Infections, Meningococcal
Conditions
Keywords
pertussis, Meningococcal meningitis, Meningococcal infections, HPV, Neisseria meningitidis, Vaccines, conjugate, tetanus, diphtheria, Meningococcal vaccines, Immunogenicity
Brief summary
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the co-administration of MenACWY-TT with Cervarix and Boostrix as compared to MenACWY-TT administered alone and Cervarix co-administered with Boostrix.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
One dose administered intramuscularly (IM) in the deltoid of the right arm.
BIOLOGICALCervarix®
Three doses administered intramuscularly (IM) in the deltoid of the left arm.
BIOLOGICALBoostrix®
One dose administered intramuscularly (IM) in the deltoid of the left arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
9 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects and subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A female between, and including, 9 and 25 years of age at the time of the first vaccination. * Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than legal age, or written informed consent obtained from the subject if the subject has achieved legal age. The legal age will be determined according to local regulations in each participating country. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to vaccination, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will be ≥10 mg/day prednisone or equivalent. Inhaled and topical steroids are allowed. * Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after each study dose of vaccine(s), with the exception of licensed inactivated influenza vaccine. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational product or a non-investigational vaccine/product. * Previous vaccination with a meningococcal polysaccharide or conjugate vaccine within the last 10 years. * History of meningococcal disease since birth. * History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines. * History of encephalopathy within seven days of administration of a previous pertussis antigen-containing vaccine that is not attributable to another identifiable cause. * Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of tetanus-toxoid containing vaccine should not receive Boostrix unless at least 10 years have elapsed since the last dose of tetanus-toxoid containing vaccine. * Previous vaccination with a tetanus-toxoid containing vaccine within the previous five years. * Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine (diphtheria-tetanus-whole cell pertussis \[DTPw\] and/or diphtheria-tetanus-acellular pertussis \[DTaP\]), not due to another identifiable cause. * Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine. * Seizures with or without fever within three days of a previous dose of DTP vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and history directed physical examination. * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * History of any allergic disease/reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Progressive neurologic disorder, unstable neurologic conditions, uncontrolled epilepsy or progressive encephalopathy. * History of any neurologic disorders or seizures. A history of ADHD or depression or a history of a single, simple febrile seizure does not exclude a subject. * Major congenital defects or serious chronic illness. * Previous history of Guillain-Barré Syndrome. * Bleeding disorders, such as hemophilia or thrombocytopenia, or subjects on anti-coagulant therapy. * Acute disease and/or fever at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Previous vaccination against HPV, or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period. * Previous administration of MPL or AS04 adjuvant. * History of chronic alcohol consumption and/or drug abuse. * Pregnant or lactating female. * A subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * Subjects must be at least three months post-pregnancy and not breastfeeding to enter the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | At one month after vaccination with Nimenrix (Month 1) | The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine. |
| Anti-HPV-16 and Anti-HPV-18 Concentrations | At one month after vaccination with Cervarix (Month 7) | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). |
| Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL | At one month after Boostrix vaccination (Month 1) | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine. |
| Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | At one month after Boostrix vaccination (Month 1) | The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events SAE(s) | During the entire study period (from Month 0 to Month 8) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group] | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL). |
| Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8) | Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL. |
| Anti-HPV-16 and Anti-HPV-18 Concentrations | Prior to and one month after the third dose of Cervarix (Months 0 and 8) | The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group. |
| Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | At one month after Boostrix vaccination (Month 1) | Booster responses to the PT, FHA and PRN antigens were defined as: * For initially seronegative subjects (antibody concentrations: \< 2.046 IU/ml for anti-FHA, \< 2.187 IU/ml for anti-PRN, \< 2.693 IU/ml for anti-PT), antibody concentration ≥ 4\*cut\_off IU/ml at Month 1 post-vaccination; * For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration \< 4\*cut\_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration; * For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4\*cut\_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration. |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Prior to and one month after Boostrix vaccination (Month 0 and Month 1) | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | Prior to and one month after vaccination with Nimenrix (Months 0 and 1) | The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine. |
| Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Prior to and one month after Boostrix vaccination (Months 0 and 1) | The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL. |
| Number of Subjects Reporting Solicited Local Symptoms | During the 7-day (Days 0-6) post-vaccination period following each 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 = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for Dose 2 because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint. |
| Number of Subjects Reporting Solicited General Symptoms | During the 7-day (Days 0-6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for Dose 2 because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint. |
| Number of Subjects With Unsolicited Adverse Events AE(s) | During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any 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 assessed by the investigator as related to the vaccination. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | During the entire study period (from Month 0 to Month 8) | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. |
| Number of Subjects With New Onset Chronic Illnesses (NOCIs) | During the entire study period (from Month 0 to Month 8) | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Anti-D and Anti-T Antibody Concentrations | Prior to and one month after Boostrix vaccination (Months 0 and 1) | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | At one month after Nimenrix vaccination (Month 1) | rSBA vaccine response for serogroups A, C, W-135 and Y was defined as: * For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination. * For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination. |
| Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL | Prior to and one month after vaccination with Nimenrix (Months 0 and 1) | The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group. |
| Anti-T Antibody Concentrations | Prior to and one month after vaccination with Nimenrix (Months 0 and 1) | The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group. |
Countries
Dominican Republic, Estonia, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 1, Month 2 and Month 7. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | 259 |
| Nimenrix+Cervarix (0,1,6-Month) Group Subjects in this group received 1 dose of Nimenrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | 259 |
| Cervarix Group Subjects in this group received 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6, administered intramuscularly (IM) in the deltoid region of the arm. | 261 |
| Nimenrix+Cervarix+Boostrix Group Subjects in this group received 1 dose each of Nimenrix and Boostrix vaccines at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. All vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | 260 |
| Boostrix+Cervarix Group Subjects in this group received 1 dose of Boostrix vaccine at Month 0 and 3 doses of Cervarix vaccine at Month 0, Month 1 and Month 6. Both vaccines were administered intramuscularly (IM) in the deltoid region of the arm. | 261 |
| Total | 1,300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 | 0 | 2 |
| Overall Study | Migrated/moved from study area | 0 | 1 | 1 | 1 | 1 |
| Overall Study | Pregnancy | 1 | 1 | 2 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Nimenrix+Cervarix (1,2,7-Month) Group | Nimenrix+Cervarix (0,1,6-Month) Group | Cervarix Group | Nimenrix+Cervarix+Boostrix Group | Boostrix+Cervarix Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 16.3 Participants STANDARD_DEVIATION 4.6 | 16.6 Participants STANDARD_DEVIATION 4.4 | 16.6 Participants STANDARD_DEVIATION 4.6 | 16.6 Participants STANDARD_DEVIATION 4.6 | 16.6 Participants STANDARD_DEVIATION 4.5 | 16.5 Participants STANDARD_DEVIATION 4.5 |
| Race/Ethnicity, Customized Geographic ancestry African Heritage / African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian Heritage | 86 Participants | 86 Participants | 86 Participants | 86 Participants | 86 Participants | 430 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 86 Participants | 87 Participants | 88 Participants | 86 Participants | 87 Participants | 434 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian / European Heritage | 87 Participants | 86 Participants | 87 Participants | 87 Participants | 88 Participants | 435 Participants |
| Sex: Female, Male Female | 259 Participants | 259 Participants | 261 Participants | 260 Participants | 261 Participants | 1300 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 259 | 0 / 259 | 0 / 261 | 0 / 260 | 1 / 261 |
| other Total, other adverse events | 232 / 259 | 228 / 259 | 222 / 261 | 236 / 260 | 243 / 261 |
| serious Total, serious adverse events | 3 / 259 | 2 / 259 | 5 / 261 | 7 / 260 | 6 / 261 |
Outcome results
Primary
Anti-HPV-16 and Anti-HPV-18 Concentrations
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as Enzyme-linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL).
Time frame: At one month after vaccination with Cervarix (Month 7)
Population: The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-16 | 12124.9 EU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-18 | 5234.1 EU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-18 | 5655.0 EU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-16 | 11672.1 EU/mL |
| Nimenrix+Cervarix+Boostrix Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-16 | 9563.8 EU/mL |
| Nimenrix+Cervarix+Boostrix Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-18 | 4306.2 EU/mL |
| Boostrix+Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-16 | 11470.7 EU/mL |
| Boostrix+Cervarix Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-18 | 5110.0 EU/mL |
Comparison: Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-16 titers.95% CI: [0.81, 1.15]ANCOVA
Comparison: Adjusted GMT ratio of the Cervarix Group versus Nimenrix+Cervarix (0,1,6-Month) Group in terms of HPV-18 titers.95% CI: [0.92, 1.29]ANCOVA
Comparison: Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-16 titers.95% CI: [1.01, 1.43]ANCOVA
Comparison: Adjusted GMT ratio of the Boostrix+Cervarix Group versus Nimenrix+Cervarix+Boostrix Group in terms of HPV-18 titers.95% CI: [1, 1.41]ANCOVA
Primary
Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)
The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers, tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement. This analysis was only performed on groups receiving Nimenrix vaccine.
Time frame: At one month after vaccination with Nimenrix (Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 5517.1 Titers |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 4277.3 Titers |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 14782.1 Titers |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 11871.0 Titers |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 12758.9 Titers |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 5523.5 Titers |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 18068.3 Titers |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 5091.0 Titers |
| Nimenrix+Cervarix+Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 11201.2 Titers |
| Nimenrix+Cervarix+Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 3598.6 Titers |
| Nimenrix+Cervarix+Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 11663.6 Titers |
| Nimenrix+Cervarix+Boostrix Group | Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 4649.6 Titers |
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenA titers.95% CI: [0.99, 1.43]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenA titers.95% CI: [0.84, 1.21]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenC titers.95% CI: [0.93, 1.51]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenC titers.95% CI: [0.66, 1.06]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenW-135 titers.95% CI: [0.97, 1.64]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenW-135 titers.95% CI: [0.63, 1.07]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix+Boostrix Group in terms of rSBA-MenY titers.95% CI: [0.89, 1.24]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix Group versus Nimenrix+Cervarix Group in terms of rSBA-MenY titers.95% CI: [0.8, 1.12]ANCOVA
Primary
Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations
The antibody concentrations were tabulated as GMCs and expressed as IU/mL. GMCs were only analyzed in subjects receiving Boostrix vaccination.
Time frame: At one month after Boostrix vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 52.9 IU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 278.7 IU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 193.4 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT | 73.2 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-FHA | 472.4 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-Pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PRN | 318.6 IU/mL |
Comparison: Adjusted GMT ratio of the Nimenrix+Cervarix+Boostrix Group versus Boostrix+ Cervarix Group in terms of anti-PRN titers.95% CI: [1.25, 1.87]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-FHA titers.95% CI: [1.42, 1.93]ANCOVA
Comparison: Adjusted GMT ratio of the Nimenrix+Cervarix Group versus Boostrix+ Cervarix Group in terms of anti-PT titers.95% CI: [1.2, 1.61]ANCOVA
Primary
Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as International Units per milliliter (IU/mL). This analysis was only performed on the groups receiving Boostrix vaccine.
Time frame: At one month after Boostrix vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL | Anti-T | 249 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL | Anti-D | 235 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL | Anti-D | 248 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-diphteria (Anti-D) and Anti-tetanus (Anti-T) Concentrations Equal to or Above (≥) 1.0 IU/mL | Anti-T | 256 Participants |
Comparison: The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-D titers.95% CI: [-6.9, 0.81]
Comparison: The group difference of the Nimenrix+Cervarix+Boostrix Group and Boostrix+Cervarix Group in terms of Anti-T titers.95% CI: [-2.23, 1.08]
Secondary
Anti-D and Anti-T Antibody Concentrations
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Time frame: Prior to and one month after Boostrix vaccination (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, Month 0 | 0.5 IU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, Month 1 | 4.7 IU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, Month 0 | 1.3 IU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, Month 1 | 25.9 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, Month 1 | 15.4 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, Month 0 | 0.5 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-T, Month 0 | 1.3 IU/mL |
| Nimenrix+Cervarix (0,1,6-Month) Group | Anti-D and Anti-T Antibody Concentrations | Anti-D, Month 1 | 6.6 IU/mL |
Secondary
Anti-HPV-16 and Anti-HPV-18 Concentrations
The antibody concentrations were calculated as GMCs and expressed as EU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.
Time frame: Prior to and one month after the third dose of Cervarix (Months 0 and 8)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination from the Nimenrix+Cervarix (1,2,7-Month) Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-16, Month 8 | 11128.2 EU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-18, Month 0 | 9.8 EU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-16, Month 0 | 10.9 EU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-HPV-16 and Anti-HPV-18 Concentrations | Anti-HPV-18, Month 8 | 5357.0 EU/mL |
Secondary
Anti-T Antibody Concentrations
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). This analysis was only performed for the Nimenrix+Cervarix (1,2,7-Month) Group.
Time frame: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-T Antibody Concentrations | Anti-T, Month 0 | 1.2 IU/mL |
| Nimenrix+Cervarix (1,2,7-Month) Group | Anti-T Antibody Concentrations | Anti-T, Month 1 | 25.4 IU/mL |
Secondary
Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Booster responses to the PT, FHA and PRN antigens were defined as: * For initially seronegative subjects (antibody concentrations: \< 2.046 IU/ml for anti-FHA, \< 2.187 IU/ml for anti-PRN, \< 2.693 IU/ml for anti-PT), antibody concentration ≥ 4\*cut\_off IU/ml at Month 1 post-vaccination; * For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration \< 4\*cut\_off IU/ml : antibody concentration at Month 1 ≥ 4 fold the pre-vaccination antibody concentration; * For initially seropositive subjects (antibody concentrations: ≥ 2.046 IU/ml for anti-FHA, ≥ 2.187 IU/ml for anti-PRN, ≥ 2.693 IU/ml for anti-PT) with pre-vaccination antibody concentration ≥ 4\*cut\_off IU/ml : antibody concentration at Month 1 ≥ 2 fold the pre-vaccination antibody concentration.
Time frame: At one month after Boostrix vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA | 240 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT | 218 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN | 231 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PT | 235 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-FHA | 247 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Booster Responses for Anti-PT, Anti-FHA and Anti-PRN Antibodies | Anti-PRN | 248 Participants |
Secondary
Number of Subjects Reporting Solicited General Symptoms
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, rash, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\] and urticaria. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. Some groups do not have results for Dose 2 because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Across doses | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Dose 1 | 23 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 2 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Dose 2 | 3 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 2 | 11 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Dose 1 | 82 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Across doses | 23 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Across doses | 7 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 21 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Across doses | 91 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Across doses | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 19 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Across doses | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Across doses | 95 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Dose 1 | 82 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Dose 1 | 5 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Across doses | 99 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Dose 1 | 81 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Dose 1 | 23 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Across doses | 8 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Dose 1 | 65 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Across doses | 101 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Dose 1 | 60 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Across doses | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Across doses | 34 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Across doses | 26 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Dose 1 | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Across doses | 30 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Across doses | 98 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Dose 1 | 1 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Across doses | 105 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 1 | 24 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Across doses | 34 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 1 | 21 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Dose 2 | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Dose 2 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Dose 2 | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 2 | 10 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Dose 2 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Dose 2 | 3 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Dose 2 | 18 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Dose 2 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Dose 2 | 18 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Dose 2 | 61 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Dose 2 | 2 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Dose 2 | 58 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Dose 2 | 10 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 2 | 1 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Dose 2 | 8 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Dose 2 | 58 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Dose 2 | 3 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Dose 2 | 55 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Dose 2 | 73 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Dose 2 | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Dose 2 | 72 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Across doses | 34 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Dose 1 | 87 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Dose 1 | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Dose 1 | 18 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 27 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Dose 1 | 8 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Across doses | 18 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Across doses | 89 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Across doses | 92 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Dose 1 | 94 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Across doses | 18 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Dose 1 | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Across doses | 31 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Across doses | 32 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Across doses | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Dose 1 | 89 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Across doses | 4 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Across doses | 94 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 1 | 31 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Dose 1 | 81 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Dose 1 | 83 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Across doses | 6 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Dose 1 | 18 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Dose 1 | 95 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Across doses | 27 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 4 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Dose 1 | 6 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Across doses | 8 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 4 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Dose 1 | 92 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Across doses | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Across doses | 81 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Across doses | 95 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 27 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Across doses | 27 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Across doses | 4 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Dose 1 | 4 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Across doses | 4 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 1 | 32 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Across doses | 83 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Dose 1 | 73 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 6 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Dose 1 | 13 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Dose 1 | 13 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Dose 1 | 85 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 2 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Dose 1 | 79 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 23 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 21 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Dose 1 | 5 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Dose 1 | 78 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Dose 1 | 85 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Dose 1 | 82 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Dose 1 | 8 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Dose 1 | 7 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 1 | 15 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 1 | 14 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Dose 1 | 4 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Dose 1 | 4 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Across doses | 13 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 1 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Across doses | 13 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Across doses | 85 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Across doses | 2 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Across doses | 79 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Across doses | 23 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Across doses | 21 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Across doses | 78 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Across doses | 5 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Across doses | 73 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Across doses | 85 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Across doses | 6 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Across doses | 82 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Across doses | 8 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Across doses | 7 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Across doses | 15 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Across doses | 14 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Across doses | 4 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Across doses | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Across doses | 9 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Dose 1 | 6 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 29 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Dose 1 | 99 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Across doses | 92 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Across doses | 99 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Dose 1 | 103 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Across doses | 29 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Dose 1 | 92 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Across doses | 6 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Across doses | 8 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 8 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Across doses | 37 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Dose 1 | 110 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Across doses | 103 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Across doses | 6 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 9 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Dose 1 | 34 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Dose 1 | 36 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Across doses | 92 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 26 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 1 | 37 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Across doses | 36 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Across doses | 96 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Across doses | 26 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 2 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 1 | 38 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Across doses | 38 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Across doses | 34 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Dose 1 | 92 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Dose 1 | 96 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Dose 1 | 6 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Across doses | 110 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Across doses | 27 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Across doses | 101 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Dose 1 | 6 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Dose 1 | 23 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Across doses | 99 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Dose 1 | 100 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Dose 1 | 95 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Across doses | 22 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Dose 1 | 9 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Dose 1 | 101 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Across doses | 20 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Dose 1 | 85 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Headache, Across doses | 95 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Dose 1 | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Headache, Across doses | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Gastrointestinal, Dose 1 | 20 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Across doses | 25 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Headache, Across doses | 85 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Myalgia, Across doses | 101 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Gastrointestinal, Dose 1 | 22 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Across doses | 3 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Myalgia, Across doses | 9 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fatigue, Dose 1 | 99 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Myalgia, Across doses | 100 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fatigue, Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Rash, Across doses | 6 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fatigue, Dose 1 | 101 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Rash, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Dose 1 | 23 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Across doses | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Urticaria, Dose 1 | 3 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Urticaria, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Urticaria, Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Fever, Dose 1 | 25 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Dose 1 | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Arthralgia, Across doses | 23 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Grade 3 Arthralgia, Across doses | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Any Fever, Dose 1 | 27 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Arthralgia, Across doses | 23 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited General Symptoms | Related Rash, Dose 1 | 4 Participants |
Secondary
Number of Subjects Reporting Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. Symptoms were presented by vaccination site. Some groups do not have results for Dose 2 because solicited local symptoms were not collected for these subjects at the Dose 2 timepoint.
Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented, who filled in their symptom sheets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Nimenrix), Across doses | 152 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Nimenrix), Across doses | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Nimenrix), Dose 1 | 57 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Across doses | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Across doses | 193 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Nimenrix), Dose 1 | 152 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Across doses | 15 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Nimenrix), Dose 1 | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Across doses | 43 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Nimenrix), Across doses | 57 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Nimenrix), Across doses | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Nimenrix), Dose 1 | 4 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Across doses | 41 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Nimenrix), Across doses | 1 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Nimenrix), Dose 1 | 40 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Nimenrix), Dose 1 | 1 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Across doses | 1 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Nimenrix), Across doses | 40 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Dose 2 | 193 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Dose 2 | 15 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Dose 2 | 43 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Dose 2 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Dose 2 | 41 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Dose 2 | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Dose 1 | 42 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Across doses | 42 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Nimenrix), Across doses | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Dose 1 | 213 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Nimenrix), Dose 1 | 42 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Nimenrix), Dose 1 | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Across doses | 213 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Across doses | 56 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Nimenrix), Dose 1 | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Across doses | 8 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Nimenrix), Across doses | 34 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Across doses | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Nimenrix), Across doses | 42 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Nimenrix), Across doses | 2 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Dose 1 | 8 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Dose 1 | 56 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Nimenrix), Dose 1 | 2 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Nimenrix), Across doses | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Dose 1 | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Across doses | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Dose 1 | 1 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Nimenrix), Across doses | 140 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Nimenrix), Dose 1 | 140 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Nimenrix), Dose 1 | 34 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Dose 1 | 37 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Across doses | 1 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Dose 1 | 11 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Dose 1 | 54 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Across doses | 205 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Across doses | 37 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Dose 1 | 205 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Dose 1 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Dose 1 | 1 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Across doses | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Across doses | 11 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Across doses | 54 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Dose 1 | 62 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Nimenrix), Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Nimenrix), Dose 1 | 156 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Nimenrix), Dose 1 | 7 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Boostrix), Dose 1 | 189 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Boostrix), Dose 1 | 21 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Dose 1 | 217 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Dose 1 | 23 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Nimenrix), Dose 1 | 54 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Boostrix), Dose 1 | 73 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Boostrix), Dose 1 | 2 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Dose 1 | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Nimenrix), Dose 1 | 58 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Nimenrix), Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Boostrix), Dose 1 | 79 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Boostrix), Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Dose 1 | 64 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Dose 1 | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Nimenrix), Across doses | 156 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Nimenrix), Across doses | 7 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Boostrix), Across doses | 189 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Boostrix), Across doses | 21 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Across doses | 217 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Across doses | 23 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Nimenrix), Across doses | 54 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Nimenrix), Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Boostrix), Across doses | 73 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Boostrix), Across doses | 2 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Across doses | 62 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Across doses | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Nimenrix), Across doses | 58 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Nimenrix), Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Boostrix), Across doses | 79 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Boostrix), Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Across doses | 64 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Across doses | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Dose 1 | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Dose 1 | 55 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Cervarix), Across doses | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Across doses | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Boostrix), Dose 1 | 7 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Boostrix), Dose 1 | 58 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Cervarix), Across doses | 55 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Cervarix), Dose 1 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Dose 1 | 48 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Dose 1 | 221 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Boostrix), Dose 1 | 15 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Swelling (Boostrix), Across doses | 58 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Boostrix), Dose 1 | 200 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling (Boostrix), Across doses | 7 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Boostrix), Dose 1 | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Boostrix), Across doses | 53 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Boostrix), Dose 1 | 53 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness (Boostrix), Across doses | 4 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Across doses | 18 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Cervarix), Across doses | 221 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Boostrix), Across doses | 15 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain (Cervarix), Dose 1 | 18 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Redness (Cervarix), Across doses | 48 Participants |
| Boostrix+Cervarix Group | Number of Subjects Reporting Solicited Local Symptoms | Any Pain (Boostrix), Across doses | 200 Participants |
Secondary
Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies
Seroconversion rate is defined as the appearance of antibodies (i.e. titers greater than or equal to the cut-off value) in the serum of subjects who are seronegative before vaccination. The antibody concentrations were calculated as GMCs and expressed as EU/mL.
Time frame: Prior to and one month after the third dose of Cervarix (Month 0 and Month 7/Month 8)
Population: The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 0 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 7/Month 8 | 228 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 0 | 0 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 7/Month 8 | 234 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 0 | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 7/Month 8 | 236 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 7/Month 8 | 219 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 0 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 7/Month 8 | 232 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 7/Month 8 | 217 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 0 | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 0 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 0 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 7/Month 8 | 215 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 7/Month 8 | 230 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 0 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 7/Month 8 | 233 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-18, Month 0 | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 7/Month 8 | 225 Participants |
| Boostrix+Cervarix Group | Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies | Anti-HPV-16, Month 0 | 0 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL).
Time frame: Prior to and one month after Boostrix vaccination (Month 0 and Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-D, Month 0 | 214 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-D, Month 1 | 250 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-T, Month 0 | 239 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-T, Month 1 | 250 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-T, Month 1 | 256 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-D, Month 0 | 223 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-T, Month 0 | 248 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-D, Month 1 | 256 Participants |
Secondary
Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL
The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as ELISA units per milliliter (EU/mL).
Time frame: Prior to the first dose and one month after the third dose of Cervarix [Month 0 and Month 7/Month 8 in Nimenrix+Cervarix (1,2,7-Month) Group]
Population: The analysis was performed on the ATP cohort for immunogenicity after Cervarix vaccination, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one HPV antigen component for the blood sample taken one month after the last Cervarix vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 0 | 17 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 7/Month 8 | 245 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 0 | 11 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 7/Month 8 | 245 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 0 | 29 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 7/Month 8 | 248 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 7/Month 8 | 248 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 0 | 12 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 7/Month 8 | 249 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 7/Month 8 | 249 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 0 | 17 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 0 | 32 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 0 | 29 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 7/Month 8 | 244 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 7/Month 8 | 244 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 0 | 14 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 7/Month 8 | 247 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-18, Month 0 | 14 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 7/Month 8 | 247 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Anti-HPV-16 Concentrations ≥ 19 EU/mL and Anti-HPV-18 Concentrations ≥ 18 EU/mL | Anti-HPV-16, Month 0 | 22 Participants |
Secondary
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value
The antibody concentrations were calculated as GMCs and expressed as IU/mL. Anti-PT assay cut-off=2.693 IU/mL, anti-FHA assay cut-off=2.046 IU/mL, anti-PRN assay cut-off=2.187 IU/mL.
Time frame: Prior to and one month after Boostrix vaccination (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Boostrix.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PT, Month 1 | 240 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PT, Month 0 | 156 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PRN, Month 0 | 218 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-FHA, Month 0 | 235 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PRN, Month 1 | 246 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-FHA, Month 1 | 247 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PRN, Month 1 | 256 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PT, Month 0 | 153 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PT, Month 1 | 252 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-FHA, Month 0 | 244 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-FHA, Month 1 | 256 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Equal to or Above the Cut-off Value | Anti-PRN, Month 0 | 229 Participants |
Secondary
Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL
The antibody concentrations were tabulated as GMCs and expressed as IU/mL, only for the Nimenrix+Cervarix (1,2,7-Month) Group.
Time frame: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity,which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after Nimenrix vaccination,only for Nimenrix+Cervarix (1,2,7-Month) Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL | Anti-T ≥ 1 IU/mL, Month 0 | 151 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL | Anti-T ≥ 1 IU/mL, Month 1 | 253 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL | Anti-T ≥ 0.1 IU/mL, Month 0 | 236 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Anti-T Antibody Concentrations ≥ 0.1 IU/mL and ≥ 1.0 IU/mL | Anti-T ≥ 0.1 IU/mL, Month 1 | 255 Participants |
Secondary
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the entire study period (from Month 0 to Month 8)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 1 Participants |
| Boostrix+Cervarix Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects With New Onset Chronic Illnesses (NOCIs) | 2 Participants |
Secondary
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time frame: During the entire study period (from Month 0 to Month 8)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128
The number of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY antibody titers ≥ 1:8 and ≥ 1:128 prior to and one month after vaccination with Nimenrix vaccine.
Time frame: Prior to and one month after vaccination with Nimenrix (Months 0 and 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:8, Month 1 | 254 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:8, Month 0 | 86 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:128, Month 1 | 255 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:8, Month 1 | 255 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:128, Month 0 | 78 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:8, Month 1 | 256 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:128, Month 0 | 84 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:128, Month 0 | 20 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:128, Month 1 | 256 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:128, Month 0 | 22 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:8, Month 0 | 34 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:8, Month 0 | 112 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:128, Month 1 | 254 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:8, Month 1 | 253 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:8, Month 0 | 23 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:128, Month 1 | 253 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:8, Month 1 | 253 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:8, Month 0 | 29 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:8, Month 1 | 255 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:128, Month 1 | 255 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:128, Month 1 | 255 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:8, Month 0 | 118 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:8, Month 0 | 24 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:8, Month 0 | 102 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:128, Month 0 | 86 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:128, Month 0 | 10 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:128, Month 0 | 23 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:128, Month 0 | 99 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:8, Month 1 | 255 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:8, Month 1 | 255 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:128, Month 1 | 252 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:128, Month 1 | 255 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:128, Month 1 | 252 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:8, Month 1 | 255 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:8, Month 0 | 22 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:8, Month 0 | 129 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:8, Month 1 | 253 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:8, Month 0 | 40 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:128, Month 1 | 250 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenC ≥1:128, Month 0 | 23 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:8, Month 1 | 255 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:128, Month 1 | 255 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:8, Month 1 | 250 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenW-135 ≥1:128, Month 0 | 20 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenA ≥1:128, Month 0 | 82 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:128, Month 1 | 255 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:128, Month 0 | 74 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres ≥ 1:8 and ≥ 1:128 | rSBA-MenY ≥1:8, Month 0 | 80 Participants |
Secondary
Number of Subjects With Serious Adverse Events SAE(s)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (from Month 0 to Month 8)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Serious Adverse Events SAE(s) | 3 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Serious Adverse Events SAE(s) | 2 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Serious Adverse Events SAE(s) | 5 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Serious Adverse Events SAE(s) | 7 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Serious Adverse Events SAE(s) | 6 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events AE(s)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any 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 assessed by the investigator as related to the vaccination.
Time frame: During the 31-day (Days 0-30) period following vaccination with Nimenrix, Boostrix or the first dose of Cervarix
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 37 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 35 Participants |
| Nimenrix+Cervarix+Boostrix Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 35 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 42 Participants |
| Boostrix+Cervarix Group | Number of Subjects With Unsolicited Adverse Events AE(s) | 39 Participants |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response
rSBA vaccine response for serogroups A, C, W-135 and Y was defined as: * For initially seronegative subjects (pre-vaccination titre below the cut-off of 1:8): number of subjects with rSBA antibody titres ≥ 1:32 one month after vaccination. * For initially seropositive subjects (pre-vaccination titre ≥ 1:8): number of subjects with rSBA antibody titres at least four times the pre-vaccination antibody titres, one month after vaccination.
Time frame: At one month after Nimenrix vaccination (Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects from the ATP cohort for safety for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after vaccination with Nimenrix.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix+Cervarix (1,2,7-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenA | 240 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenC | 250 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenW-135 | 252 Participants |
| Nimenrix+Cervarix (1,2,7-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenY | 245 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenY | 253 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenA | 235 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenW-135 | 255 Participants |
| Nimenrix+Cervarix (0,1,6-Month) Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenC | 251 Participants |
| Nimenrix+Cervarix+Boostrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenY | 251 Participants |
| Nimenrix+Cervarix+Boostrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenC | 246 Participants |
| Nimenrix+Cervarix+Boostrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenW-135 | 248 Participants |
| Nimenrix+Cervarix+Boostrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Vaccine Response | rSBA-MenA | 230 Participants |