Infections, Meningococcal
Conditions
Keywords
Immunogenicity, Healthy, Persistence, Meningococcal vaccine, Non-inferiority, Meningococcal A C W Y Diseases, meningococcal serogroups A, C, W & Y diseases
Brief summary
Meningococcal disease is mostly caused by N. meningitidis of serogroups A, B, C, W-135, Y. Meningococcal polysaccharide-conjugate vaccines have the advantage to induce a T-cell dependant immune response while the existing polysaccharide vaccines induce a T-cell independent response, i.e. with no immune memory response. GSK Biologicals has developed a combined Men ACWY conjugate vaccine intended to protect against meningococcal disease due to serogroups A, C, W-135 and Y. In the vaccination phase of this study, the new MenACWY-TT conjugate vaccine will be evaluated in adolescents and adults using Mencevax™ ACWY as control. In the long-term follow-up phase (extension phase) of the study, the long-term protection offered by the new MenACWY-TT conjugate vaccine will be assessed up to five years after the vaccination in adolescents and adults using Mencevax™ ACWY as control. This protocol posting deals with objectives & outcome measures of both the primary & extension phases.
Detailed description
All subjects will have 7 blood samples taken: prior to and one month after vaccination and one, two, three, four and five years after vaccination. No new subjects will be enrolled in the extension phases of this Phase IIb study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
Interventions
BIOLOGICALmeningococcal ACWY (vaccine)
One intramuscular dose.
BIOLOGICALMencevax™ ACWY
One subcutaneous dose.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parents/ legally acceptable representative can and will comply with the requirements of the protocol. * A male or female between, and including, 11 and 55 years of age at the time of vaccination. * Written informed consent obtained from the subject/ from the parent or legally acceptable representative of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Previously completed routine childhood vaccinations to the best of his/her knowledge and/or his/her parents/legally acceptable representative's knowledge. * If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, and must agree to continue such precautions for two months after completion of the vaccination series. Female subjects in childbearing potential who are not abstinent must have a negative pregnancy test.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s). * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C W and/or Y within the last five previous years. * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C W and/or Y. * History of meningococcal disease due to serogroup A, C, W or Y. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * History of Guillain-Barré syndrome. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Pregnant or lactating female. * History of chronic alcohol consumption and/or drug abuse. * Female planning to become pregnant or planning to discontinue contraceptive precautions. Specific criteria to be checked at each study visit for the long term follow-up: * History of meningococcal serogroup A,C, W and Y disease. * Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | One month post vaccination | Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination. |
| Occurrence of Any Grade 3 Systemic Symptoms | During the 4-day (Days 0-3) post-vaccination period | Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Prior to and 1 Month after vaccination | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL. |
| Concentration of Anti-PS Antibodies | Prior to and 1 Month after vaccination | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL). |
| Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Prior to and 1 Month after vaccination | Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL). |
| Concentration of Anti-TT Antibodies | Prior to and 1 Month after vaccination | Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL). |
| Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | At Year 1 | The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128. |
| Number of Subjects With Anti-PS Antibodies | At Year 1 | The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. |
| Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | Prior to and 1 Month after vaccination | The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128. |
| Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | From Day 0 up to 6 Months after vaccination | NOCIs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects With Rash | From Day 0 up to 6 Months after vaccination | — |
| Number of Subjects With AEs Resulting in Emergency Rooms Visits | From Day 0 up to 6 Months after vaccination | — |
| Number of Subjects With Unsolicited AEs | Up to 31 Days after vaccination | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 up to 6 Months after vaccination | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With SAEs | At Year 1, Year 2, Year 3, Year 4 and Year 5 | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| rSBA Antibody Titers | Prior to and 1 Month after vaccination | Antibody titers are presented as Geometric Mean Titers (GMTs). |
Countries
Philippines, Saudi Arabia
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 Group Subjects who received one dose of Nimenrix™ vaccine, administrated intramuscularly (IM) in the non-dominant deltoid region. | 374 |
| Mencevax Group Subjects who received one dose of Mencevax™ ACWY vaccine, administrated subcutaneous by injection into the non-dominant upper arm. | 126 |
| Total | 500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Active Phase | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Nimenrix Group | Mencevax Group | Total |
|---|---|---|---|
| Age, Continuous | 18.6 Years STANDARD_DEVIATION 7.62 | 19.3 Years STANDARD_DEVIATION 8.58 | 18.78 Years STANDARD_DEVIATION 7.86 |
| Race/Ethnicity, Customized Geographic ancestry Asian-East Asian heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian-South East Asian heritage | 298 Participants | 101 Participants | 399 Participants |
| Race/Ethnicity, Customized Geographic ancestry White-Arabic/North African heritage | 75 Participants | 25 Participants | 100 Participants |
| Sex: Female, Male Female | 168 Participants | 60 Participants | 228 Participants |
| Sex: Female, Male Male | 206 Participants | 66 Participants | 272 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 374 | 0 / 126 |
| other Total, other adverse events | 186 / 374 | 53 / 126 |
| serious Total, serious adverse events | 1 / 374 | 0 / 126 |
Outcome results
Primary
Occurrence of Any Grade 3 Systemic Symptoms
Local symptom, Grade 3 = pain that prevented normal activity and redness/ swelling spreading beyond (\>) 50 millimeters (mm). General symptom, Grade 3 = symptom that prevented normal activity and fever (orally) \>39.5 °C.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Occurrence of Any Grade 3 Systemic Symptoms | Any Grade 3 unsolicited | 12 Participants |
| Nimenrix Group | Occurrence of Any Grade 3 Systemic Symptoms | Grade 3 solicited general | 5 Participants |
| Nimenrix Group | Occurrence of Any Grade 3 Systemic Symptoms | Grade 3 solicited local | 9 Participants |
| Mencevax Group | Occurrence of Any Grade 3 Systemic Symptoms | Any Grade 3 unsolicited | 1 Participants |
| Mencevax Group | Occurrence of Any Grade 3 Systemic Symptoms | Grade 3 solicited general | 0 Participants |
| Mencevax Group | Occurrence of Any Grade 3 Systemic Symptoms | Grade 3 solicited local | 1 Participants |
Comparison: To evaluate the non-inferiority of the MenACWY-TT conjugate vaccine when compared to the licensed MenACWY vaccine in terms of the incidence of any Grade 3 systemic symptom within 4 days after vaccination.95% CI: [-1.64, 3.09]
Primary
Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA)
Response to vaccine antigen was defined as: for initially seronegative subjects \[subjects with serum bactericidal assay using rabbit complement (rSBA) titer lower than (\<) 1:8, post-vaccination rSBA titer greater than or equal to (≥) 1:32\] and for initially seropositive (subjects with rSBA titer ≥ 1:8), at least 4-fold increase in rSBA titer from pre to post vaccination.
Time frame: One month post vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 82.7 Percentage of subjects |
| Nimenrix Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 94.4 Percentage of subjects |
| Nimenrix Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 96.3 Percentage of subjects |
| Nimenrix Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 93 Percentage of subjects |
| Mencevax Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenY | 85 Percentage of subjects |
| Mencevax Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenA | 69.7 Percentage of subjects |
| Mencevax Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenW-135 | 91.7 Percentage of subjects |
| Mencevax Group | Vaccine Response to Meningococcal Antigens for Serum Bactericidal Assay Using Rabbit Complement (rSBA) | rSBA-MenC | 90.3 Percentage of subjects |
Comparison: To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.95% CI: [3.52, 23.5]
Comparison: To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.95% CI: [-1.03, 11.36]
Comparison: To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.95% CI: [-0.07, 11.49]
Comparison: To evaluate the non-inferiority of the vaccine response\* induced by the MenACWY-TT vaccine when compared to the licensed MenACWY vaccine.95% CI: [1.72, 16.17]
Secondary
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time frame: At Year 3
Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M36]) | 2.7 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M36]) | 12.5 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M36]) | 2.9 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M36]) | 3.8 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M36]) | 8.2 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M36]) | 5.5 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M36]) | 19.8 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M36]) | 13.9 μg/mL |
Secondary
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time frame: At Year 2
Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point..
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M24]) | 15.15 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M24]) | 2.62 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M24]) | 3.51 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M24]) | 4.44 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M24]) | 11.11 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M24]) | 24.85 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M24]) | 6.76 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M24]) | 15.74 μg/mL |
Secondary
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in micrograms/milliliter (µg/mL).
Time frame: Prior to and 1 Month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSA (PRE) | 1.4 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M1]) | 107.3 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSC (PRE) | 0.3 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M1]) | 23.9 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PRE) | 0.2 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M1]) | 18.6 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSY (PRE) | 0.2 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M1]) | 23.2 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M1]) | 23.6 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSA (PRE) | 1.7 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PRE) | 0.2 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M1]) | 53.6 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSY (PRE) | 0.2 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSC (PRE) | 0.3 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M1]) | 15.8 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M1]) | 43.9 μg/mL |
Secondary
Concentration of Anti-PS Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) and measured in µg/mL.
Time frame: At Year 1
Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M12]) | 23.25 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M12]) | 4.67 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M12]) | 5.48 μg/mL |
| Nimenrix Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M12]) | 6.68 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSY (PI [M12]) | 16.7 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSA (PI [M12]) | 31.72 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSW-135 (PI [M12]) | 10.39 μg/mL |
| Mencevax Group | Concentration of Anti-PS Antibodies | Anti-PSC (PI [M12]) | 24.53 μg/mL |
Secondary
Concentration of Anti-TT Antibodies
Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).
Time frame: Prior to and 1 Month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Concentration of Anti-TT Antibodies | Anti-TT (PRE) | 0.35 IU/mL |
| Nimenrix Group | Concentration of Anti-TT Antibodies | Anti-TT (PI [M1]) | 10.01 IU/mL |
| Mencevax Group | Concentration of Anti-TT Antibodies | Anti-TT (PRE) | 0.28 IU/mL |
| Mencevax Group | Concentration of Anti-TT Antibodies | Anti-TT (PI [M1]) | 0.27 IU/mL |
Secondary
Number of Subjects With AEs Resulting in Emergency Rooms Visits
Time frame: From Day 0 up to 6 Months after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With AEs Resulting in Emergency Rooms Visits | 0 Participants |
| Mencevax Group | Number of Subjects With AEs Resulting in Emergency Rooms Visits | 0 Participants |
Secondary
Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time frame: Prior to and 1 Month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PRE) ≥ 0.3 μg/mL | 255 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PI [M1]) ≥ 0.3 μg/mL | 339 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PRE) ≥ 2.0 μg/mL | 137 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PI [M1]) ≥ 2.0 μg/mL | 339 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PRE) ≥ 0.3 μg/mL | 71 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PI [M1]) ≥ 0.3 μg/mL | 340 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PRE) ≥ 2.0 μg/mL | 30 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PI [M1]) ≥ 2.0 μg/mL | 333 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PRE) ≥ 0.3 μg/mL | 41 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PI [M1]) ≥ 0.3 μg/mL | 335 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PRE) ≥ 2.0 μg/mL | 11 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PI [M1]) ≥ 2.0 μg/mL | 314 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PRE) ≥ 0.3 μg/mL | 55 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PI [M1]) ≥ 0.3 μg/mL | 338 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PRE) ≥ 2.0 μg/mL | 25 Participants |
| Nimenrix Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PI [M1]) ≥ 2.0 μg/mL | 328 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PI [M1]) ≥ 2.0 μg/mL | 109 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PRE) ≥ 0.3 μg/mL | 90 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PRE) ≥ 0.3 μg/mL | 17 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PI [M1]) ≥ 0.3 μg/mL | 113 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PRE) ≥ 0.3 μg/mL | 23 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PRE) ≥ 2.0 μg/mL | 53 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PI [M1]) ≥ 0.3 μg/mL | 113 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSA (PI [M1]) ≥ 2.0 μg/mL | 113 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PRE) ≥ 2.0 μg/mL | 8 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PRE) ≥ 0.3 μg/mL | 27 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PRE) ≥ 2.0 μg/mL | 4 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PI [M1]) ≥ 0.3 μg/mL | 114 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSY (PI [M1]) ≥ 0.3 μg/mL | 112 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PRE) ≥ 2.0 μg/mL | 16 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSW-135 (PI [M1]) ≥ 2.0 μg/mL | 106 Participants |
| Mencevax Group | Number of Subjects With Anti-Polysaccharide (Anti-PS) Antibodies | Anti-PSC (PI [M1]) ≥ 2.0 μg/mL | 113 Participants |
Secondary
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL) and ≥ 2.0 μg/mL.
Time frame: At Year 3
Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M36]) ≥ 0.3 μg/mL | 328 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M36]) ≥ 2.0 μg/mL | 300 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M36]) ≥ 0.3 μg/mL | 318 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M36]) ≥ 2.0 μg/mL | 200 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M36]) ≥ 0.3 μg/mL | 303 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M36]) ≥ 2.0 μg/mL | 204 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M36]) ≥ 0.3 μg/mL | 299 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M36]) ≥ 2.0 μg/mL | 213 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M36]) ≥ 2.0 μg/mL | 92 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M36]) ≥ 0.3 μg/mL | 109 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M36]) ≥ 0.3 μg/mL | 105 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M36]) ≥ 2.0 μg/mL | 108 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M36]) ≥ 0.3 μg/mL | 108 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M36]) ≥ 0.3 μg/mL | 110 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M36]) ≥ 2.0 μg/mL | 87 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M36]) ≥ 2.0 μg/mL | 106 Participants |
Secondary
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Time frame: At Year 1
Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M12]) ≥ 0.3 μg/mL | 351 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M12]) ≥ 2.0 μg/mL | 332 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M12]) ≥ 0.3 μg/mL | 349 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M12]) ≥ 2.0 μg/mL | 262 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M12]) ≥ 0.3 μg/mL | 342 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M12]) ≥ 2.0 μg/mL | 264 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M12]) ≥ 0.3 μg/mL | 350 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M12]) ≥ 2.0 μg/mL | 289 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M12]) ≥ 2.0 μg/mL | 110 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M12]) ≥ 0.3 μg/mL | 116 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M12]) ≥ 0.3 μg/mL | 112 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M12]) ≥ 2.0 μg/mL | 115 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M12]) ≥ 0.3 μg/mL | 116 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M12]) ≥ 0.3 μg/mL | 117 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M12]) ≥ 2.0 μg/mL | 102 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M12]) ≥ 2.0 μg/mL | 113 Participants |
Secondary
Number of Subjects With Anti-PS Antibodies
The cut-off value for the anti-PS concentration was greater than or equal to (≥) 0.3 μg/mL and ≥ 2.0 μg/mL.
Time frame: At Year 2
Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M24]) ≥ 0.3 μg/mL | 335 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M24]) ≥ 2.0 μg/mL | 301 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M24]) ≥ 0.3 μg/mL | 323 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M24]) ≥ 2.0 μg/mL | 196 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M24]) ≥ 0.3 μg/mL | 316 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M24]) ≥ 2.0 μg/mL | 226 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M24]) ≥ 0.3 μg/mL | 325 Participants |
| Nimenrix Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M24]) ≥ 2.0 μg/mL | 237 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M24]) ≥ 2.0 μg/mL | 97 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M24]) ≥ 0.3 μg/mL | 105 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M24]) ≥ 0.3 μg/mL | 108 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSA (PI [M24]) ≥ 2.0 μg/mL | 103 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSY (PI [M24]) ≥ 0.3 μg/mL | 110 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M24]) ≥ 0.3 μg/mL | 111 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSW-135 (PI [M24]) ≥ 2.0 μg/mL | 93 Participants |
| Mencevax Group | Number of Subjects With Anti-PS Antibodies | Anti-PSC (PI [M24]) ≥ 2.0 μg/mL | 107 Participants |
Secondary
Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies
Cut-off values assessed were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time frame: Prior to and 1 Month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Anti-TT (PRE) | 223 Participants |
| Nimenrix Group | Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Anti-TT (PI [M1]) | 326 Participants |
| Mencevax Group | Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Anti-TT (PRE) | 110 Participants |
| Mencevax Group | Number of Subjects With Anti-Tetanus (Anti-TT) Antibodies | Anti-TT (PI [M1]) | 113 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = pain that prevented normal activity. Grade 3 Redness/Swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 143 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 7 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 57 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 1 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 42 Participants |
| Nimenrix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 1 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 4 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 40 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 1 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Mencevax Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 8 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available and who had the symptoms sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 1 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 13 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | ≥ 37.5 ˚C Fever | 16 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 2 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 55 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 6 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | >39.5 ˚C Fever | 0 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 65 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 35 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 10 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 41 Participants |
| Nimenrix Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 3 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 8 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 13 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 8 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | ≥ 37.5 ˚C Fever | 4 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | >39.5 ˚C Fever | 0 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 2 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal | 5 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal | 0 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal | 0 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 15 Participants |
| Mencevax Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
Secondary
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 up to 6 Months after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 1 Participants |
| Mencevax Group | Number of Subjects With New Onset of Chronic Illnesses (NOCIs) | 0 Participants |
Secondary
Number of Subjects With Rash
Time frame: From Day 0 up to 6 Months after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Rash | 0 Participants |
| Mencevax Group | Number of Subjects With Rash | 1 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 3
Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M36]) ≥ 1:8 | 322 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M36]) ≥ 1:128 | 319 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M36]) ≥ 1:8 | 334 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M36]) ≥ 1:128 | 313 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M36]) ≥ 1:8 | 335 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M36]) ≥ 1:128 | 332 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M36]) ≥ 1:8 | 337 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M36]) ≥ 1:128 | 336 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M36]) ≥ 1:128 | 105 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M36]) ≥ 1:8 | 104 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M36]) ≥ 1:8 | 91 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M36]) ≥ 1:128 | 98 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M36]) ≥ 1:8 | 107 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M36]) ≥ 1:8 | 108 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M36]) ≥ 1:128 | 84 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M36]) ≥ 1:128 | 102 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 4
Population: The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M48]) ≥ 1:8 | 270 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M48]) ≥ 1:128 | 245 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M48]) ≥ 1:8 | 276 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M48]) ≥ 1:128 | 254 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M48]) ≥ 1:8 | 231 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M48]) ≥ 1:128 | 214 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M48]) ≥ 1:8 | 256 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M48]) ≥ 1:128 | 243 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M48]) ≥ 1:128 | 37 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M48]) ≥ 1:8 | 79 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M48]) ≥ 1:8 | 27 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M48]) ≥ 1:128 | 66 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M48]) ≥ 1:8 | 47 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M48]) ≥ 1:8 | 90 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M48]) ≥ 1:128 | 22 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M48]) ≥ 1:128 | 79 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 5
Population: The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M60]) ≥ 1:8 | 43 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M60]) ≥ 1:128 | 39 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M60]) ≥ 1:8 | 37 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M60]) ≥ 1:128 | 28 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M60]) ≥ 1:8 | 44 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M60]) ≥ 1:128 | 38 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M60]) ≥ 1:8 | 47 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M60]) ≥ 1:128 | 47 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M60]) ≥ 1:128 | 11 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M60]) ≥ 1:8 | 11 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M60]) ≥ 1:8 | 6 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M60]) ≥ 1:128 | 3 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M60]) ≥ 1:8 | 12 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M60]) ≥ 1:8 | 7 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M60]) ≥ 1:128 | 6 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M60]) ≥ 1:128 | 5 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 2
Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M24]) ≥ 1:8 | 337 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M24]) ≥ 1:128 | 335 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M24]) ≥ 1:8 | 343 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M24]) ≥ 1:128 | 332 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M24]) ≥ 1:8 | 344 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M24]) ≥ 1:128 | 341 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M24]) ≥ 1:8 | 344 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M24]) ≥ 1:128 | 342 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M24]) ≥ 1:128 | 105 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M24]) ≥ 1:8 | 101 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M24]) ≥ 1:8 | 100 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M24]) ≥ 1:128 | 98 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M24]) ≥ 1:8 | 110 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M24]) ≥ 1:8 | 110 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M24]) ≥ 1:128 | 90 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M24]) ≥ 1:128 | 103 Participants |
Secondary
Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titres was greater than or equal to (≥) 1:8 and ≥ 1:128.
Time frame: At Year 1
Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M12]) ≥ 1:8 | 353 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M12]) ≥ 1:128 | 352 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M12]) ≥ 1:8 | 352 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M12]) ≥ 1:128 | 343 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M12]) ≥ 1:8 | 355 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M12]) ≥ 1:128 | 354 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M12]) ≥ 1:8 | 355 Participants |
| Nimenrix Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M12]) ≥ 1:128 | 354 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M12]) ≥ 1:128 | 114 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M12]) ≥ 1:8 | 113 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M12]) ≥ 1:8 | 117 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M12]) ≥ 1:128 | 112 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M12]) ≥ 1:8 | 116 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M12]) ≥ 1:8 | 114 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M12]) ≥ 1:128 | 111 Participants |
| Mencevax Group | Number of Subjects With rSBA Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M12]) ≥ 1:128 | 110 Participants |
Secondary
Number of Subjects With SAEs
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: At Year 1, Year 2, Year 3, Year 4 and Year 5
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With SAEs | Any (SAE)s Year 2 | 0 Participants |
| Nimenrix Group | Number of Subjects With SAEs | Any (SAE)s Year 4 | 0 Participants |
| Nimenrix Group | Number of Subjects With SAEs | Any (SAE)s Year 3 | 0 Participants |
| Nimenrix Group | Number of Subjects With SAEs | Any (SAE)s Year 5 | 0 Participants |
| Nimenrix Group | Number of Subjects With SAEs | Any (SAE)s Year 1 | 0 Participants |
| Mencevax Group | Number of Subjects With SAEs | Any (SAE)s Year 5 | 0 Participants |
| Mencevax Group | Number of Subjects With SAEs | Any (SAE)s Year 1 | 0 Participants |
| Mencevax Group | Number of Subjects With SAEs | Any (SAE)s Year 2 | 0 Participants |
| Mencevax Group | Number of Subjects With SAEs | Any (SAE)s Year 3 | 0 Participants |
| Mencevax Group | Number of Subjects With SAEs | Any (SAE)s Year 4 | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
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 Day 0 up to 6 Months after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Mencevax Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8 and (≥) 1:128.
Time frame: Prior to and 1 Month after vaccination
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects from whom immunogenicity data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) ≥ 1:8 | 290 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M1]) ≥ 1:8 | 323 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) ≥ 1:128 | 273 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M1]) ≥ 1:128 | 322 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) ≥ 1:8 | 253 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M1]) ≥ 1:8 | 340 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) ≥ 1:128 | 172 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M1]) ≥ 1:128 | 340 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) ≥ 1:8 | 247 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M1]) ≥ 1:8 | 339 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) ≥ 1:128 | 191 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M1]) ≥ 1:128 | 338 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) ≥ 1:8 | 306 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M1]) ≥ 1:8 | 340 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) ≥ 1:128 | 264 Participants |
| Nimenrix Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M1]) ≥ 1:128 | 339 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M1]) ≥ 1:128 | 114 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) ≥ 1:8 | 88 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) ≥ 1:8 | 89 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M1]) ≥ 1:8 | 112 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) ≥ 1:8 | 105 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PRE) ≥ 1:128 | 81 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M1]) ≥ 1:8 | 114 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenA (PI [M1]) ≥ 1:128 | 112 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PRE) ≥ 1:128 | 88 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) ≥ 1:8 | 96 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PRE) ≥ 1:128 | 67 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M1]) ≥ 1:8 | 114 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenY (PI [M1]) ≥ 1:8 | 114 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PRE) ≥ 1:128 | 56 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenW-135 (PI [M1]) ≥ 1:128 | 114 Participants |
| Mencevax Group | Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers ≥ the Cut-off Value | rSBA-MenC (PI [M1]) ≥ 1:128 | 112 Participants |
Secondary
Number of Subjects With Unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Up to 31 Days after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects from whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Unsolicited AEs | 18 Participants |
| Mencevax Group | Number of Subjects With Unsolicited AEs | 8 Participants |
Secondary
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 1
Population: The analysis was performed on the ATP cohort for persistence Year 1, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 1 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PI [M12]) | 2084.9 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PI [M12]) | 1848.6 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M12]) | 2993.5 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PI [M12]) | 4207.1 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PI [M12]) | 1386.5 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PI [M12]) | 1099.1 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M12]) | 699.9 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PI [M12]) | 1876.5 Titer |
Secondary
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: Prior to and 1 Month after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 330.7 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 93 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 84.1 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M1]) | 8576.5 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PI [M1]) | 4944.6 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 310 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PI [M1]) | 10073.7 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PI [M1]) | 10315.2 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PI [M1]) | 4573.7 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PRE) | 227.8 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PI [M1]) | 2190.1 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PRE) | 114.1 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PI [M1]) | 6545.6 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PRE) | 115.3 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M1]) | 2969.5 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PRE) | 282.8 Titer |
Secondary
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 5
Population: The analysis was performed on the ATP cohort for persistence Year 5, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 5 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M60]) | 281.6 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PI [M60]) | 189.8 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PI [M60]) | 78.5 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PI [M60]) | 769.7 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PI [M60]) | 74.1 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M60]) | 15.4 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PI [M60]) | 17.3 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PI [M60]) | 37 Titer |
Secondary
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 2
Population: The analysis was performed on the ATP cohort for persistence Year 2, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 2 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PI [M24]) | 1326.8 Titre |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PI [M24]) | 1162 Titre |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M24]) | 1984.6 Titre |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PI [M24]) | 3042.1 Titre |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PI [M24]) | 850.2 Titre |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PI [M24]) | 698.9 Titre |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M24]) | 319.1 Titre |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PI [M24]) | 1229.4 Titre |
Secondary
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 4
Population: The analysis was performed on the ATP cohort for persistence Year 4, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 4 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PI [M48]) | 278.6 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PI [M48]) | 273.6 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M48]) | 175.1 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PI [M48]) | 350.5 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PI [M48]) | 26 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PI [M48]) | 105.4 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M48]) | 11.3 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PI [M48]) | 315 Titer |
Secondary
rSBA Antibody Titers
Antibody titers are presented as Geometric Mean Titers (GMTs).
Time frame: At Year 3
Population: The analysis was performed on the ATP cohort for persistence Year 3, which included all evaluable subjects who received the vaccine during the vaccination phase, without a previous dose of meningococcal serogroup A, C, W-135, or Y vaccines and who had available results for at least one tested antigen at the Year 3 time-point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenA (PI [M36]) | 1238.4 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenC (PI [M36]) | 870.3 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M36]) | 2109.2 Titer |
| Nimenrix Group | rSBA Antibody Titers | rSBA-MenY (PI [M36]) | 2567.3 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenY (PI [M36]) | 848 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenA (PI [M36]) | 596.9 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenW-135 (PI [M36]) | 332.8 Titer |
| Mencevax Group | rSBA Antibody Titers | rSBA-MenC (PI [M36]) | 1124.8 Titer |