Meningococcal Disease
Conditions
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Toddlers, Children, Persistence, Boost
Brief summary
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.
Interventions
BIOLOGICALMenACWY-CRM
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Months to 45 Months
Healthy volunteers
No
Inclusion criteria
Children eligible to be enrolled in the study were those * whose parents provide written informed consent; * were in generally good health based on the clinical judgment of the investigators; * subjects were 22-45 months of age at the time of enrollment into V59P22E1; * subject who had participated in the parent V59P22 study.
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | 1 month post vaccination | The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y |
| Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | From 13-33 months post last vaccination in parent study (V59P22) | The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA) |
| Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster | The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y. |
| Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster vaccination | The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y. |
| Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | 1 month after vaccination | The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | From 13-33 months post last vaccination in parent study (V59P22) | The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y |
| Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination | Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y |
| Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination | Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y |
| Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Day 1-7 after vaccination | The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine. |
| Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Day 1-28 after vaccination | The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine. |
Countries
Germany
Participant flow
Recruitment details
Subjects for this extension study were enrolled from only sites in Germany that participated in the parent study.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY (2 Primary +1 Booster Dose) Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. | 74 |
| MenACWY (1 Primary + 1 Booster Dose) Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. | 66 |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study. | 65 |
| Total | 205 |
Baseline characteristics
| Characteristic | MenACWY (2 Primary +1 Booster Dose) | MenACWY (1 Primary + 1 Booster Dose) | MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Total |
|---|---|---|---|---|
| Age, Continuous | 36.7 months STANDARD_DEVIATION 5.3 | 37.4 months STANDARD_DEVIATION 5.6 | 37.9 months STANDARD_DEVIATION 5.3 | 37.3 months STANDARD_DEVIATION 5.4 |
| Sex: Female, Male Female | 34 Participants | 30 Participants | 37 Participants | 101 Participants |
| Sex: Female, Male Male | 40 Participants | 36 Participants | 28 Participants | 104 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 | 33 / 53 | 31 / 44 | 30 / 43 |
| serious Total, serious adverse events | 0 / 53 | 0 / 44 | 0 / 43 |
Outcome results
Primary
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Time frame: 1 month post booster vaccination
Population: The analysis was done on the per-protocol dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup A) | 2.82 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup A) | 182 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup C) N=52,40 | 3.92 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup C) N=52,40 | 541 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup W-135) | 9.37 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup W-135) | 799 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup Y) | 6.79 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup Y) | 650 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup Y) | 676 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup A) | 2.52 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup W-135) | 12 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup A) | 214 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup Y) | 6.04 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup C) N=52,40 | 3.91 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup W-135) | 1267 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup C) N=52,40 | 968 Titers |
Primary
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
Time frame: 1 month post vaccination
Population: The analysis was done on the per-protocol dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | Pre-vaccination (Serogroup A) | 2 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | 1 month post vaccination (Serogroup A) | 20 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | Pre-vaccination (Serogroup C) N=39 | 4.83 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | 1 month post vaccination (Serogroup C) N=39 | 1530 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | Pre-vaccination (Serogroup W-135) | 2.82 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | 1 month post vaccination (Serogroup W-135) | 54 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | Pre-vaccination (Serogroup Y) | 3.05 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine | 1 month post vaccination (Serogroup Y) | 54 Titers |
Primary
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Time frame: 1 month after vaccination
Population: The analysis was done on the per-protocol dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | Pre-vaccination (Serogroup A) | 0 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | 1 month post vaccination (Serogroup A) | 61 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | Pre-vaccination (Serogroup C) N=39 | 36 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | 1 month post vaccination (Serogroup C) N=39 | 100 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | Pre-vaccination (Serogroup W-135) | 12 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | 1 month post vaccination (Serogroup W-135) | 95 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | Pre-vaccination (Serogroup Y) | 20 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination | 1 month post vaccination (Serogroup Y) | 95 Percentages of subjects |
Primary
Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Time frame: From 13-33 months post last vaccination in parent study (V59P22)
Population: The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup W-135) | 50 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup A) | 13 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup Y) | 40 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup C)(N=52,40,42) | 27 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup W-135) | 63 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup C)(N=52,40,42) | 25 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup Y) | 39 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup A) | 7 Percentages of subjects |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup Y) | 19 Percentages of subjects |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup A) | 0 Percentages of subjects |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup C)(N=52,40,42) | 36 Percentages of subjects |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup W-135) | 12 Percentages of subjects |
Primary
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Time frame: 1 month post booster
Population: The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup A) | 13 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup A) | 96 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup C) N=52,40 | 27 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup C) N=52,40 | 100 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup W-135) | 50 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup W-135) | 100 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup Y) | 40 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup Y) | 100 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup Y) | 100 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup A) | 7 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup W-135) | 63 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup A) | 98 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup Y) | 39 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | Pre-booster (Serogroup C) N=52,40 | 25 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup W-135) | 100 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination | 1 month post booster (Serogroup C) N=52,40 | 100 Percentages of subjects |
Secondary
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time frame: 1 month post vaccination
Population: The analysis was done on the per-protocol dataset
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup A) | 214 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup C) N=40,39 | 968 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup W-135) | 1267 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup Y) | 676 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup Y) | 54 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup A) | 20 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup W-135) | 54 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | 1 month post vaccination (Serogroup C) N=40,39 | 1530 Titers |
Secondary
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Time frame: Day 1-7 after vaccination
Population: The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any other | 5 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site pain | 10 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Arthralgia | 1 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Fever (≥38°C) | 8 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Analgesic Antipyretic Medication Used | 4 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Headache | 5 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site induration | 6 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any Solicited Local | 33 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site erythema | 14 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Change in eating habits | 6 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any Solicited Systemic | 28 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Temperature (≥40°C) (N= 52,41,41) | 0 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Rash | 0 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Stayed at home | 4 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Vomiting | 0 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Sleepiness | 10 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any Solicited Systemic | 18 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Fever (≥38°C) | 7 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any other | 7 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site induration | 8 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Stayed at home | 5 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Vomiting | 2 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Analgesic Antipyretic Medication Used | 6 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Temperature (≥40°C) (N= 52,41,41) | 0 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Sleepiness | 13 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Arthralgia | 5 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site pain | 15 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Headache | 6 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Change in eating habits | 8 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site erythema | 17 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Rash | 2 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any Solicited Local | 30 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Temperature (≥40°C) (N= 52,41,41) | 2 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Sleepiness | 10 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any Solicited Local | 30 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site pain | 13 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site erythema | 15 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Injection site induration | 7 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any Solicited Systemic | 25 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Arthralgia | 4 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Headache | 1 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Vomiting | 1 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Change in eating habits | 6 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Rash | 1 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Fever (≥38°C) | 7 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Any other | 5 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Stayed at home | 2 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination | Analgesic Antipyretic Medication Used | 5 Participants |
Secondary
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
Time frame: Day 1-28 after vaccination
Population: The analysis was done on the safety dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | AEs leading to premature withdrawal | 0 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Serious AE | 0 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Any AE | 11 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | At least possibly related AEs | 0 Participants |
| MenACWY (2 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Deaths | 0 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Serious AE | 0 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Any AE | 10 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | At least possibly related AEs | 2 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | AEs leading to premature withdrawal | 0 Participants |
| MenACWY (1 Primary + 1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Deaths | 0 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Deaths | 0 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | AEs leading to premature withdrawal | 0 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Any AE | 9 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | Serious AE | 0 Participants |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination | At least possibly related AEs | 1 Participants |
Secondary
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Time frame: 1 month post vaccination
Population: The analysis was done on the per-protocol dataset
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8(Serogroup A) | 98 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8 (Serogroup C) N=40,39 | 100 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8(Serogroup W-135) | 100 Percentages of subjects |
| MenACWY (2 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8 (Serogroup Y) | 100 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8 (Serogroup Y) | 95 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8(Serogroup A) | 61 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8(Serogroup W-135) | 95 Percentages of subjects |
| MenACWY (1 Primary + 1 Booster Dose) | Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine | hSBA ≥1:8 (Serogroup C) N=40,39 | 100 Percentages of subjects |
Secondary
Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Time frame: From 13-33 months post last vaccination in parent study (V59P22)
Population: The analysis was done on the per-protocol persistence dataset.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY (2 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup A) | 2.82 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup C) N=52,40 | 3.94 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup W-135) | 9.36 Titers |
| MenACWY (2 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup Y) | 6.79 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup Y) | 6.03 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup A) | 2.52 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup W-135) | 12 Titers |
| MenACWY (1 Primary + 1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup C) N=52,40 | 3.93 Titers |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup Y) | 2.99 Titers |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup C) N=52,40 | 4.94 Titers |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup W-135) | 2.81 Titers |
| MenC (1 Primary Dose) +MenACWY (1 Booster Dose) | Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine | 13-33 months persistence (Serogroup A) | 2 Titers |