| 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) | 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. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | From 13-33 months post last vaccination in parent study (V59P22) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| 13-33 months persistence (Serogroup A) | | | Title | Measurements |
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| - OG00013(6 to 26)
- OG0017(2 to 20)
- OG0020(0 to 8)
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| | 13-33 months persistence (Serogroup C)(N=52,40,42) |
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| 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 | The analysis was done on the per-protocol persistence dataset. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | From 13-33 months post last vaccination in parent study (V59P22) | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month post booster | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | The analysis was done on the per-protocol dataset. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post booster vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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 | The analysis was done on the per-protocol dataset. | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month after vaccination | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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 | The analysis was done on the per-protocol dataset. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post vaccination | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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 | The analysis was done on the per-protocol dataset | Posted | | Number | 95% Confidence Interval | Percentages of subjects | | 1 month post vaccination | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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 | The analysis was done on the per-protocol dataset | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 1 month post vaccination | | | | ID | Title | Description |
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| OG000 | 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 | | OG001 | 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 |
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| 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. | The analysis was done on the safety dataset i.e all subjects who received the study vaccine and provided some post-vaccination safety data | Posted | | Number | | Participants | | Day 1-7 after vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | The analysis was done on the safety dataset. | Posted | | Number | | Participants | | Day 1-28 after vaccination | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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