Infections, Meningococcal
Conditions
Keywords
Meningococcal vaccines, Vaccines, conjugate, Neisseria meningitidis, Immunocompromised patient
Brief summary
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new meningococcal vaccine 134612 in subjects with increased risk of meningococcal disease and compare it to its activity in healthy subjects.
Detailed description
For each at risk subject enrolled, an age-matched healthy subject will be enrolled. Age matching will be performed according to the following age strata: 1-5 years, 6-10 years, 11-17 years.
Interventions
BIOLOGICALMeningococcal vaccine GSK134612
2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A male or female 1 to 17 years of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/LAR(s) of the subject and informed assent obtained from the subject, if appropriate, prior to enrolment. * Female subjects of non-childbearing potential may be enrolled in the study. * Female subjects of childbearing potential may be enrolled in the study, if * the subject has practiced adequate contraception for one month (30 days) prior to the first vaccine dose, and * has a negative pregnancy test on the day of vaccination, and * has agreed to continue adequate contraception from administration of the first vaccine dose until 2 months after administration of the second vaccine dose. Additional inclusion criterion for At-risk group • Subjects with an increased risk for meningococcal disease, such as anatomic asplenia or some degree of functional asplenia or complement deficiencies. Additional inclusion criteria for Healthy group * Healthy subject as established by medical history and clinical examination before entering into the study. * Age-matched to a subject from the At-risk group according to age strata 1-5 years, 6-10 years and 11 to 17 years.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (until the phone contact at Month 8). * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before administration of each study vaccine dose until 30 days after administration of each study vaccine dose. Administration of licensed inactivated influenza vaccines is allowed as per local recommendations. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * History of meningococcal disease. * Any confirmed or suspected Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine until one month after the second dose of study vaccine. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine including latex. * Major congenital defects. * History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted. * Acute disease and/or fever at the time of enrolment. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | One month after the first vaccine dose (at Month 1) | Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects \[i.e. pre-vaccination rSBA antibody titers below (\<) 1:8\] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8). |
| Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | One month after the first vaccine dose (at Month 1) | Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3) | The cut-off value for the assay was ≥ 1:8. |
| Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) | Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects. |
| Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) | The cut-off value for the assay was ≥ 1:4. |
| Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3 | Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects. |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) | The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m). |
| Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3) | The cut-off value for the assay was ≥ 2.0 μg/mL. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | During the 4-day (Days 0-3) 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 = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
| Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | One month after the second vaccine dose (At Month 3) | Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8). |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature \>39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature \>39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8) | NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies. |
| Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post first vaccination period | An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. |
| Number of Subjects Reporting Any Unsolicited AEs | During the 31-day (Days 0-30) post second vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Month 0 until the end of the ESFU (at Month 8) | Serious adverse events (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 Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | During the 4-day (Days 0-3) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
| Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | One month after the second vaccine dose (At Month 3) | Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4). |
Countries
Czechia, United States
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix At-Risk Group Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. | 43 |
| Nimenrix Healthy Group Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. | 43 |
| Total | 86 |
Baseline characteristics
| Characteristic | Nimenrix At-Risk Group | Nimenrix Healthy Group | Total |
|---|---|---|---|
| Age, Continuous | 12.0 Years STANDARD_DEVIATION 4.4 | 11.5 Years STANDARD_DEVIATION 3.6 | 11.75 Years STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized African Heritage/African American | 11 Participants | 2 Participants | 13 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White-Caucasian/European Heritage | 32 Participants | 38 Participants | 70 Participants |
| Sex: Female, Male Female | 20 Participants | 22 Participants | 42 Participants |
| Sex: Female, Male Male | 23 Participants | 21 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 38 / 43 | 34 / 43 |
| serious Total, serious adverse events | 4 / 43 | 1 / 43 |
Outcome results
Primary
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies
Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Time frame: One month after the first vaccine dose (at Month 1)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenA | 23 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenC | 27 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenW-135 | 20 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenY | 23 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenY | 29 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenA | 23 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenW-135 | 21 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies | hSBA-MenC | 20 Participants |
Primary
Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies
Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects \[i.e. pre-vaccination rSBA antibody titers below (\<) 1:8\] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Time frame: One month after the first vaccine dose (at Month 1)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenA | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenC | 37 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenW-135 | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenY | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenY | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenA | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenW-135 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies | rSBA-MenC | 39 Participants |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSA; Month 0 | 1.9 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSA; Month 1 | 17.4 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSA; Month 3 | 14.2 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSC; Month 0 | 0.4 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSC; Month 1 | 8.3 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSC; Month 3 | 6 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSW-135; Month 0 | 0.6 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSW-135; Month 1 | 14.9 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSW-135; Month 3 | 19 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSY; Month 0 | 2.9 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSY; Month 1 | 20.4 Titers |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSY; Month 3 | 30 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSY; Month 1 | 17.3 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSA; Month 0 | 1.4 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSW-135; Month 0 | 0.4 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSA; Month 1 | 16.2 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSY; Month 0 | 2.5 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSA; Month 3 | 10.7 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSW-135; Month 1 | 13.3 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSC; Month 0 | 0.2 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSY; Month 3 | 12.5 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSC; Month 1 | 8.4 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSW-135; Month 3 | 14 Titers |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | anti-PSC; Month 3 | 5.8 Titers |
Secondary
Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.
Time frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenA; Month 0 | 5.5 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenA; Month 1 | 105.9 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenA; Month 3 | 235.1 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenC; Month 0 | 12.9 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenC; Month 1 | 812.9 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenC; Month 3 | 1472.1 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenW-135; Month 0 | 21.7 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenW-135; Month 1 | 283.7 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenW-135; Month 3 | 884.5 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenY; Month 0 | 37 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenY; Month 1 | 743.6 Titres |
| Nimenrix At-Risk Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenY; Month 3 | 1415.1 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenY; Month 1 | 661.7 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenA; Month 0 | 4.2 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenW-135; Month 0 | 13.6 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenA; Month 1 | 68.7 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenY; Month 0 | 32 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenA; Month 3 | 90.3 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenW-135; Month 1 | 263.7 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenC; Month 0 | 10.9 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenY; Month 3 | 800.7 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenC; Month 1 | 196.7 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenW-135; Month 3 | 590.8 Titres |
| Nimenrix Healthy Group | Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens | hSBA-MenC; Month 3 | 764.6 Titres |
Secondary
Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens
Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.
Time frame: At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenA; Month 0 | 8.6 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenA; Month 1 | 2012.8 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenA; Month 3 | 2820.1 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenC; Month 0 | 9 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenC; Month 1 | 1374.8 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenC; Month 3 | 1684.3 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenW-135; Month 0 | 7 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenW-135; Month 1 | 3050.9 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenW-135; Month 3 | 5844.3 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenY; Month 0 | 10.6 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenY; Month 1 | 4624.2 Titers |
| Nimenrix At-Risk Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenY; Month 3 | 5640.2 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenY; Month 1 | 7009 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenA; Month 0 | 4.8 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenW-135; Month 0 | 5.1 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenA; Month 1 | 4025.6 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenY; Month 0 | 9.7 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenA; Month 3 | 3553.1 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenW-135; Month 1 | 4167.6 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenC; Month 0 | 6.3 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenY; Month 3 | 6618.6 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenC; Month 1 | 2233.4 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenW-135; Month 3 | 6981.1 Titers |
| Nimenrix Healthy Group | Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens | rSBA-MenC; Month 3 | 1684.3 Titers |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Pain, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Pain, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Redness, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Redness, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Swelling, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Swelling, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Pain, Dose 2 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Pain, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Redness, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Redness, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Swelling, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Swelling, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Pain, Across Doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Pain, Across Doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Redness, Across Doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Redness, Across Doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Swelling, Across Doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Swelling, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Pain, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Pain, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Redness, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Pain, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Swelling, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Redness, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Swelling, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Redness, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Redness, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Swelling, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Swelling, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Swelling, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Swelling, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Pain, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Pain, Across Doses | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Pain, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Grade 3 Redness, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years | Any Redness, Dose 2 | 0 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years
Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Pain, Dose 1 | 28 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Pain, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Redness, Dose 1 | 7 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Redness, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Swelling, Dose 1 | 12 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Swelling, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Pain, Dose 2 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Pain, Dose 2 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Redness, Dose 2 | 12 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Redness, Dose 2 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Swelling, Dose 2 | 12 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Swelling, Dose 2 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Pain, Across Doses | 32 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Pain, Across Doses | 4 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Redness, Across Doses | 14 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Redness, Across Doses | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Swelling, Across Doses | 18 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Swelling, Across Doses | 4 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Pain, Across Doses | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Pain, Dose 1 | 23 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Redness, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Pain, Dose 1 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Swelling, Across Doses | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Redness, Dose 1 | 13 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Swelling, Dose 2 | 10 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Redness, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Redness, Across Doses | 14 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Swelling, Dose 1 | 8 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Swelling, Dose 2 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Swelling, Dose 1 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Swelling, Across Doses | 12 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Pain, Dose 2 | 24 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Pain, Across Doses | 28 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Pain, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Grade 3 Redness, Across Doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years | Any Redness, Dose 2 | 8 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature \>39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Irritability, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Irritability, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Fever, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Fever, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Fever, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Loss of appetite, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Fever, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Drowsiness, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Drowsiness, Across doses | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Drowsiness, Dose 1 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Drowsiness, Across doses | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Drowsiness, Across doses | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Irritability, Across doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Drowsiness, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Irritability, Across doses | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Irritability, Dose 1 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Irritability, Across doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Irritability, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Loss of appetite, Across doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Loss of appetite, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Loss of appetite, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Irritability, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Loss of appetite, Across doses | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Drowsiness, Dose 1 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Fever, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Irritability, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Fever, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Fever, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Fever, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Drowsiness, Dose 1 | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Fever, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Drowsiness, Dose 1 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Drowsiness, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Irritability, Dose 1 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Irritability, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Irritability, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Loss of appetite, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Loss of appetite, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Fever, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Fever, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Drowsiness, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Drowsiness, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Irritability, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Irritability, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Irritability, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Loss of appetite, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Fever, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Fever, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Fever, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Drowsiness, Across doses | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Drowsiness, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Drowsiness, Across doses | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Irritability, Across doses | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Irritability, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Irritability, Across doses | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Loss of appetite, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Loss of appetite, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Related Loss of appetite, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Any Fever, Across doses | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years | Grade 3 Fever, Across doses | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature \>39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Headache, Dose 2 | 7 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Gastrointestinal, Dose 1 | 4 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Headache, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Headache, Dose 2 | 6 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Gastrointestinal, Dose 1 | 5 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fever, Dose 2 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fever, Dose 1 | 2 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fever, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Headache, Dose 1 | 12 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fever, Dose 2 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fatigue, Dose 2 | 13 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fatigue, Across doses | 21 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fatigue, Dose 1 | 17 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fatigue, Across doses | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fatigue, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fatigue, Across doses | 21 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Headache, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Gastrointestinal, Across doses | 6 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fatigue, Dose 2 | 13 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Gastrointestinal, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Gastrointestinal, Across doses | 5 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Gastrointestinal, Dose 2 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Headache, Across doses | 16 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Headache, Dose 1 | 9 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Headache, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Gastrointestinal, Dose 2 | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Headache, Across doses | 14 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fatigue, Dose 1 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fever, Across doses | 4 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Gastrointestinal, Dose 2 | 1 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fever, Across doses | 0 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fever, Dose 1 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fever, Across doses | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fatigue, Dose 1 | 18 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fever, Across doses | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fatigue, Dose 1 | 12 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fatigue, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fatigue, Dose 1 | 12 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Gastrointestinal, Dose 1 | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Gastrointestinal, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Gastrointestinal, Dose 1 | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Headache, Dose 1 | 9 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Headache, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Headache, Dose 1 | 9 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fever, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fever, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fever, Dose 1 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fatigue, Dose 2 | 7 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fatigue, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fatigue, Dose 2 | 6 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Gastrointestinal, Dose 2 | 6 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Gastrointestinal, Dose 2 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Gastrointestinal, Dose 2 | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Headache, Dose 2 | 5 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Headache, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Headache, Dose 2 | 4 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fever, Dose 2 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fever, Dose 2 | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fever, Dose 2 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fatigue, Across doses | 14 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fatigue, Across doses | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Fatigue, Across doses | 14 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Gastrointestinal, Across doses | 8 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Gastrointestinal, Across doses | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Gastrointestinal, Across doses | 5 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Headache, Across doses | 10 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Headache, Across doses | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Related Headache, Across doses | 10 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Any Fever, Across doses | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years | Grade 3 Fever, Across doses | 0 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Time frame: During the 31-day (Days 0-30) post first vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 7 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any Unsolicited Adverse Events (AEs) | 7 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Time frame: During the 31-day (Days 0-30) post second vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting Any Unsolicited AEs | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting Any Unsolicited AEs | 8 Participants |
Secondary
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Time frame: From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
| Nimenrix Healthy Group | Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values
The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSA; Month 0 | 28 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSA; Month 1 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSA; Month 3 | 33 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSC; Month 0 | 15 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSC; Month 1 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSC; Month 3 | 33 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSW-135; Month 0 | 21 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSW-135; Month 1 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSW-135; Month 3 | 33 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSY; Month 0 | 7 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSY; Month 1 | 10 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSY; Month 3 | 10 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSY; Month 1 | 13 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSA; Month 0 | 30 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSW-135; Month 0 | 19 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSA; Month 1 | 34 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSY; Month 0 | 5 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSA; Month 3 | 32 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSW-135; Month 1 | 34 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSC; Month 0 | 4 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSY; Month 3 | 11 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSC; Month 1 | 34 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSW-135; Month 3 | 32 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values | anti-PSC; Month 3 | 32 Participants |
Secondary
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values
The cut-off value for the assay was ≥ 2.0 μg/mL.
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSA; Month 1 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSW-135; Month 0 | 4 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSC; Month 0 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSW-135; Month 1 | 28 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSA; Month 0 | 12 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSW-135; Month 3 | 33 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSC; Month 1 | 26 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSY; Month 0 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSY; Month 1 | 10 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSA; Month 3 | 33 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSY; Month 3 | 10 Participants |
| Nimenrix At-Risk Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSC; Month 3 | 30 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSY; Month 3 | 11 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSA; Month 0 | 9 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSA; Month 1 | 34 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSA; Month 3 | 32 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSC; Month 0 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSC; Month 1 | 32 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSC; Month 3 | 27 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSW-135; Month 0 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSW-135; Month 1 | 33 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSW-135; Month 3 | 32 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSY; Month 1 | 13 Participants |
| Nimenrix Healthy Group | Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values | anti-PSY; Month 0 | 3 Participants |
Secondary
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Time frame: One month after the second vaccine dose (At Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenY | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenA | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenW-135 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies | rSBA-MenC | 39 Participants |
Secondary
Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers \< 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Time frame: One month after the second vaccine dose (At Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA | 28 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC | 34 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY | 27 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY | 27 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA | 24 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 | 24 Participants |
| Nimenrix Healthy Group | Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC | 29 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay was ≥ 1:4.
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 0 | 14 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 1 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 3 | 35 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 0 | 21 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 1 | 34 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 3 | 38 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 0 | 20 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 1 | 34 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 0 | 24 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 1 | 37 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 1 | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 0 | 12 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 0 | 16 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 1 | 28 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 0 | 25 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 3 | 29 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 1 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 0 | 23 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 1 | 36 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 3 | 38 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 3 | 39 Participants |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay ≥ 1:8.
Time frame: Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 0 | 20 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 1 | 29 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 1 | 34 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 0 | 20 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 0 | 13 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 0 | 24 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 1 | 34 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 1 | 37 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 3 | 35 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 3 | 38 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 0 | 12 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 1 | 28 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenA; Month 3 | 29 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 0 | 22 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 1 | 36 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 0 | 16 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 1 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenW-135; Month 3 | 38 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 0 | 25 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenY; Month 1 | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values | hSBA-MenC; Month 3 | 39 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay was ≥ 1:8.
Time frame: At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 0 | 7 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 1 | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 0 | 10 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 1 | 37 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 0 | 5 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 1 | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 0 | 9 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 1 | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 1 | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 0 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 0 | 3 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 1 | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 0 | 8 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 1 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 0 | 5 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 1 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 3 | 39 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
The cut-off value for the assay was ≥ 1:128.
Time frame: Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 1 | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 0 | 4 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 0 | 3 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 1 | 40 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 0 | 6 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 3 | 38 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 1 | 37 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 0 | 8 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 3 | 38 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 3 | 39 Participants |
| Nimenrix At-Risk Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 1 | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 0 | 1 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 1 | 40 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenA; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 0 | 4 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 1 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenC; Month 3 | 38 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 0 | 2 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 1 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenW-135; Month 3 | 39 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 0 | 8 Participants |
| Nimenrix Healthy Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values | rSBA-MenY; Month 1 | 40 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (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: From Month 0 until the end of the ESFU (at Month 8)
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix At-Risk Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| Nimenrix Healthy Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |