| Primary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titer >=Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MenB) Test Strains at Baseline: 0 and 12 Month Schedule | Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. Here, 'Post Vaccination 2 Evaluable Population'=PV2 EP and "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (before vaccination 1) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
| | | Title | Denominators | Categories |
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| A22 | | | | A56 | |
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| Primary | Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 2: 0 and 12 Month Schedule | Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 2 in participants who received MenABCWY at Month 0 and Month 12 were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 month after vaccination 2 (second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule | Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at baseline were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (before vaccination 1) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at 1 Month After Vaccination 3: 0 and 36 Month Schedule | Percentage of participants achieving hSBA titer >=LLOQ (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) for each of the 4 primary MenB test strains at 1 month after vaccination 3 (second dose of MenABCWY) in participants who received MenABCWY at Month 0 and Month 36. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 1 Month After Vaccination 3 (second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 1 (first dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 (second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 1 (first dose of MenABCWY) | | | | ID | Title | Description |
|---|
| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 (saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 3 (second dose of MenABCWY) | | | | ID | Title | Description |
|---|
| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAEs) and Newly Diagnosed Chronic Medical Condition (NDCMCs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a non-serious AE (other than serious AE) that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after vaccination 3 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 Days after any MenABCWY vaccination | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after any MenABCWY vaccination | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after any MenABCWY vaccination | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Within 30 days after any MenABCWY vaccination | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 1 safety population included all participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 1 safety population included all participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 1 safety population included all participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 1 safety population included all participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 2 through 1 month after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 2 through 1 month after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. AEs included both serious and all non-serious adverse events. | Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Follow-up safety population 1 included participants who received the first dose of study intervention and for whom safety information from Visit 2 up to Visit 4 in Groups 1 and 2 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Follow-up safety population 1 included participants who received the first dose of study intervention and for whom safety information from Visit 2 up to Visit 4 in Groups 1 and 2 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Follow-up safety population 2 included participants who received the second dose of study intervention (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 5 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From 1 Month After Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Follow-up safety population 2 included participants who received the second dose of study intervention (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 5 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. An SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life threatening; resulted in persistent disability/incapacity; congenital anomaly/birth defect and other important medical events. An MAE was defined as a nonserious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | From vaccination 2 through 6 months after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule | Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule | Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule | Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule | Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule | Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration. | Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 30 minutes after vaccination 3 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | | Percentage of participants | | Within 6 months after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. | Vaccination 1 safety population included participants who received the first dose of study intervention at Visit 1 and for whom safety information from Visit 1 up to Visit 4 was available in Groups 1 and 2. | Posted | | Number | | Percentage of participants | | Within 6 months after vaccination 1 (First dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | | Percentage of participants | | Within 6 months after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. | Vaccination 2 safety population included participants who received the second dose of study intervention at Visit 4 (MenABCWY for Group 1, saline for Group 2) and for whom safety information from Visit 4 up to Visit 7 (for Group 1) or Visit 9 (for Group 2) was available. | Posted | | Number | | Percentage of participants | | Within 6 months after vaccination 2 (Saline) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Primary | Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule | An AE was any untoward medical occurrence in a participant, temporally associated with the use of investigational product, whether or not considered related to the investigational product. | Vaccination 3 safety population included participants who received the third dose of study intervention at Visit 9 (MenABCWY for Group 2) and for whom safety information from Visit 9 through Visit 10 was available. | Posted | | Number | | Percentage of participants | | Within 1 month after vaccination 3 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Secondary | Percentage of Participants With hSBA Titer >= LLOQ for Each of the Meningococcal Group A, C, W, and Y (MenACWY) Test Strains at Baseline and 1 Month After the First Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 1 Evaluable Population | Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after first dose of MenABCWY in participants who received the first dose of MenABCWY were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows. | PV1 EP: all randomized participants, eligible throughout Visit 2, received study intervention at Visit 1 as randomized, had blood drawn for assay testing within required time frames at Month 0 (Visit 1; before Vaccination 1) and Month 1 (Visit 2; 1 month after the first vaccination: window 28-42 days) had at least 1 valid and determinate MenA/C/W/Y assay result at Visit 2, had received no prohibited vaccines or treatment through Visit 2 and had no important protocol deviations through Visit 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (before vaccination 1) and 1 month after the first dose of MenABCWY | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Secondary | Percentage of Participants With hSBA Titer >= LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After the Second Dose of MenABCWY: 0 and 12 Month Schedule-Post-Vaccination 2 Evaluable Population | Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after second dose of MenABCWY in participants who received the first and second dose of MenABCWY were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (before vaccination 1) and 1 month after the second dose of MenABCWY | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Secondary | Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After First Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 1 Evaluable Population | Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the MenACWY test strains at baseline and one month after first dose of MenABCWY in participants who received who received the first dose of MenABCWY were reported in this outcome measure. "Number analyzed" = number of participants evaluable at specific rows. | PV1 EP: all randomized participants, eligible throughout Visit 2, received study intervention at Visit 1 as randomized, had blood drawn for assay testing within required time frames at Month 0 (Visit 1; before Vaccination 1) and Month 1 (Visit 2; 1 month after the first vaccination: window 28-42 days) had at least 1 valid and determinate MenA/C/W/Y assay result at Visit 2, had received no prohibited vaccines or treatment through Visit 2 and had no important protocol deviations through Visit 2. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (before vaccination 1) and 1 month after first dose of MenABCWY | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Secondary | Percentage of Participants With hSBA Titer >=LLOQ for Each of the MenACWY Test Strains at Baseline and 1 Month After Second Dose of MenABCWY: 0 and 36 Month Schedule-Post-Vaccination 2 Evaluable Population | Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the meningococcal group A, C, W, and Y (MenACWY) test strains at baseline and one month after second dose of MenABCWY in participants who received the first and second dose of MenABCWY were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline (before vaccination 1) and 1 month after second dose of MenABCWY | | | | ID | Title | Description |
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| OG000 | Group 2 (MenABCWY 0- and 36-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1), and at Month 36 (Vaccination 3). Participants received 0.5 mL of placebo (normal saline) intramuscularly at Month 12 (Vaccination 2). |
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| Secondary | Percentage of Participants With hSBA Titer >=LLOQ for Each of the 4 Primary MenB Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule | Percentage of participants achieving hSBA titer >=LLOQ for each of the 4 primary MenB test strains (1:16 for strain A22 and 1:8 for strains A56, B24, and B44) at 12 and 24 months after the second dose of MenABCWY were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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| Secondary | Percentage of Participants With hSBA Titer >=LLOQ for Each ACWY Test Strains at 12 Months and 24 Months After Vaccination 2: 0 and 12 Month Schedule | Percentage of participants achieving hSBA titer >=LLOQ (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY serogroups) for each of the ACWY test (MenA, MenC, MenW, MenY) at 12 and 24 months after the second dose of MenABCWY2 were reported in this outcome measure. "Number of Participants Analyzed"= number of participants evaluable for this outcome measure and "Number analyzed" = number of participants evaluable at specific rows. | PV2 EP : all randomized participants, eligible throughout 1 month after second dose of MenABCWY; received vaccine at visit(V)1 for groups(G) 1 and 2,V4 for G1, V9 for G2;blood drawn for assay testing at Month 0 (V1;before dose 1)and at 1 month after dose 2(V5 for G1,V10 for G2:window 28-42 days);at least 1 determinate MenA/C/W/Y or MenB assay result at V5 and V10;received no prohibited treatment and had no protocol deviations through V5(G1)or V10(G2). | Posted | | Number | 95% Confidence Interval | Percentage of participants | | At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY) | | | | ID | Title | Description |
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| OG000 | Group 1 (MenABCWY 0- and 12-Month Schedule) | Participants were randomized to receive 0.5 mL of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2). |
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