Infections, Meningococcal, Meningococcal Vaccines
Conditions
Keywords
safety, meningococcal vaccine, immunogenicity
Brief summary
The purpose of this study is to demonstrate, in 2-10 year old subjects, the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
Multicentre study with 2 treatment groups. Two blood samples will be taken, prior to and one month after vaccination, from the first 75% enrolled subjects per country independent of the treatment group.
Interventions
BIOLOGICALNimenrix
Single dose, intramuscular injection
BIOLOGICALMencevax
Single dose, subcutaneous injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents or guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 2 and 10 years of age at the time of vaccination. * Written informed consent obtained from the parent or guardian 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 parents'/guardians' knowledge.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine. * Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above). * Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y. * Previous vaccination with tetanus toxoid within the last month. * History of meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.. * History of reactions or allergic disease likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | One month after vaccination (Post-vaccination, study Month 1) | Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8). |
| Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | During the 4-day (Days 0-3) post-vaccination period | Grade 3 symptom was defined as symptom that prevented normal, everyday activities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Pre vaccination (Month 0) and post vaccination (Month 1) | The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively. |
| Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Pre vaccination (Month 0) and post vaccination (Month 1) | Antibody concentrations were expressed as geometric mean concentrations (GMCs) |
| Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Pre vaccination (Month 0) and post vaccination, (Month 1) | The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. |
| Anti-polysaccharide (Anti-PS) Antibody Concentrations | Pre vaccination (Month 0) and post vaccination (Month 1) | Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY. |
| Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. |
| Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | Pre vaccination (Month 0) and post vaccination (Month 1) | The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively. |
| Number of Subjects < 6 Years of Age With Solicited General Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. |
| Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination. |
| Number of Subjects Reporting Specific Adverse Events (AEs) | From Day 0 up to 6 months after vaccination | Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office visits. |
| Number of Subjects Reporting Any Unsolicited Symptoms | Up to one month (Day 0-Day 30) after vaccination | Unsolicited symptom covers any symptom 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. |
| Number of Subjects Reporting Any 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, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject. |
| Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | During the 4-day (Days 0-3) follow-up period after vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade. |
| rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | Pre vaccination (Month 0) and post vaccination (Month 1) | Antibody titers were expressed as geometric mean titers (GMTs). |
Countries
India, Lebanon, Philippines, Saudi Arabia
Participant flow
Pre-assignment details
A total of 1504 subjects were enrolled into the study, and 1501 of them were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix Group Subjects received 1 dose of Nimenrix vaccine at Month 0. Nimenrix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm. | 1,125 |
| Mencevax ACWY Group Subjects received 1 dose of Mencevax ACWY vaccine at Month 0. Mencevax ACWY vaccine was administered subcutaneously into the upper region of the non-dominant arm. | 376 |
| Total | 1,501 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 21 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Mencevax ACWY Group | Total | Nimenrix Group |
|---|---|---|---|
| Age, Continuous | 5.5 Years STANDARD_DEVIATION 2.45 | 5.57 Years STANDARD_DEVIATION 2.48 | 5.6 Years STANDARD_DEVIATION 2.49 |
| Race/Ethnicity, Customized Asian - Central/ South Asian heritage, n(%) | 101 Participants | 401 Participants | 300 Participants |
| Race/Ethnicity, Customized Asian - Japanese heritage, n(%) | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian heritage, n(%) | 199 Participants | 796 Participants | 597 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander, n(%) | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White - Arabic/ North African heritage, n(%) | 74 Participants | 295 Participants | 221 Participants |
| Race/Ethnicity, Customized White - Caucasian/ European heritage, n(%) | 1 Participants | 5 Participants | 4 Participants |
| Sex/Gender, Customized Female | 175 Participants | 701 Participants | 526 Participants |
| Sex/Gender, Customized Male | 201 Participants | 800 Participants | 599 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,125 | 0 / 376 |
| other Total, other adverse events | 416 / 1,125 | 155 / 376 |
| serious Total, serious adverse events | 15 / 1,125 | 7 / 376 |
Outcome results
Primary
Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited)
Grade 3 symptom was defined as symptom that prevented normal, everyday activities.
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | 10 Participants |
| Mencevax ACWY Group | Number of Subjects With Grade 3 General Symptoms (Solicited and Unsolicited) | 1 Participants |
p-value: 0.220295% CI: [0.56, 20.25]Chi-squared
Primary
Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135
Vaccine response was defined as an rSBA titer of at least 1:32 in subjects initially seronegative (\< 1:8) and as 4-fold increase in titer from pre- to post-vaccination in subjects initially seropositive (≥ 1:8).
Time frame: One month after vaccination (Post-vaccination, study Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenA | 529 Participants |
| Nimenrix Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenC | 664 Participants |
| Nimenrix Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenW-135 | 673 Participants |
| Nimenrix Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenY | 670 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenY | 165 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenA | 124 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenW-135 | 195 Participants |
| Mencevax ACWY Group | Number of Subjects With Vaccine Response to N. Meningitidis Serogroups A (MenA), MenC, MenY and MenW-135 | rSBA-MenC | 210 Participants |
95% CI: [10.26, 20.23]
95% CI: [17.52, 31.87]
95% CI: [2.68, 11.08]Difference in percentage
95% CI: [18.02, 30.3]
Secondary
Anti-polysaccharide (Anti-PS) Antibody Concentrations
Anti-PS concentrations were expressed as geometric mean concentrations (GMCs) and expressed in μg/mL. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M0 | 0.4 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M1 | 81.1 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M0 | 0.18 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M1 | 22.61 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M0 | 0.17 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M1 | 12.8 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M0 | 0.18 μg/mL |
| Nimenrix Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M1 | 19.26 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M1 | 22.71 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M0 | 0.29 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M0 | 0.17 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSA, M1 | 25.43 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSY, M0 | 0.2 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M0 | 0.17 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSW-135, M1 | 13.85 μg/mL |
| Mencevax ACWY Group | Anti-polysaccharide (Anti-PS) Antibody Concentrations | Anti-PSC, M1 | 25.69 μg/mL |
Secondary
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Antibody concentrations were expressed as geometric mean concentrations (GMCs)
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Anti-TT, M0 | 0.65 Titer |
| Nimenrix Group | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Anti-TT, M1 | 21.731 Titer |
| Mencevax ACWY Group | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Anti-TT, M0 | 0.744 Titer |
| Mencevax ACWY Group | Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations | Anti-TT, M1 | 0.709 Titer |
Secondary
Number of Subjects < 6 Years of Age With Solicited General Symptoms
Solicited general symptoms assessed were drowsiness, fever (measured orally and temperature ≥ 37.5°C ), irritability and loss of appetite. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Any Drowsiness | 34 Participants |
| Nimenrix Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Fever ≥ 37.5°C | 50 Participants |
| Nimenrix Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Any Irritability | 31 Participants |
| Nimenrix Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Any Loss of apptite | 35 Participants |
| Mencevax ACWY Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Any Loss of apptite | 6 Participants |
| Mencevax ACWY Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Any Drowsiness | 5 Participants |
| Mencevax ACWY Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Any Irritability | 6 Participants |
| Mencevax ACWY Group | Number of Subjects < 6 Years of Age With Solicited General Symptoms | Fever ≥ 37.5°C | 12 Participants |
Secondary
Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms
Solicited general symptoms assessed were fatigue, fever (measured orally and temperature ≥ 37.5°C ), gastrointestinal and headache. Any was defined as incidence of any general symptom regardless of intensity grade or relationship to vaccination.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Any Fatigue | 33 Participants |
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Fever ≥ 37.5°C | 48 Participants |
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Any Gastrointestinal | 25 Participants |
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Any Headache | 51 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Any Headache | 19 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Any Fatigue | 19 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Any Gastrointestinal | 15 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited General Symptoms | Fever ≥ 37.5°C | 19 Participants |
Secondary
Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Any Pain | 105 Participants |
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Any Redness | 107 Participants |
| Nimenrix Group | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Any Swelling | 54 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Any Redness | 36 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Any Pain | 50 Participants |
| Mencevax ACWY Group | Number of Subjects ≥ 6 Years of Age With Solicited Local Symptoms | Any Swelling | 16 Participants |
Secondary
Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any local symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) follow-up period after vaccination
Population: The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects for whom data were available and with the symptom sheet filled-in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Any Pain | 104 Participants |
| Nimenrix Group | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Any Redness | 82 Participants |
| Nimenrix Group | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Any Swelling | 31 Participants |
| Mencevax ACWY Group | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Any Pain | 39 Participants |
| Mencevax ACWY Group | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Any Redness | 31 Participants |
| Mencevax ACWY Group | Number of Subjects Less Than (<) 6 Years of Age With Solicited Local Symptoms | Any Swelling | 15 Participants |
Secondary
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability /incapacity or are a congenital anomaly/ birth defect in the offspring of a study subject.
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 for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 15 Participants |
| Mencevax ACWY Group | Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 7 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Symptoms
Unsolicited symptom covers any symptom 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.
Time frame: Up to one month (Day 0-Day 30) after vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nimenrix Group | Number of Subjects Reporting Any Unsolicited Symptoms | 198 Participants |
| Mencevax ACWY Group | Number of Subjects Reporting Any Unsolicited Symptoms | 75 Participants |
Secondary
Number of Subjects Reporting Specific Adverse Events (AEs)
Specific AEs include: rash; new onset of chronic illness(es) (NOCI) and/ or conditions prompting emergency room (ER) visits or non-routine physician office 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 for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects Reporting Specific Adverse Events (AEs) | Rash (es) | 45 Participants |
| Nimenrix Group | Number of Subjects Reporting Specific Adverse Events (AEs) | NOCI (s) | 3 Participants |
| Nimenrix Group | Number of Subjects Reporting Specific Adverse Events (AEs) | ER visit (s) | 15 Participants |
| Mencevax ACWY Group | Number of Subjects Reporting Specific Adverse Events (AEs) | Rash (es) | 16 Participants |
| Mencevax ACWY Group | Number of Subjects Reporting Specific Adverse Events (AEs) | NOCI (s) | 1 Participants |
| Mencevax ACWY Group | Number of Subjects Reporting Specific Adverse Events (AEs) | ER visit (s) | 4 Participants |
Secondary
Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values
The cut-off values for anti-PS concentrations were ≥ 0.3 microgram per milliliter (μg/mL) and ≥ 2.0 μg/mL respectively for the anti- PSA, anti-PSC, anti-PSW-135 and anti-PSY antibodies respectively. One half of the subjects (50%, randomized) of the ATP cohort for immunogenicity was tested for anti-PSA and anti-PSC and the other half for anti-PSW-135 and anti-PSY.
Time frame: Pre vaccination (Month 0) and post vaccination, (Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 0.3 μg/mL, M0 | 154 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 0.3 μg/mL, M1 | 369 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 2.0 μg/mL, M0 | 59 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 2.0 μg/mL, M1 | 368 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M0 | 29 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M1 | 365 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 2.0 μg/mL, M0 | 12 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 2.0 μg/mL M1 | 363 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 0.3 μg/mL, M0 | 18 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 0.3 μg/mL, M1 | 368 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 2.0 μg/mL M0 | 5 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 2.0 μg/mL M1 | 353 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 0.3 μg/mL, M0 | 28 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 0.3 μg/mL, M1 | 369 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 2.0 μg/mL, M0 | 11 Participants |
| Nimenrix Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 2.0 μg/mL, M1 | 362 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 2.0 μg/mL, M1 | 118 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 0.3 μg/mL, M0 | 41 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 0.3 μg/mL, M0 | 11 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 0.3 μg/mL, M1 | 126 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 0.3 μg/mL, M0 | 16 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 2.0 μg/mL, M0 | 12 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 0.3 μg/mL, M1 | 121 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSA ≥ 2.0 μg/mL, M1 | 123 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 2.0 μg/mL, M0 | 4 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M0 | 7 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 2.0 μg/mL M0 | 2 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 0.3 μg/mL, M1 | 127 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSY ≥ 0.3 μg/mL, M1 | 122 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 2.0 μg/mL, M0 | 2 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSW-135 ≥ 2.0 μg/mL M1 | 112 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-polysaccharide (Anti-PS) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-PSC ≥ 2.0 μg/mL M1 | 125 Participants |
Secondary
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values
The cut-off values for anti-TT concentrations were ≥ 0.1 international units per milliliter (IU/mL) and ≥ 1.0 IU/mL respectively.
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥ 0.1 IU/mL, M0 | 635 Participants |
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥ 0.1 IU/mL, M1 | 733 Participants |
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥ 1.0 IU/mL, M0 | 296 Participants |
| Nimenrix Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥1.0 IU/mL, M1 | 720 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥1.0 IU/mL, M1 | 107 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥ 0.1 IU/mL, M0 | 220 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥ 1.0 IU/mL, M0 | 107 Participants |
| Mencevax ACWY Group | Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Concentrations Greater Than or Equal to (≥) the Cut-off Values | Anti-TT ≥ 0.1 IU/mL, M1 | 218 Participants |
Secondary
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values
The cut-off values for the rSBA titers were ≥ 1:8 and ≥ 1:128 respectively.
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA ≥ 1:8, M0 | 491 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA≥ 1:8, M1 | 739 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA ≥ 1:128, M0 | 476 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA≥ 1:128, M1 | 739 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC≥ 1:8, M0 | 224 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC≥ 1:8, M1 | 738 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC ≥ 1:128 M0 | 157 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC ≥ 1:128 M1 | 736 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135 ≥ 1:8, M0 | 455 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135 ≥ 1:8, M1 | 742 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135. ≥ 1:128 M0 | 389 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135 ≥ 1:128 M1 | 742 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY ≥ 1:8, M0 | 630 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY ≥ 1:8, M1 | 742 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY≥ 1:128 M0 | 590 Participants |
| Nimenrix Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY ≥ 1:128 M1 | 742 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY ≥ 1:128 M1 | 246 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA ≥ 1:8, M0 | 162 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135 ≥ 1:8, M0 | 152 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA≥ 1:8, M1 | 246 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY ≥ 1:8, M0 | 198 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA ≥ 1:128, M0 | 155 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135 ≥ 1:8, M1 | 245 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenA≥ 1:128, M1 | 246 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY≥ 1:128 M0 | 188 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC≥ 1:8, M0 | 77 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135. ≥ 1:128 M0 | 133 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC≥ 1:8, M1 | 241 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenY ≥ 1:8, M1 | 248 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC ≥ 1:128 M0 | 51 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenW-135 ≥ 1:128 M1 | 245 Participants |
| Mencevax ACWY Group | Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Titers Greater Than or Equal (≥) to the Cut-off Values | rSBA-MenC ≥ 1:128 M1 | 234 Participants |
Secondary
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were expressed as geometric mean titers (GMTs).
Time frame: Pre vaccination (Month 0) and post vaccination (Month 1)
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 and for whom assay results were available for antibodies against at least one study vaccine antigen component from the blood sample taken one month after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, M0 | 80.1 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, M0 | 219.1 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, M1 | 11543.2 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, M0 | 14.5 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, M0 | 310 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, M1 | 6343.3 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, M1 | 10825.1 Titer |
| Nimenrix Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, M1 | 4813.1 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, M1 | 2613.1 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, M0 | 227.7 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenA, M1 | 2283.2 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, M0 | 14.2 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, M0 | 68.8 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenW-135, M1 | 2157.8 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenY, M0 | 241.7 Titer |
| Mencevax ACWY Group | rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers | rSBA-MenC, M1 | 1317 Titer |