Trial Outcomes & Findings for A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules (NCT NCT04440176)
NCT ID: NCT04440176
Last Updated: 2025-01-08
Results Overview
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.
COMPLETED
PHASE2
309 participants
Baseline (before vaccination 1)
2025-01-08
Participant Flow
A total of 309 participants were enrolled and randomized to receive study vaccination in this study out of which, 300 participants were vaccinated.
Participants aged greater than or equal to (\>=) 11 years to less than (\<) 15 years were randomized to receive Neisseria meningitidis Group A, B, C, W, and Y (MenABCWY) vaccine either at 0-and 12-Month schedule (Group 1) or at 0- and 36-Month schedule (Group 2).
Participant milestones
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
Participants were randomized to receive 0.5 milliliter (mL) of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2).
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
155
|
154
|
|
Overall Study
Safety Population
|
146
|
148
|
|
Overall Study
COMPLETED
|
102
|
102
|
|
Overall Study
NOT COMPLETED
|
53
|
52
|
Reasons for withdrawal
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
Participants were randomized to receive 0.5 milliliter (mL) of MenABCWY vaccine intramuscularly on Day 1/Month 0 (Vaccination 1) and at Month 12 (Vaccination 2).
|
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).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
3
|
|
Overall Study
Withdrawal by parent/guardian
|
4
|
5
|
|
Overall Study
Adverse Event
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
22
|
23
|
|
Overall Study
Medication error without associated adverse event
|
0
|
1
|
|
Overall Study
No longer met eligibility criteria
|
7
|
1
|
|
Overall Study
Other
|
1
|
2
|
|
Overall Study
Protocol deviation
|
6
|
8
|
|
Overall Study
Randomized but not vaccinated
|
6
|
3
|
Baseline Characteristics
A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
Baseline characteristics by cohort
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
Group 2 (MenABCWY 0- and 36-Month Schedule)
n=148 Participants
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).
|
Total
n=294 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.5 Years
STANDARD_DEVIATION 0.65 • n=5 Participants
|
11.5 Years
STANDARD_DEVIATION 0.65 • n=7 Participants
|
11.5 Years
STANDARD_DEVIATION 0.65 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (before vaccination 1)Population: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=116 Participants
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).
|
|---|---|
|
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
A22
|
7.0 Percentage of participants
Interval 3.1 to 13.4
|
|
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
A56
|
2.6 Percentage of participants
Interval 0.5 to 7.4
|
|
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
B24
|
1.7 Percentage of participants
Interval 0.2 to 6.1
|
|
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
B44
|
0.9 Percentage of participants
Interval 0.0 to 4.7
|
PRIMARY outcome
Timeframe: 1 month after vaccination 2 (second dose of MenABCWY)Population: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=116 Participants
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).
|
|---|---|
|
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
A22
|
99.1 Percentage of participants
Interval 95.2 to 100.0
|
|
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
A56
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
|
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
B24
|
98.2 Percentage of participants
Interval 93.8 to 99.8
|
|
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
B44
|
96.6 Percentage of participants
Interval 91.4 to 99.1
|
PRIMARY outcome
Timeframe: Baseline (before vaccination 1)Population: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=99 Participants
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).
|
|---|---|
|
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule
A22
|
10.0 Percentage of participants
Interval 4.7 to 18.1
|
|
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule
A56
|
1.1 Percentage of participants
Interval 0.0 to 5.7
|
|
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule
B24
|
2.0 Percentage of participants
Interval 0.2 to 7.1
|
|
Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MenB Test Strains at Baseline: 0 and 36 Month Schedule
B44
|
1.0 Percentage of participants
Interval 0.0 to 5.5
|
PRIMARY outcome
Timeframe: 1 Month After Vaccination 3 (second dose of MenABCWY)Population: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=99 Participants
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).
|
|---|---|
|
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
A22
|
100.0 Percentage of participants
Interval 96.3 to 100.0
|
|
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
A56
|
100.0 Percentage of participants
Interval 96.2 to 100.0
|
|
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
B24
|
100.0 Percentage of participants
Interval 96.3 to 100.0
|
|
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
B44
|
100.0 Percentage of participants
Interval 96.3 to 100.0
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 1 (first dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting Adverse Events (AEs) Within 30 Days After Vaccination 1: 0 and 12 Month Schedule
|
28.8 Percentage of participants
Interval 21.6 to 36.8
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 2 (second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
|
15.7 Percentage of participants
Interval 9.7 to 23.4
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 1 (first dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
|
27.7 Percentage of participants
Interval 20.7 to 35.7
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 2 (saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
|
13.8 Percentage of participants
Interval 8.4 to 21.0
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 3 (second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=103 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
|
19.4 Percentage of participants
Interval 12.3 to 28.4
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
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
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
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
MAEs
|
6.2 Percentage of participants
Interval 2.9 to 11.4
|
|
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
NDCMCs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 2 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 3.0
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
MAEs
|
5.0 Percentage of participants
Interval 1.8 to 10.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 12 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
MAEs
|
7.4 Percentage of participants
Interval 3.8 to 12.9
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 1: 0 and 36 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 2 (Saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
MAEs
|
6.9 Percentage of participants
Interval 3.2 to 12.7
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 2: 0 and 36 Month Schedule
NDCMCs
|
0.8 Percentage of participants
Interval 0.0 to 4.2
|
PRIMARY outcome
Timeframe: Within 30 days after vaccination 3 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=103 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 3.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
MAEs
|
1.9 Percentage of participants
Interval 0.2 to 6.8
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Vaccination 3: 0 and 36 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 3.5
|
PRIMARY outcome
Timeframe: Within 30 Days after any MenABCWY vaccinationPopulation: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
|
34.9 Percentage of participants
Interval 27.2 to 43.3
|
PRIMARY outcome
Timeframe: Within 30 days after any MenABCWY vaccinationPopulation: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
|
32.4 Percentage of participants
Interval 25.0 to 40.6
|
PRIMARY outcome
Timeframe: Within 30 days after any MenABCWY vaccinationPopulation: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
MAEs
|
10.3 Percentage of participants
Interval 5.9 to 16.4
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 12 Month Schedule
NDCMCs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
PRIMARY outcome
Timeframe: Within 30 days after any MenABCWY vaccinationPopulation: Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
MAEs
|
8.8 Percentage of participants
Interval 4.8 to 14.6
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs Within 30 Days After Any MenABCWY Vaccination: 0 and 36 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
|
30.8 Percentage of participants
Interval 23.5 to 39.0
|
PRIMARY outcome
Timeframe: Vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
|
29.1 Percentage of participants
Interval 21.9 to 37.1
|
PRIMARY outcome
Timeframe: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
MAEs
|
8.2 Percentage of participants
Interval 4.3 to 13.9
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 12 Month Schedule
NDCMCs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
PRIMARY outcome
Timeframe: From vaccination 1 through 1 month after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
MAEs
|
8.8 Percentage of participants
Interval 4.8 to 14.6
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 1 Month After Vaccination 1: 0 and 36 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
PRIMARY outcome
Timeframe: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
|
15.7 Percentage of participants
Interval 9.7 to 23.4
|
PRIMARY outcome
Timeframe: From vaccination 2 through 1 month after vaccination 2 (Saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
|
16.2 Percentage of participants
Interval 10.3 to 23.6
|
PRIMARY outcome
Timeframe: From vaccination 2 through 1 month after vaccination 2 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 3.0
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
MAEs
|
5.0 Percentage of participants
Interval 1.8 to 10.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 12 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: From vaccination 2 through 1 month after vaccination 2 (Saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.8
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
MAEs
|
6.9 Percentage of participants
Interval 3.2 to 12.7
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 1 Month After Vaccination 2: 0 and 36 Month Schedule
NDCMCs
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
PRIMARY outcome
Timeframe: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=103 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting AEs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
|
19.4 Percentage of participants
Interval 12.3 to 28.4
|
PRIMARY outcome
Timeframe: From vaccination 3 through 1 month after vaccination 3 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=103 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 3.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
MAEs
|
3.9 Percentage of participants
Interval 1.1 to 9.6
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 3 Through 1 Month After Vaccination 3: 0 and 36 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 3.5
|
PRIMARY outcome
Timeframe: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=145 Participants
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).
|
|---|---|
|
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
SAEs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
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
MAEs
|
16.6 Percentage of participants
Interval 10.9 to 23.6
|
|
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
NDCMCs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
PRIMARY outcome
Timeframe: From 1 month after vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
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
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
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
MAEs
|
14.2 Percentage of participants
Interval 9.0 to 20.9
|
|
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
NDCMCs
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
PRIMARY outcome
Timeframe: From 1 month after vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=118 Participants
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).
|
|---|---|
|
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
SAEs
|
0.8 Percentage of participants
Interval 0.0 to 4.6
|
|
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
MAEs
|
8.5 Percentage of participants
Interval 4.1 to 15.0
|
|
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
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 3.1
|
PRIMARY outcome
Timeframe: From 1 month after vaccination 2 through 6 months after vaccination 2 (Saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=128 Participants
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).
|
|---|---|
|
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
SAEs
|
1.6 Percentage of participants
Interval 0.2 to 5.5
|
|
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
MAEs
|
9.4 Percentage of participants
Interval 4.9 to 15.8
|
|
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
NDCMCs
|
3.1 Percentage of participants
Interval 0.9 to 7.8
|
PRIMARY outcome
Timeframe: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
SAEs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
MAEs
|
23.3 Percentage of participants
Interval 16.7 to 31.0
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 12 Month Schedule
NDCMCs
|
1.4 Percentage of participants
Interval 0.2 to 4.9
|
PRIMARY outcome
Timeframe: From vaccination 1 through 6 months after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
SAEs
|
0.0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
MAEs
|
19.6 Percentage of participants
Interval 13.5 to 26.9
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 1 Through 6 Months After Vaccination 1: 0 and 36 Month Schedule
NDCMCs
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
PRIMARY outcome
Timeframe: From vaccination 2 through 6 months after vaccination 2 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
SAEs
|
0.8 Percentage of participants
Interval 0.0 to 4.5
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
MAEs
|
13.2 Percentage of participants
Interval 7.8 to 20.6
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 12 Month Schedule
NDCMCs
|
0.0 Percentage of participants
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: From vaccination 2 through 6 months after vaccination 2 (Saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
SAEs
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
MAEs
|
14.6 Percentage of participants
Interval 9.0 to 21.9
|
|
Percentage of Participants Reporting SAEs, MAEs and NDCMCs From Vaccination 2 Through 6 Months After Vaccination 2: 0 and 36 Month Schedule
NDCMCs
|
4.6 Percentage of participants
Interval 1.7 to 9.8
|
PRIMARY outcome
Timeframe: 30 minutes after vaccination 1 (First dose of MenABCWY)Population: 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.
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 12 Month Schedule
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
PRIMARY outcome
Timeframe: 30 minutes after vaccination 2 (Second dose of MenABCWY)Population: 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.
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 12 Month Schedule
|
0.0 Percentage of participants
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 30 minutes after vaccination 1 (First dose of MenABCWY)Population: 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.
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 1: 0 and 36 Month Schedule
|
0.7 Percentage of participants
Interval 0.0 to 3.7
|
PRIMARY outcome
Timeframe: 30 minutes after vaccination 2 (Saline)Population: 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.
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 2: 0 and 36 Month Schedule
|
1.5 Percentage of participants
Interval 0.2 to 5.4
|
PRIMARY outcome
Timeframe: 30 minutes after vaccination 3 (Second dose of MenABCWY)Population: 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.
Immediate AEs were defined as AEs occurring within the first 30 minutes after study intervention administration.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=103 Participants
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).
|
|---|---|
|
Percentage of Participants Reporting at Least 1 Immediate AE After Vaccination 3: 0 and 36 Month Schedule
|
2.9 Percentage of participants
Interval 0.6 to 8.3
|
PRIMARY outcome
Timeframe: Within 6 months after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 Participants
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).
|
|---|---|
|
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 12 Month Schedule
|
8.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Within 6 months after vaccination 1 (First dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=148 Participants
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).
|
|---|---|
|
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 1: 0 and 36 Month Schedule
|
8.1 Percentage of participants
|
PRIMARY outcome
Timeframe: Within 6 months after vaccination 2 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=121 Participants
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).
|
|---|---|
|
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 12 Month Schedule
|
8.3 Percentage of participants
|
PRIMARY outcome
Timeframe: Within 6 months after vaccination 2 (Saline)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=130 Participants
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).
|
|---|---|
|
Percentage of Participants Who Missed School or Work Because of AEs Within 6 Months After Vaccination 2: 0 and 36 Month Schedule
|
6.2 Percentage of participants
|
PRIMARY outcome
Timeframe: Within 1 month after vaccination 3 (Second dose of MenABCWY)Population: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=103 Participants
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).
|
|---|---|
|
Percentage of Participants Who Missed School or Work Because of AEs Within 1 Month After Vaccination 3: 0 and 36 Month Schedule
|
1.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (before vaccination 1) and 1 month after the first dose of MenABCWYPopulation: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=140 Participants
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).
|
|---|---|
|
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
MenA: Baseline
|
10.7 Percentage of participants
Interval 6.1 to 17.1
|
|
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
MenA: 1 month after the first dose of MenABCWY
|
98.6 Percentage of participants
Interval 94.9 to 99.8
|
|
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
MenC: Baseline
|
10.1 Percentage of participants
Interval 5.6 to 16.3
|
|
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
MenC: 1 month after the first dose of MenABCWY
|
79.3 Percentage of participants
Interval 71.6 to 85.7
|
|
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
MenW: Baseline
|
15.9 Percentage of participants
Interval 10.3 to 23.1
|
|
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
MenW: 1 month after the first dose of MenABCWY
|
98.6 Percentage of participants
Interval 94.9 to 99.8
|
|
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
MenY: Baseline
|
36.0 Percentage of participants
Interval 28.0 to 44.7
|
|
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
MenY: 1 month after the first dose of MenABCWY
|
99.3 Percentage of participants
Interval 96.1 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (before vaccination 1) and 1 month after the second dose of MenABCWYPopulation: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=116 Participants
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).
|
|---|---|
|
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
MenA: Baseline
|
6.9 Percentage of participants
Interval 3.0 to 13.1
|
|
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
MenA: 1 month after the second dose of MenABCWY
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
|
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
MenC: Baseline
|
9.6 Percentage of participants
Interval 4.9 to 16.5
|
|
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
MenC: 1 month after the second dose of MenABCWY
|
99.1 Percentage of participants
Interval 95.3 to 100.0
|
|
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
MenW: Baseline
|
16.7 Percentage of participants
Interval 10.3 to 24.8
|
|
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
MenW: 1 month after the second dose of MenABCWY
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
|
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
MenY: Baseline
|
32.7 Percentage of participants
Interval 24.2 to 42.2
|
|
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
MenY: 1 month after the second dose of MenABCWY
|
100.0 Percentage of participants
Interval 96.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (before vaccination 1) and 1 month after first dose of MenABCWYPopulation: 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.
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=144 Participants
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).
|
|---|---|
|
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
MenY: 1 month after the first dose of MenABCWY
|
99.3 Percentage of participants
Interval 96.2 to 100.0
|
|
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
MenA: Baseline
|
7.1 Percentage of participants
Interval 3.5 to 12.7
|
|
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
MenA: 1 month after the first dose of MenABCWY
|
100.0 Percentage of participants
Interval 97.5 to 100.0
|
|
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
MenC: Baseline
|
10.4 Percentage of participants
Interval 5.9 to 16.6
|
|
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
MenC: 1 month after the first dose of MenABCWY
|
80.4 Percentage of participants
Interval 73.0 to 86.6
|
|
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
MenW: Baseline
|
15.4 Percentage of participants
Interval 9.9 to 22.4
|
|
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
MenW: 1 month after the first dose of MenABCWY
|
98.6 Percentage of participants
Interval 95.1 to 99.8
|
|
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
MenY: Baseline
|
35.2 Percentage of participants
Interval 27.4 to 43.7
|
SECONDARY outcome
Timeframe: Baseline (before vaccination 1) and 1 month after second dose of MenABCWYPopulation: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=100 Participants
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).
|
|---|---|
|
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
MenA: Baseline
|
7.1 Percentage of participants
Interval 2.9 to 14.0
|
|
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
MenA: 1 month after the second dose of MenABCWY
|
100.0 Percentage of participants
Interval 96.2 to 100.0
|
|
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
MenC: Baseline
|
12.0 Percentage of participants
Interval 6.4 to 20.0
|
|
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
MenC: 1 month after the second dose of MenABCWY
|
100.0 Percentage of participants
Interval 95.7 to 100.0
|
|
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
MenW: Baseline
|
16.2 Percentage of participants
Interval 9.5 to 24.9
|
|
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
MenW: 1 month after the second dose of MenABCWY
|
100.0 Percentage of participants
Interval 95.9 to 100.0
|
|
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
MenY: Baseline
|
37.8 Percentage of participants
Interval 28.2 to 48.1
|
|
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
MenY: 1 month after the second dose of MenABCWY
|
100.0 Percentage of participants
Interval 95.9 to 100.0
|
SECONDARY outcome
Timeframe: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)Population: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=110 Participants
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).
|
|---|---|
|
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
A22: At 12 months
|
79.8 Percentage of participants
Interval 71.1 to 86.9
|
|
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
A56: At 12 months
|
86.0 Percentage of participants
Interval 77.9 to 91.9
|
|
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
B24: At 12 months
|
43.0 Percentage of participants
Interval 33.5 to 52.9
|
|
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
B44: At 12 months
|
55.5 Percentage of participants
Interval 45.7 to 64.9
|
|
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
A22: At 24 months
|
73.5 Percentage of participants
Interval 63.6 to 81.9
|
|
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
A56: At 24 months
|
75.0 Percentage of participants
Interval 64.9 to 83.4
|
|
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
B24: At 24 months
|
44.0 Percentage of participants
Interval 34.1 to 54.3
|
|
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
B44: At 24 months
|
50.5 Percentage of participants
Interval 40.4 to 60.6
|
SECONDARY outcome
Timeframe: At 12 months and 24 months after vaccination 2 (Second dose of MenABCWY)Population: 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).
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.
Outcome measures
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=111 Participants
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).
|
|---|---|
|
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
MenA: At 12 months
|
100.0 Percentage of participants
Interval 96.7 to 100.0
|
|
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
MenC: At 12 months
|
93.5 Percentage of participants
Interval 87.0 to 97.3
|
|
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
MenW: At 12 months
|
100.0 Percentage of participants
Interval 96.5 to 100.0
|
|
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
MenY: At 12 months
|
99.0 Percentage of participants
Interval 94.8 to 100.0
|
|
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
MenA: At 24 months
|
98.0 Percentage of participants
Interval 93.0 to 99.8
|
|
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
MenC: At 24 months
|
88.9 Percentage of participants
Interval 81.0 to 94.3
|
|
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
MenW: At 24 months
|
100.0 Percentage of participants
Interval 96.3 to 100.0
|
|
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
MenY: At 24 months
|
100.0 Percentage of participants
Interval 96.3 to 100.0
|
Adverse Events
Group 1 (MenABCWY 0- and 12-Month Schedule)
Group 2 (MenABCWY 0- and 36-Month Schedule)
Serious adverse events
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 participants at risk
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).
|
Group 2 (MenABCWY 0- and 36-Month Schedule)
n=148 participants at risk
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).
|
|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.68%
1/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Chest pain
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.68%
1/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.00%
0/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Cellulitis orbital
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.00%
0/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.00%
0/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.68%
1/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
Other adverse events
| Measure |
Group 1 (MenABCWY 0- and 12-Month Schedule)
n=146 participants at risk
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).
|
Group 2 (MenABCWY 0- and 36-Month Schedule)
n=148 participants at risk
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).
|
|---|---|---|
|
Investigations
Body temperature increased
|
2.1%
3/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
4.7%
7/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Injection site swelling
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.7%
4/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Injection site warmth
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.00%
0/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Pain
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
6.1%
9/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Pyrexia
|
7.5%
11/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
5.4%
8/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Vaccination site pain
|
2.1%
3/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
6.8%
10/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.0%
3/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Gastrointestinal disorders
Nausea
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.7%
4/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Gastrointestinal disorders
Vomiting
|
4.1%
6/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
4.1%
6/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
COVID-19
|
6.8%
10/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.7%
4/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Influenza
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
5/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Pharyngitis
|
3.4%
5/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.0%
3/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Suspected COVID-19
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
5/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
7.4%
11/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
4/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
3.4%
5/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
3.4%
5/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.1%
3/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.0%
3/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Metabolism and nutrition disorders
Overweight
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Nervous system disorders
Dizziness
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Nervous system disorders
Headache
|
7.5%
11/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
6.8%
10/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Psychiatric disorders
Depression
|
2.7%
4/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
4.1%
6/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
2.0%
3/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Psychiatric disorders
Insomnia
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Psychiatric disorders
Suicidal ideation
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.68%
1/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.00%
0/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Chills
|
2.1%
3/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.68%
1/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Fatigue
|
4.8%
7/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
4.1%
6/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Injection site erythema
|
3.4%
5/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
3.4%
5/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Injection site pain
|
10.3%
15/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
10.1%
15/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
General disorders
Injection site rash
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.68%
1/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.4%
2/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
0.00%
0/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.68%
1/146 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
1.4%
2/148 • Group 1: Up to 36 months; Group 2: Up to 37 months
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population set included all randomized participants who received at least 1 dose of the study intervention and had safety data reported after vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER