| Primary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. | The per-protocol analysis set (PPAS) was a subset of the full analysis set (FAS). The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
| | | Title | Denominators | Categories |
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| Serogroup A: Day 1 | | | | Serogroup A: Day 31 | |
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| Primary | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). hSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer <1:8 as a post-vaccination titer of >=1:16 and for a participant with a pre-vaccination titer >=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). rSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer <1:8 as a post-vaccination titer of >=1:32 and for a participant with a pre-vaccination titer >=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid | Geometric Mean Concentrations (GMCs) of anti-tetanus toxoid antibodies was measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent assay. | The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported. | Posted | | Geometric Mean | 95% Confidence Interval | International units/milliliter | | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination. | The SafAS included participants who received the study vaccine. | Posted | | Count of Participants | | Participants | | Up to 30 minutes post-vaccination on Day 1 | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited injection site reactions included injection site tenderness, injection site erythema and injection site swelling. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. | The SafAS included participants who received the study vaccine. | Posted | | Count of Participants | | Participants | | Up to 7 days post-vaccination on Day 1 | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Number of Participants With Unsolicited Adverse Events | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. | The SafAS included participants who received the study vaccine. | Posted | | Count of Participants | | Participants | | Up to 30 days post-vaccination on Day 1 | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. | The SafAS included participants who received the study vaccine. | Posted | | Count of Participants | | Participants | | From vaccination (Day 1) up to 30 days post vaccination, 31 days | | | | ID | Title | Description |
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| OG000 | MenACYW Conjugate Vaccine | Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. |
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