Meningococcal Disease, Meningococcal Meningitis
Conditions
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence
Brief summary
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Detailed description
Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
Interventions
BIOLOGICALNovartis Meningococcal (MenACWY-CRM) vaccine
All subjects will have blood draws at Day 1, Day 8, and Day 29.
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 23 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adolescents or adults (age 16-23 years inclusive), either previously enrolled in the parent study or naïve to meningococcal vaccination. * Female subjects were to be negative for pregnancy
Exclusion criteria
* History of meningococcal disease * Receipt of any meningococcal vaccine outside of parent study (V59P6) * Serious, acute, or chronic illnesses including HIV infection/disease and any malignancy * receipt of any vaccine 14 days prior to the study, or expected through the duration of the study * any condition which in the eyes of the investigator would pose a health risk to the subject or render them inappropriate for a research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Day 1 (5 years after primary vaccination) | Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y |
| Geometric Mean Titer After Booster Vaccination | Day 8, Day 29 (5 years after primary vaccination) | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7, Day 28 post booster (5 years after primary vaccination) | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. |
| Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7, Day 28 post booster (5 years after primary vaccination) | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. |
| Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Day 1 (5 years after primary vaccination ) | Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y |
| Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Day 8, Day 29 (5 years after primary vaccination) | For a subject with hSBA titer \<4 at baseline, seroresponse is defined as a postvaccination hSBA titer \>=8; and for a subject with hSBA titer \>=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. |
| Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Up to Day 7 | Local and systemic reactions were solicited to assess safety and tolerability of vaccination |
| Geometric Mean Ratio After Booster Vaccination | Day 8 and Day 29 (at 5 Years After Primary Vaccination) | Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1 |
| Geometric Mean Titer at 5 Years After Primary Vaccination | Day 1 (5 years after primary vaccination ) | Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at 3 centers in the USA
Pre-assignment details
All subjects enrolled were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| I: MenACWY-CRM Vaccine Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago | 50 |
| II: Licensed Polysaccharide Meningococcal Vaccine Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago | 51 |
| III: Meningococcal Naive Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive | 54 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Inappropriate Enrollment | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 3 |
| Overall Study | Protocol Violation | 1 | 1 | 0 |
| Overall Study | Unable to Classify | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | I: MenACWY-CRM Vaccine | II: Licensed Polysaccharide Meningococcal Vaccine | III: Meningococcal Naive | Total |
|---|---|---|---|---|
| Age, Continuous | 18.8 years STANDARD_DEVIATION 1.9 | 19.2 years STANDARD_DEVIATION 2 | 20.5 years STANDARD_DEVIATION 2.3 | 19.5 years STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 22 Participants | 28 Participants | 33 Participants | 83 Participants |
| Sex: Female, Male Male | 28 Participants | 23 Participants | 21 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 38 / 50 | 36 / 50 | 46 / 53 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 53 |
Outcome results
Primary
Geometric Mean Titer After Booster Vaccination
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Time frame: Day 8, Day 29 (5 years after primary vaccination)
Population: Full analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Baseline, Men A | 5.16 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 8, Men A, | 1059 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 29, Men A, (N=48, G I) | 819 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Baseline, Men C | 20 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 8, Men C | 1603 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 29, Men C | 1217 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Baseline, Men W-135 | 29 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 8, Men W-135 | 1685 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 29, Men W-135 | 1644 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Baseline, Men Y | 28 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 8, Men Y, (N=48, GI) | 2561 Titer |
| I:MenACWY | Geometric Mean Titer After Booster Vaccination | Day 29, Men Y | 2092 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 29, Men Y | 63 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Baseline, Men A | 7.31 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Baseline, Men W-135 | 12 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 29, Men W-135 | 47 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 8, Men A, | 45 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 29, Men C | 51 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 8, Men Y, (N=48, GI) | 21 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 29, Men A, (N=48, G I) | 147 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 8, Men W-135 | 34 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Day 8, Men C | 36 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Baseline, Men C | 19 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer After Booster Vaccination | Baseline, Men Y | 7.8 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Baseline, Men C | 7.34 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 8, Men C | 70 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Baseline, Men Y | 8.69 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 29, Men C | 127 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Baseline, Men W-135 | 11 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 8, Men W-135 | 63 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 8, Men Y, (N=48, GI) | 64 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Baseline, Men A | 3.06 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 8, Men A, | 34 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 29, Men W-135 | 79 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 29, Men A, (N=48, G I) | 113 Titer |
| III: Meningococcal-naive | Geometric Mean Titer After Booster Vaccination | Day 29, Men Y | 110 Titer |
Comparison: Day 1, Men A, Pairwise comparison of geometric mean titer95% CI: [1.39, 4.1]ANOVA
Comparison: Day 1, Men A, Pairwise comparison of geometric mean titer95% CI: [0.42, 1.2]ANOVA
Comparison: Day 1, Men A, Pairwise comparison of geometric mean titer95% CI: [0.98, 2.9]ANOVA
Comparison: Day 8, Men A, Pairwise comparison of geometric mean titer95% CI: [0.59, 2.91]ANOVA
Comparison: Day 8, Men A, Pairwise comparison of geometric mean titer95% CI: [11, 52]ANOVA
Comparison: Day 8, Men A, Pairwise comparison of geometric mean titer95% CI: [14, 69]ANOVA
Comparison: Day 29, Men A, Pairwise comparison of geometric mean titer95% CI: [0.7, 2.42]ANOVA
Comparison: Day 29, Men A, Pairwise comparison of geometric mean titer95% CI: [3.01, 10]ANOVA
Comparison: Day 29, Men A, Pairwise comparison of geometric mean titer95% CI: [3.86, 13]ANOVA
Comparison: Day 1, Men C, Pairwise comparison of geometric mean titer95% CI: [1.4, 4.99]ANOVA
Comparison: Day 1, Men C, Pairwise comparison of geometric mean titer95% CI: [0.56, 1.97]ANOVA
Comparison: Day 1, Men C, Pairwise comparison of geometric mean titer95% CI: [1.47, 5.27]ANOVA
Comparison: Day 8, Men C, Pairwise comparison of geometric mean titer95% CI: [0.23, 1.13]ANOVA
Comparison: Day 8, Men C, Pairwise comparison of geometric mean titer95% CI: [21, 97]ANOVA
Comparison: Day 8, Men C, Pairwise comparison of geometric mean titer95% CI: [10, 51]ANOVA
Comparison: Day 29, Men C, Pairwise comparison of geometric mean titer95% CI: [0.2, 0.82]ANOVA
Comparison: Day 29, Men C, Pairwise comparison of geometric mean titer95% CI: [12, 48]ANOVA
Comparison: Day 29, Men C, Pairwise comparison of geometric mean titer95% CI: [4.69, 20]ANOVA
Comparison: Day 1, Men W-135, Pairwise comparison of geometric mean titer95% CI: [0.55, 2.21]ANOVA
Comparison: Day 1, Men W-135, Pairwise comparison of geometric mean titer95% CI: [1.27, 4.96]ANOVA
Comparison: Day 1, Men W-135, Pairwise comparison of geometric mean titer95% CI: [1.38, 5.57]ANOVA
Comparison: Day 8, Men W-135, Pairwise comparison of geometric mean titer95% CI: [0.28, 1.04]ANOVA
Comparison: Day 8, Men W-135, Pairwise comparison of geometric mean titer95% CI: [26, 94]ANOVA
Comparison: Day 8, Men W-135, Pairwise comparison of geometric mean titer95% CI: [14, 52]ANOVA
Comparison: Day 29, Men W-135, Pairwise comparison of geometric mean titer95% CI: [0.34, 1.04]ANOVA
Comparison: Day 29, Men W-135, Pairwise comparison of geometric mean titer95% CI: [20, 60]ANOVA
Comparison: Day 29, Men W-135, Pairwise comparison of geometric mean titer95% CI: [12, 36]ANOVA
Comparison: Day 1, Men Y, Pairwise comparison of geometric mean titer95% CI: [0.48, 1.69]ANOVA
Comparison: Day 1, Men Y, Pairwise comparison of geometric mean titer95% CI: [1.94, 6.74]
Comparison: Day 1, Men Y, Pairwise comparison of geometric mean titer95% CI: [1.71, 6.13]ANOVA
Comparison: Day 8, Men Y, Pairwise comparison of geometric mean titer95% CI: [0.16, 0.66]ANOVA
Comparison: Day 8, Men Y, Pairwise comparison of geometric mean titer95% CI: [61, 241]ANOVA
Comparison: Day 8, Men Y, Pairwise comparison of geometric mean titer95% CI: [20, 80]ANOVA
Comparison: Day 29, Men Y, Pairwise comparison of geometric mean titer95% CI: [0.32, 1.05]ANOVA
Comparison: Day 29, Men Y, Pairwise comparison of geometric mean titer95% CI: [18, 60]ANOVA
Comparison: Day 29, Men Y, Pairwise comparison of geometric mean titer95% CI: [10, 35]ANOVA
Primary
Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination
Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) \>= 8 \[i.e. percentage of subjects with hsBA titer \>=8\] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Time frame: Day 1 (5 years after primary vaccination)
Population: Full analysis set (all subjects who had no major protocol violation as defined prior to database lock).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men A | 30 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men C | 76 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men W-135 | 72 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men Y | 76 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men Y | 50 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men A | 44 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men W-135 | 56 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men C | 62 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men Y | 55 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men C | 51 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men W-135 | 51 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Men A | 11 Percentage of participants |
Secondary
Geometric Mean Ratio After Booster Vaccination
Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1
Time frame: Day 8 and Day 29 (at 5 Years After Primary Vaccination)
Population: full analysis set
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men A (Day 8:1) | 205 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men A (Day 29:1), N=48, N=49, N=50 | 155 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men C (Day 8:1) | 78 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men C (Day 29:1) | 60 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men W-135 (Day 8:1) | 58 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men W-135 (Day 29:1) | 56 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men Y (Day 8:1), N=48, N=49, N=50 | 96 Geometric mean ratio |
| I:MenACWY | Geometric Mean Ratio After Booster Vaccination | Men Y (Day 29:1) | 74 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men C (Day 8:1) | 1.85 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men Y (Day 8:1), N=48, N=49, N=50 | 2.69 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men C (Day 29:1) | 2.64 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men W-135 (Day 8:1) | 2.92 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men W-135 (Day 29:1) | 4.06 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men A (Day 8:1) | 6.1 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men A (Day 29:1), N=48, N=49, N=50 | 20 Geometric mean ratio |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Ratio After Booster Vaccination | Men Y (Day 29:1) | 8.12 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men C (Day 8:1) | 9.48 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men A (Day 29:1), N=48, N=49, N=50 | 37 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men A (Day 8:1) | 11 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men C (Day 29:1) | 17 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men Y (Day 8:1), N=48, N=49, N=50 | 7.29 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men W-135 (Day 29:1) | 7.48 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men W-135 (Day 8:1) | 5.95 Geometric mean ratio |
| III: Meningococcal-naive | Geometric Mean Ratio After Booster Vaccination | Men Y (Day 29:1) | 13 Geometric mean ratio |
Secondary
Geometric Mean Titer at 5 Years After Primary Vaccination
Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Time frame: Day 1 (5 years after primary vaccination )
Population: Full analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| I:MenACWY | Geometric Mean Titer at 5 Years After Primary Vaccination | Men A | 5.21 Titer |
| I:MenACWY | Geometric Mean Titer at 5 Years After Primary Vaccination | Men C | 20 Titer |
| I:MenACWY | Geometric Mean Titer at 5 Years After Primary Vaccination | Men W-135 | 28 Titer |
| I:MenACWY | Geometric Mean Titer at 5 Years After Primary Vaccination | Men Y | 27 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer at 5 Years After Primary Vaccination | Men Y | 7.67 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer at 5 Years After Primary Vaccination | Men A | 7.56 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer at 5 Years After Primary Vaccination | Men W-135 | 12 Titer |
| II:Licensed Polysacharide Meningococcal Vaccine | Geometric Mean Titer at 5 Years After Primary Vaccination | Men C | 19 Titer |
| III: Meningococcal-naive | Geometric Mean Titer at 5 Years After Primary Vaccination | Men Y | 9.38 Titer |
| III: Meningococcal-naive | Geometric Mean Titer at 5 Years After Primary Vaccination | Men C | 7.62 Titer |
| III: Meningococcal-naive | Geometric Mean Titer at 5 Years After Primary Vaccination | Men W-135 | 11 Titer |
| III: Meningococcal-naive | Geometric Mean Titer at 5 Years After Primary Vaccination | Men A | 3 Titer |
Secondary
Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination
Local and systemic reactions were solicited to assess safety and tolerability of vaccination
Time frame: Up to Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Sytemic Reactions (any-total) | 31 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Pain (any) | 29 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Myalgia (any) | 16 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Chills (any) | 7 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Local Reactions (any-total) | 30 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Malaise (any) | 10 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Nausea (any) | 8 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Fever >= 38C | 0 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Erythema (any) | 8 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Analgesic antipyretic medication used | 10 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Headache (any) | 21 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Induration (any) | 5 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Stayed at home | 0 participants |
| I:MenACWY | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Arthalgia (any) | 3 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Fever >= 38C | 0 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Local Reactions (any-total) | 32 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Pain (any) | 27 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Erythema (any) | 8 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Induration (any) | 8 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Sytemic Reactions (any-total) | 25 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Chills (any) | 5 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Nausea (any) | 9 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Malaise (any) | 11 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Myalgia (any) | 13 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Arthalgia (any) | 5 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Headache (any) | 17 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Analgesic antipyretic medication used | 8 participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Stayed at home | 2 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Myalgia (any) | 17 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Induration (any) | 5 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Local Reactions (any-total) | 40 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Arthalgia (any) | 6 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Erythema (any) | 15 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Analgesic antipyretic medication used | 9 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Headache (any) | 31 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Pain (any) | 33 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Nausea (any) | 11 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Chills (any) | 3 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Stayed at home | 2 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Malaise (any) | 15 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Sytemic Reactions (any-total) | 38 participants |
| III: Meningococcal-naive | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Fever >= 38C | 1 participants |
Secondary
Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Time frame: Day 7, Day 28 post booster (5 years after primary vaccination)
Population: Full Analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men A | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men A | 98 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men C | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men C | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men W-135 | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men W-135 | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men Y | 98 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men Y | 100 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men C | 82 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men Y | 78 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men C | 90 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men W-135 | 86 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men W-135 | 94 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men A | 76 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men A | 94 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men Y | 100 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men C | 94 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men A | 92 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men A | 66 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men C | 98 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men Y | 92 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men W-135 | 94 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 7 post booster, Men W-135 | 92 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Day 28 post booster, Men Y | 100 Percentage of participants |
Secondary
Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination
Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) \>= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y
Time frame: Day 1 (5 years after primary vaccination )
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men A | 34 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men C | 84 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men W-135 | 80 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men Y | 76 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men Y | 60 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men A | 50 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men W-135 | 58 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men C | 68 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men Y | 60 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men C | 70 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men W-135 | 55 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Men A | 23 Percentage of participants |
Secondary
Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination
Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) \>= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Time frame: Day 7, Day 28 post booster (5 years after primary vaccination)
Population: Full Analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men A | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men A | 98 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men C | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men C | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men W-135 | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men W-135 | 100 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men Y | 98 Percentage of participants |
| I:MenACWY | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men Y | 100 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men C | 78 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men Y | 76 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men C | 84 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men W-135 | 84 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men W-135 | 92 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men A | 73 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men A | 94 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men Y | 96 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men C | 90 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men A | 92 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men A | 64 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men C | 98 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men Y | 90 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men W-135 | 94 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 7 post booster, Men W-135 | 88 Percentage of participants |
| III: Meningococcal-naive | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Day 28 post booster, Men Y | 98 Percentage of participants |
Secondary
Percentage of Subjects With hSBA Seroresponse After Booster Vaccination
For a subject with hSBA titer \<4 at baseline, seroresponse is defined as a postvaccination hSBA titer \>=8; and for a subject with hSBA titer \>=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y.
Time frame: Day 8, Day 29 (5 years after primary vaccination)
Population: Full analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men A, Day 8 | 100 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men A, Day 29 | 100 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men C, Day 8 | 96 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men C, Day 29 | 96 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men W-135, Day 8 | 96 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men W-135, Day 29 | 98 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men Y, Day 8, (N=48, G I) | 94 Percentage of participants |
| I:MenACWY | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men Y, Day 29 | 94 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men C, Day 8 | 16 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men Y, Day 8, (N=48, G I) | 33 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men C, Day 29 | 31 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men W-135, Day 8 | 37 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men W-135, Day 29 | 47 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men A, Day 8 | 51 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men A, Day 29 | 76 Percentage of participants |
| II:Licensed Polysacharide Meningococcal Vaccine | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men Y, Day 29 | 55 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men C, Day 8 | 62 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men A, Day 29 | 90 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men A, Day 8 | 60 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men C, Day 29 | 80 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men Y, Day 8, (N=48, G I) | 54 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men W-135, Day 29 | 58 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men W-135, Day 8 | 48 Percentage of participants |
| III: Meningococcal-naive | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | Men Y, Day 29 | 76 Percentage of participants |