Infections, Meningococcal
Conditions
Keywords
Meningococcal vaccine, Booster vaccination, Immunogenicity, Meningococcal disease, Safety
Brief summary
In this study, the concentration of antibody to the vaccine one year, three and five years after vaccination in subjects who were vaccinated with GSK Biologicals' meningococcal vaccine GSK134612 and Menactra® in a previous study (whose objectives & outcome measures are presented in a separate protocol posting with NCT number =00454909) will be evaluated. The safety and immune response to a booster dose of vaccine GSK134612 administered at 5 years post-primary vaccination and a primary vaccination of a newly enrolled group with GSK 134612 vaccine will also be evaluated.
Detailed description
GSK Biologicals has developed a meningococcal conjugate vaccine (GSK134612). This candidate vaccine has been shown to be well tolerated and immunogenic in subjects as of 12 months of age. The purpose of this study is to evaluate the antibody persistence at approximately 1 year, 3 years and 5 years post-administration of one dose of GlaxoSmithKline (GSK) Biologicals' meningococcal vaccine GSK134612 as compared to Menactra® (meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine, sanofi pasteur) when given to healthy adolescents/ adults 11 to 25 years of age In addition, the safety and immunogenicity of a booster dose of GSK134612 administered to all eligible subjects at 5 years after the primary vaccination will be evaluated. Another cohort of subjects (naïve control group) 15 to \<31 years of age will be offered a dose of MenACWY-TT vaccine at the same time to allow for evaluation of a primary (naïve control group) and booster dose within the same study. This Protocol Posting has been updated following Protocol Amendment 1, May 2010 and Protocol Amendment 2, May 2011.
Interventions
BIOLOGICALNimenrix
One dose, as intramuscular injection
PROCEDUREBlood sampling
Blood samples will be collected from subjects 10-25 years of age as per enrollment in primary study and from subjects in the Nimerix Naive Group at Month 60 (Year 5) and 1 month post booster vaccination (Month 61).
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
Persistence phase: * A male or female who was between and including 10 and 25 years of age at the time of primary vaccination in the study with NCT number = 00454909. * Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. * Healthy subjects as established by medical history. * Having completed the active phase of the vaccination study with NCT number = 00454909. Booster phase: * Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. * Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * Healthy subjects as established by medical history and history-directed physical examination before entering into the study. * If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oophorectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination. Additional inclusion criterion for the naïve control group: • A male or female between, and including, 15 and 30 years of age at the time of the vaccination.
Exclusion criteria
Persistence phase: * Use of any investigational or non-registered product within 30 days of each persistence time point. * Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909. * History of any meningococcal disease due to serogroup A, B, C, W-135, or Y. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. * Administration of immunoglobulins and/or any blood products within the three months preceding each persistence time point. * Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. * Chronic alcohol or drug abuse. * Subjects withdrew consent to be contacted for follow-up studies. Booster phase (to be checked at Year 5 for all subject, including naïve control group): * Child in care * Not enrolled in the Kaiser Healthcare system. * Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior administration of the booster dose. * Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909. * History of any meningococcal disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition,including human immunodeficiency virus infection based on medical history and physical examination. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy. * History of chronic alcohol consumption and/or drug abuse. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine. * Previous vaccination with tetanus and diphtheria toxoids within the last month. * A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex. * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Previous history of Guillain-Barré syndrome * Acute disease at the time of vaccination. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination. * For groups A, B and C only: Subjects withdrew consent to be contacted for follow-up studies. Note: if the subject is female, prior to vaccination she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | At year 1 persistence | hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8. |
| Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | At year 3 persistence | hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | At year 1 persistence | The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL. |
| Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | At year 1 persistence | Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL. |
| Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication | From 6 months up to 1 year following primary 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 With SAEs Related to Study Participation or to a Concurrent GSK Medication | From 6 months up to 3 years following primary 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 With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | 1 month post primary (naïve control group) and booster vaccination | The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8. |
| Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | At year 1 persistence | hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4. |
| Number of Subjects With Solicited Local Symptoms | During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm). |
| Number of Subjects With Solicited General Symptoms | During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination | Unsolicited AE covers any AE 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 New Onset Chronic Illness(es) (NOCIs) | During the 6-month period following the primary (naïve control group) and booster vaccination | Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies. |
| Number of Subjects With SAEs | During the 6-month period following the primary (naïve control group) and booster 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 With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | 1 month post primary (naïve control group) and booster vaccination | Vaccine response was defined as: For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination. |
| hSBA Antibody Titers | At year 1 persistence | Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively. |
Countries
United States
Participant flow
Recruitment details
At Year 5, subjects in Nimenrix 1, Menactra and Nimenrix 2 groups received a booster dose of Nimenrix. During booster phase, subjects in Nimenrix 1 and Nimenrix 2 groups were pooled. An additional naïve control group 15 to \< 31 years of age was enrolled at Year 5.
Pre-assignment details
A total of 818 subjects were enrolled in the study. Year 1, 3 and 5 included only those subjects who came for the visits during these persistence years.
Participants by arm
| Arm | Count |
|---|---|
| Nimenrix 1 Group Subjects 11-25 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination | 433 |
| Menactra Group Subjects 11-25 years of age who were previously vaccinated with 1 dose of Menactra vaccine at the time of vaccination | 147 |
| Nimenrix 2 Group Subjects 10\<11 years of age who were previously vaccinated with 1 dose of Nimenrix vaccine at the time of vaccination | 68 |
| Nimenrix naïve Group Naïve control group of subjects 15 to \< 31 years at the time of primary vaccination with 1 dose of Nimenrix vaccine administered intramuscularly into the non-dominant deltoid in this current study during booster vaccination phase at Year 5. | 101 |
| Total | 749 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Booster and ESFU Phase | Lost to Follow-up | 0 | 0 | 0 | 6 | 1 | 13 |
| Booster and ESFU Phase | Other | 0 | 0 | 0 | 5 | 1 | 0 |
Baseline characteristics
| Characteristic | Nimenrix 2 Group | Nimenrix 1 Group | Menactra Group | Nimenrix naïve Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 11.2 Years STANDARD_DEVIATION 0.42 | 15.9 Years STANDARD_DEVIATION 2.79 | 16.0 Years STANDARD_DEVIATION 2.83 | 23.3 Years STANDARD_DEVIATION 4.74 | 16.5 Years STANDARD_DEVIATION 4.26 |
| Sex: Female, Male Female | 41 Participants | 213 Participants | 78 Participants | 65 Participants | 397 Participants |
| Sex: Female, Male Male | 27 Participants | 220 Participants | 69 Participants | 36 Participants | 352 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 100 / 183 | 20 / 38 | 55 / 101 |
| serious Total, serious adverse events | 0 / 433 | 0 / 147 | 0 / 68 | 3 / 183 | 0 / 38 | 0 / 101 |
Outcome results
Primary
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Time frame: At year 3 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=314;78;51] | 117 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=317;80;53] | 295 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=321;79;53] | 306 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=319;79;51] | 306 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=319;79;51] | 70 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=314;78;51] | 37 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=321;79;53] | 67 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=317;80;53] | 65 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=319;79;51] | 49 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=317;80;53] | 51 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=321;79;53] | 51 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=314;78;51] | 22 Subjects |
Primary
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Time frame: At year 5 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=141;45;24] | 69 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=140;44;26] | 130 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=138;44;26] | 120 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=142;44;26] | 134 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=142;44;26] | 40 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=141;45;24] | 20 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=138;44;26] | 37 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=140;44;26] | 35 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=142;44;26] | 24 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=140;44;26] | 22 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=138;44;26] | 24 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=141;45;24] | 9 Subjects |
Primary
Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:8.
Time frame: At year 1 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=350;111;57] | 102 Subjects |
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=336;105;56] | 319 Subjects |
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=327;107;54] | 322 Subjects |
| Nimenrix 1 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=356;112;58] | 348 Subjects |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=356;112;58] | 97 Subjects |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=350;111;57] | 35 Subjects |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=327;107;54] | 81 Subjects |
| Menactra Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=336;105;56] | 77 Subjects |
| Nimenrix 2 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=356;112;58] | 58 Subjects |
| Nimenrix 2 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=336;105;56] | 55 Subjects |
| Nimenrix 2 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=327;107;54] | 53 Subjects |
| Nimenrix 2 Group | Number of Subjects With Serum Bactericidal Assay (Using Human Complement) (hSBA) Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=350;111;57] | 15 Subjects |
Secondary
Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations
Antibody concentrations were given as geometric mean concentrations (GMCs) and expressed in μg/mL.
Time frame: At year 1 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSA [N=355;112;56] | 5.0 μg/mL |
| Nimenrix 1 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSC [N=366;112;58] | 1.8 μg/mL |
| Nimenrix 1 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSW-135 [N=354;104;56] | 2.0 μg/mL |
| Nimenrix 1 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSY [N=358;112;59] | 3.4 μg/mL |
| Menactra Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSY [N=358;112;59] | 1.0 μg/mL |
| Menactra Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSA [N=355;112;56] | 3.7 μg/mL |
| Menactra Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSW-135 [N=354;104;56] | 0.8 μg/mL |
| Menactra Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSC [N=366;112;58] | 0.6 μg/mL |
| Nimenrix 2 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSY [N=358;112;59] | 2.5 μg/mL |
| Nimenrix 2 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSC [N=366;112;58] | 2.1 μg/mL |
| Nimenrix 2 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSW-135 [N=354;104;56] | 2.0 μg/mL |
| Nimenrix 2 Group | Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Antibody Concentrations | Anti-PSA [N=355;112;56] | 4.2 μg/mL |
Secondary
hSBA Antibody Titers
Titers are given as GMTs for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time frame: 1 month post primary (naïve control group) and booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenA Titers [N=106;28;79] | 783.8 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenC Titers [N=109;29;81] | 5020.4 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenW-135 Titers [N=109;29;80] | 5517.6 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenY Titers [N=109;29;84] | 5664.3 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenY Titers [N=109;29;84] | 6546.4 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenA Titers [N=106;28;79] | 952.0 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenW-135 Titers [N=109;29;80] | 3729.0 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenC Titers [N=109;29;81] | 6722.1 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenY Titers [N=109;29;84] | 755.1 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenC Titers [N=109;29;81] | 534.7 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenW-135 Titers [N=109;29;80] | 237.7 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenA Titers [N=106;28;79] | 79.7 Titers |
Secondary
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time frame: At year 1 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenA titers [N=350;111;57] | 5.4 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenC titers [N=336;105;56] | 172.0 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=327;107;54] | 197.5 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenY titers [N=356;112;58] | 271.8 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenY titers [N=356;112;58] | 100.8 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenA titers [N=350;111;57] | 6.0 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=327;107;54] | 48.9 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenC titers [N=336;105;56] | 46.7 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenY titers [N=356;112;58] | 266.8 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenC titers [N=336;105;56] | 238.3 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=327;107;54] | 231.2 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenA titers [N=350;111;57] | 5.2 Titers |
Secondary
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time frame: At year 3 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenA titers [N=314;78;51] | 6.2 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenC titers [N=317;80;53] | 117.9 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=321;79;53] | 141.6 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenY titers [N=319;79;51] | 206.6 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenY titers [N=319;79;51] | 139.0 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenA titers [N=314;78;51] | 9.3 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=321;79;53] | 75.5 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenC titers [N=317;80;53] | 54.8 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenY titers [N=319;79;51] | 186.6 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenC titers [N=317;80;53] | 131.2 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=321;79;53] | 137.6 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenA titers [N=314;78;51] | 8.8 Titers |
Secondary
hSBA Antibody Titers
Titers are given as geometric mean titers (GMTs) for the serogroups hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY respectively.
Time frame: At year 5 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenA titers [N=141;45;24] | 8.9 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenC titers [N=140;44;26] | 94.6 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=138;44;26] | 103.5 Titers |
| Nimenrix 1 Group | hSBA Antibody Titers | hSBA-MenY titers [N=142;44;26] | 224.6 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenY titers [N=142;44;26] | 129.3 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenA titers [N=141;45;24] | 7.9 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=138;44;26] | 70.4 Titers |
| Menactra Group | hSBA Antibody Titers | hSBA-MenC titers [N=140;44;26] | 30.6 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenY titers [N=142;44;26] | 113.7 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenC titers [N=140;44;26] | 92.9 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenW-135 titers [N=138;44;26] | 92.4 Titers |
| Nimenrix 2 Group | hSBA Antibody Titers | hSBA-MenA titers [N=141;45;24] | 6.3 Titers |
Secondary
Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs)
Examples of NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Time frame: During the 6-month period following the primary (naïve control group) and booster vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs) | 0 Subjects |
| Menactra Group | Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs) | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects Reporting New Onset Chronic Illness(es) (NOCIs) | 0 Subjects |
Secondary
Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values
The cut-off values were defined as a concentration ≥0.3 microgram per milliliter (μg/mL) and ≥2.0 μg/mL.
Time frame: At year 1 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [N=355;112;56] | 340 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [N=355;112;56] | 260 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [N=366;112;58] | 302 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [N=366;112;58] | 162 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [N=354;104;56] | 319 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [N=354;104;56] | 178 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [N=358;112;59] | 342 Subjects |
| Nimenrix 1 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [N=358;112;59] | 240 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [N=366;112;58] | 56 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [N=358;112;59] | 78 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [N=366;112;58] | 31 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [N=354;104;56] | 65 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [N=354;104;56] | 27 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [N=355;112;56] | 101 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [N=355;112;56] | 66 Subjects |
| Menactra Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [N=358;112;59] | 38 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSC ≥ 0.3 µg/mL [N=366;112;58] | 51 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSA ≥ 2.0 µg/mL [N=355;112;56] | 38 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSA ≥ 0.3 µg/mL [N=355;112;56] | 55 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSC ≥ 2.0 µg/mL [N=366;112;58] | 28 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSY ≥ 0.3 µg/mL [N=358;112;59] | 55 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSW-135 ≥ 2.0 µg/mL [N=354;104;56] | 28 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSW-135 ≥ 0.3 µg/mL [N=354;104;56] | 54 Subjects |
| Nimenrix 2 Group | Number of Subjects With Anti-polysaccharide A (Anti-PSA), Anti-PSC, Anti-PSY, and Anti-PSW-135 Concentrations Equal to or Above the Cut-off Values | Anti-PSY ≥ 2.0 µg/mL [N=358;112;59] | 37 Subjects |
Secondary
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values
The cut-off values were defined as hSBA antibody titers ≥ 1:4 and ≥ 1:8.
Time frame: 1 month post primary (naïve control group) and booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenA ≥ 1:4 [N=106;28;79] | 105 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenA ≥ 1:8 [N=106;28;79] | 105 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC ≥ 1:4 [N=109;29;81] | 108 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC ≥ 1:8 [N=109;29;81] | 108 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 ≥ 1:4 [N=109;29;80] | 109 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 ≥ 1:8 [N=109;29;80] | 109 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY ≥ 1:4 [N=109;29;84] | 109 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY ≥ 1:8 [N=109;29;84] | 109 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC ≥ 1:4 [N=109;29;81] | 29 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY ≥ 1:4 [N=109;29;84] | 29 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC ≥ 1:8 [N=109;29;81] | 29 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 ≥ 1:4 [N=109;29;80] | 29 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 ≥ 1:8 [N=109;29;80] | 29 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenA ≥ 1:4 [N=106;28;79] | 28 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenA ≥ 1:8 [N=106;28;79] | 28 Subjects |
| Menactra Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY ≥ 1:8 [N=109;29;84] | 29 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC ≥ 1:4 [N=109;29;81] | 78 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenA ≥ 1:8 [N=106;28;79] | 61 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenA ≥ 1:4 [N=106;28;79] | 61 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenC ≥ 1:8 [N=109;29;81] | 77 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY ≥ 1:4 [N=109;29;84] | 82 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 ≥ 1:8 [N=109;29;80] | 74 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 ≥ 1:4 [N=109;29;80] | 74 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Equal to or Above the Cut-off Values | hSBA-MenY ≥ 1:8 [N=109;29;84] | 82 Subjects |
Secondary
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Time frame: At year 3 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 3, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=314;78;51] | 123 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=317;80;53] | 295 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=321;79;53] | 307 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=319;79;51] | 306 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=319;79;51] | 70 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=314;78;51] | 37 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=321;79;53] | 67 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=317;80;53] | 68 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=319;79;51] | 49 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=317;80;53] | 51 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=321;79;53] | 52 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=314;78;51] | 23 Subjects |
Secondary
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Time frame: At year 5 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 5, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=141;45;24] | 74 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=140;44;26] | 134 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=138;44;26] | 122 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=142;44;26] | 134 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=142;44;26] | 40 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=141;45;24] | 20 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=138;44;26] | 37 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=140;44;26] | 39 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=142;44;26] | 24 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=140;44;26] | 24 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=138;44;26] | 24 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=141;45;24] | 9 Subjects |
Secondary
Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values
hSBA antibody titers were assessed for the hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-MenY serogroups respectively. The antibody cut-off value assessed was equal to or above 1:4.
Time frame: At year 1 persistence
Population: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of persistence for Year 1, on all eligible subjects who had received primary vaccination during the primary study and who had available assay results for at least one tested antigen at the considered time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=350;111;57] | 106 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=336;105;56] | 319 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=327;107;54] | 322 Subjects |
| Nimenrix 1 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=356;112;58] | 348 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=356;112;58] | 97 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=350;111;57] | 35 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=327;107;54] | 81 Subjects |
| Menactra Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=336;105;56] | 77 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenY [N=356;112;58] | 58 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenC [N=336;105;56] | 55 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenW-135 [N=327;107;54] | 54 Subjects |
| Nimenrix 2 Group | Number of Subjects With hSBA Titers Equal to or Above the Cut-off Values | hSBA-MenA [N=350;111;57] | 17 Subjects |
Secondary
Number of Subjects With 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: During the 6-month period following the primary (naïve control group) and booster vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects With SAEs | 3 Subjects |
| Menactra Group | Number of Subjects With SAEs | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With SAEs | 0 Subjects |
Secondary
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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 6 months up to 5 years following primary vaccination
Population: Analysis was performed on Total cohort at Year 5 which included all subjects vaccinated in the primary study and who came back to the visit at Year 5.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication | 0 Subjects |
| Menactra Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication | 0 Subjects |
Secondary
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication
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 6 months up to 3 years following primary vaccination
Population: Analysis was performed on Total cohort at Year 3 which included all subjects vaccinated in the primary study and who came back to the visit at Year 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication | 0 Subjects |
| Menactra Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication | 0 Subjects |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication
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 6 months up to 1 year following primary vaccination
Population: Analysis was performed on Total cohort at Year 1 which included all subjects vaccinated in the primary study and who came back to the visit at Year 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication | 0 Subjects |
| Menactra Group | Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With Serious Adverse Events (SAEs) Related to a Concurrent GSK Medication | 0 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and temperature. Any = occurrence of any general symptoms reported irrespective of intensity grade and relationship to study vaccination. Any temperature = axillary temperature greater than or equal to (≥)37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Time frame: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 3 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Related Headache | 60 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 58 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Any Headache | 61 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms | 28 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 57 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 2 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 4 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms | 28 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms | 8 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 7 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 6 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms | 8 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Any Headache | 10 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Related Headache | 10 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Any Gastrointestinal symptoms | 20 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Temperature | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Related Headache | 21 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Related Fatigue | 29 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Any Fatigue | 30 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Any Temperature | 3 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Fatigue | 1 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Related Gastrointestinal symptoms | 17 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 2 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Related Temperature | 2 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Any Headache | 22 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited General Symptoms | Grade 3 Headache | 1 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeter (mm).
Time frame: During the 4-day (Days 0-3) post primary (naïve control group) and booster vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 2 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 39 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 100 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 27 Subjects |
| Nimenrix 1 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 6 Subjects |
| Menactra Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 6 Subjects |
| Menactra Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 1 Subjects |
| Menactra Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 20 Subjects |
| Menactra Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Subjects |
| Menactra Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 5 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 14 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 55 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 2 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 17 Subjects |
| Nimenrix 2 Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 1 Subjects |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE 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: During the 31-day (Days 0-30) following primary (naïve control group) and booster vaccination
Population: Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects in the primary study with a booster vaccine administration documented, newly enrolled group administered primary vaccination at Year 5 and also had symptom sheet completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 40 Subjects |
| Menactra Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 9 Subjects |
| Nimenrix 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 16 Subjects |
Secondary
Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Vaccine response was defined as: For initially seronegative subjects: antibody titre ≥ 1:8 at one month after vaccination For initially seropositive subjects: antibody titre at one month after vaccination ≥ 4 fold the titres before vaccination.
Time frame: 1 month post primary (naïve control group) and booster vaccination
Population: Analysis was performed on the ATP cohort for immunogenicity at Month 61 which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the primary (naïve control group) or booster vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nimenrix 1 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 [N=105;28;76] | 101 Subjects |
| Nimenrix 1 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA [N=101;28;75] | 98 Subjects |
| Nimenrix 1 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY [N=106;29;78] | 97 Subjects |
| Nimenrix 1 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC [N=106;28;68] | 97 Subjects |
| Menactra Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 [N=105;28;76] | 24 Subjects |
| Menactra Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC [N=106;28;68] | 27 Subjects |
| Menactra Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA [N=101;28;75] | 24 Subjects |
| Menactra Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY [N=106;29;78] | 27 Subjects |
| Nimenrix 2 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenC [N=106;28;68] | 47 Subjects |
| Nimenrix 2 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenA [N=101;28;75] | 51 Subjects |
| Nimenrix 2 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenY [N=106;29;78] | 53 Subjects |
| Nimenrix 2 Group | Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies | hSBA-MenW-135 [N=105;28;76] | 51 Subjects |