analysis was performed on the ATP cohort for immunogenicity at Day 42, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Day 42.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seropositive Subjects for Rubella Antigen | Anti-rubella, Day 0 | 66 Participants |
| Cervarix Group | Number of Seropositive Subjects for Rubella Antigen | Anti-rubella, Day 42 | 68 Participants |
| Priorix + Infanrix Group | Number of Seropositive Subjects for Rubella Antigen | Anti-rubella, Day 0 | 53 Participants |
| Priorix + Infanrix Group | Number of Seropositive Subjects for Rubella Antigen | Anti-rubella, Day 42 | 58 Participants |
Secondary
Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens
A seroprotected subject against diphtheria antigen was defined as a subject with an anti-diphtheria (anti-D) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA. A seroprotected subject against tetanus antigen was defined as a subject with an anti-tetanus (anti-T) antibody concentration ≥ the cut-off of 0.1 IU/mL, as measured by ELISA.
Time frame: At Month 7 (i.e. 30 days after the vaccination at Month 6)
Population: The analysis was performed on the ATP cohort for immunogenicity at Month 7, which included all eligible subjects (i.e. meeting all eligibility criteria, complying with the procedures defined in the protocol) for whom data concerning immunogenicity outcome measures were available at Month 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens | Anti-D | 45 Participants |
| Cervarix Group | Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens | Anti-T | 60 Participants |
| Priorix + Infanrix Group | Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens | Anti-D | 47 Participants |
| Priorix + Infanrix Group | Number of Seroprotected Subjects Against Diphtheria and Tetanus Antigens | Anti-T | 47 Participants |
Secondary
Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6
Concomitant medication taken at least once during the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics.
Time frame: During the 30-day period (i.e. from the day of vaccination up to 29 subsequent days) following the vaccination at Month 6
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available. Out of the 74 subjects present in the initial Priorix + Infanrix Group, 3 did not receive the second vaccination and were hence excluded from this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Any medication | 19 Participants |
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Any antipyretic | 10 Participants |
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Prophylactic antipyretic | 0 Participants |
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Any antibiotic | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Any antibiotic | 6 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Any medication | 23 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Prophylactic antipyretic | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 30-day Period Following the Vaccination at Month 6 | Any antipyretic | 8 Participants |
Secondary
Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0
Concomitant medication taken at least once during the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0 included: any type of medicines, antipyretics, prophylactic antipyretics and antibiotics.
Time frame: During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Any antibiotic | 18 Participants |
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Any medication | 45 Participants |
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Any antipyretic | 29 Participants |
| Cervarix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Prophylactic antipyretic | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Prophylactic antipyretic | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Any antibiotic | 10 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Any antipyretic | 24 Participants |
| Priorix + Infanrix Group | Number of Subjects Reporting the Intake of Concomitant Medication During the 43-day Period Following the Vaccination at Day 0 | Any medication | 36 Participants |
Secondary
Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period
The number of subjects with AEs and SAEs leading to premature discontinuation of study was assessed.
Time frame: Throughout the study period (i.e from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With AEs/SAEs Leading to Withdrawal Throughout the Study Period | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion
Measles/Rubella-like rash: presence of macules, discoloured small patches or spots of the skin, neither elevated nor depressed below the skin's surface and/or papules, raised bumps on the skin usually below (\<) 1 cm in diameter. Parotid/salivary gland swelling: swelling/tenderness in the mandibular/submandibular region. Suspected signs of meningism including febrile convulsions: febrile convulsions or any other neurological signs or symptoms indicative of meningism. Any = occurrence of any solicited symptom regardless of their intensity grade or relationship to vaccination. Any fever = axillary temperature equal to or above (≥) 37.5°C. Grade 3 AE = AE which prevented normal, everyday activities. Grade 3 measles/rubella-like rash = more than 150 lesions. Grade 3 parotid gland swelling = swelling with accompanying general symptoms. Grade 3 fever = axillary temperature above (\>) 39.0°C. Related = any symptom assessed by the investigator as causally related to the vaccination.
Time frame: During the 43-day period (i.e. from the day of vaccination up to 42 subsequent days) following the vaccination at Day 0
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Fever | 7 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Measles/Rubella-like rash | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Signs of meningism | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Parotid gland swelling | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Parotid gland swelling | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Fever | 6 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Parotid gland swelling | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Fever | 30 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Signs of meningism | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Measles/Rubella-like rash | 1 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Signs of meningism | 0 Participants |
| Cervarix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Measles/Rubella-like rash | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Signs of meningism | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Parotid gland swelling | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Fever | 27 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Fever | 2 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Fever | 7 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Measles/Rubella-like rash | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Measles/Rubella-like rash | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Measles/Rubella-like rash | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Parotid gland swelling | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Related Parotid gland swelling | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Any Signs of meningism | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With Any, Grade 3 and Related to Vaccination Solicited Fever, Measles/Rubella-like Rash, Parotid Gland Swelling and Signs of Meningism Including Febrile Convulsion | Grade 3 Signs of meningism | 0 Participants |
Secondary
Number of Subjects With MSCs From Day 0 up to Month 12
MSCs were defined as AEs prompting emergency room or physician visits that were not related to common diseases or were not routine visits for physical examination or vaccination and as SAEs that were not related to common diseases. Common diseases included: upper respiratory tract infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
Time frame: From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With MSCs From Day 0 up to Month 12 | 38 Participants |
| Priorix + Infanrix Group | Number of Subjects With MSCs From Day 0 up to Month 12 | 29 Participants |
Secondary
Number of Subjects With pIMDs From Day 0 up to Month 12
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not have an autoimmune aetiology.
Time frame: From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With pIMDs From Day 0 up to Month 12 | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With pIMDs From Day 0 up to Month 12 | 0 Participants |
Secondary
Number of Subjects With SAEs From Day 0 up to Month 12
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 up to Month 12 (i.e. from first vaccination at Day 0 up to 6 months after the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cervarix Group | Number of Subjects With SAEs From Day 0 up to Month 12 | 1 Participants |
| Priorix + Infanrix Group | Number of Subjects With SAEs From Day 0 up to Month 12 | 2 Participants |
Secondary
Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: Throughout the study period (i.e. from Day 0 up to Month 12 for Priorix + Infanrix Group and from Day 0 up to Month 36 for Cervarix Group)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cervarix Group | Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE | Related SAE(s) | 0 Participants |
| Cervarix Group | Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE | Fatal SAE(s) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE | Related SAE(s) | 0 Participants |
| Priorix + Infanrix Group | Number of Subjects With SAEs Related to the Investigational Products or Any Fatal SAE | Fatal SAE(s) | 0 Participants |
Secondary
Percentage of Subjects Completing the Vaccination Schedule in Both Groups
The percentage of subjects who received the specified total number of doses (dose 1, dose 2, any dose) is reported.
Time frame: From Day 0 up to Month 6 (i.e. from first vaccination at Day 0 up to the second vaccination at Month 6)
Population: The analysis was based on the Total vaccinated cohort (TVC), which included all vaccinated subjects who received at least one dose of vaccine in this study and for whom data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cervarix Group | Percentage of Subjects Completing the Vaccination Schedule in Both Groups | Subjects receiving only 1 dose | 0 Percentage of subjects |
| Cervarix Group | Percentage of Subjects Completing the Vaccination Schedule in Both Groups | Subjects receiving 2 doses | 100 Percentage of subjects |
| Cervarix Group | Percentage of Subjects Completing the Vaccination Schedule in Both Groups | Subjects receiving at least 1 dose | 100 Percentage of subjects |
| Priorix + Infanrix Group | Percentage of Subjects Completing the Vaccination Schedule in Both Groups | Subjects receiving only 1 dose | 4.1 Percentage of subjects |
| Priorix + Infanrix Group | Percentage of Subjects Completing the Vaccination Schedule in Both Groups | Subjects receiving 2 doses | 95.9 Percentage of subjects |
| Priorix + Infanrix Group | Percentage of Subjects Completing the Vaccination Schedule in Both Groups | Subjects receiving at least 1 dose | 100 Percentage of subjects |