Trial Outcomes & Findings for A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults (NCT NCT00450437)
NCT ID: NCT00450437
Last Updated: 2015-01-28
Results Overview
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3539 participants
Primary outcome timeframe
28 days after vaccination
Results posted on
2015-01-28
Participant Flow
Participants were enrolled at 44 centers in the US.
All subjects enrolled were included in the trial. All enrolled subjects were randomized at a 1:1:1:1 ratio to receive one of the four vaccine groups.
Participant milestones
| Measure |
Novartis MenACWY Vaccine (11 to 18 Years)
One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
|
Licensed Meningococcal Vaccine (11 to 18 Years)
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
|
Novartis MenACWY Vaccine (19 to 55 Years)
One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
|
Licensed Meningococcal Vaccine (19 to 55 Years)
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1640
|
540
|
1023
|
336
|
|
Overall Study
COMPLETED
|
1594
|
524
|
999
|
325
|
|
Overall Study
NOT COMPLETED
|
46
|
16
|
24
|
11
|
Reasons for withdrawal
| Measure |
Novartis MenACWY Vaccine (11 to 18 Years)
One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
|
Licensed Meningococcal Vaccine (11 to 18 Years)
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
|
Novartis MenACWY Vaccine (19 to 55 Years)
One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
|
Licensed Meningococcal Vaccine (19 to 55 Years)
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
10
|
2
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
31
|
12
|
19
|
9
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
1
|
|
Overall Study
Inappropriate enrollment
|
4
|
1
|
3
|
0
|
|
Overall Study
Administrative reason
|
0
|
0
|
1
|
0
|
|
Overall Study
Unable to Classify
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults
Baseline characteristics by cohort
| Measure |
Novartis MenACWY Vaccine
n=2663 Participants
One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
|
Licensed Meningococcal Vaccine
n=876 Participants
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
|
Total
n=3539 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
11 to 18 years
|
14.2 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
14.1 years
STANDARD_DEVIATION 2.2 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Age, Continuous
19 to 55 years
|
39.0 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
38.7 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
39 years
STANDARD_DEVIATION 38.7 • n=5 Participants
|
|
Sex/Gender, Customized
Female (11 to 18 years)
|
769 participants
n=5 Participants
|
251 participants
n=7 Participants
|
1020 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male (11 to 18 years)
|
871 participants
n=5 Participants
|
289 participants
n=7 Participants
|
1160 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female (19 to 55 years)
|
774 participants
n=5 Participants
|
252 participants
n=7 Participants
|
1026 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male (19 to 55 years)
|
249 participants
n=5 Participants
|
84 participants
n=7 Participants
|
333 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (11 to 18 years)
|
45 participants
n=5 Participants
|
17 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (11 to 18 years)
|
138 participants
n=5 Participants
|
45 participants
n=7 Participants
|
183 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian (11 to 18 years)
|
1280 participants
n=5 Participants
|
423 participants
n=7 Participants
|
1703 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (11 to 18 years)
|
126 participants
n=5 Participants
|
34 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (11 to 18 years)
|
51 participants
n=5 Participants
|
21 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (19 to 55 years)
|
37 participants
n=5 Participants
|
8 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black (19 to 55 years)
|
85 participants
n=5 Participants
|
34 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian (19 to 55 years)
|
828 participants
n=5 Participants
|
261 participants
n=7 Participants
|
1089 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic (19 to 55 years)
|
60 participants
n=5 Participants
|
29 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other (19 to 55 years)
|
13 participants
n=5 Participants
|
4 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after vaccinationPopulation: The analysis was performed on the Per Protocol (PP) Population
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=359 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=357 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
n=359 Participants
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Serogroup A
|
29 Titers
Interval 23.0 to 38.0
|
33 Titers
Interval 25.0 to 42.0
|
31 Titers
Interval 24.0 to 40.0
|
|
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Serogroup C (N=499, 493, 491)
|
77 Titers
Interval 58.0 to 102.0
|
58 Titers
Interval 43.0 to 77.0
|
64 Titers
Interval 48.0 to 86.0
|
|
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Serogroup W (N=340, 341, 343)
|
87 Titers
Interval 70.0 to 108.0
|
111 Titers
Interval 89.0 to 138.0
|
82 Titers
Interval 66.0 to 102.0
|
|
Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Serogroup Y (N=345, 345, 346)
|
48 Titers
Interval 37.0 to 62.0
|
61 Titers
Interval 47.0 to 79.0
|
53 Titers
Interval 41.0 to 69.0
|
PRIMARY outcome
Timeframe: 28 days after vaccinationPopulation: The analysis set was the per protocol (PP) population.
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=1075 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=359 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Percentage of Seroresponders, Ages 11 to 18 Years
Serogroup A
|
75 Percentage of participants
Interval 72.0 to 77.0
|
66 Percentage of participants
Interval 61.0 to 71.0
|
—
|
|
Percentage of Seroresponders, Ages 11 to 18 Years
Serogroup C (N= 1483, 501)
|
75 Percentage of participants
Interval 73.0 to 77.0
|
73 Percentage of participants
Interval 69.0 to 77.0
|
—
|
|
Percentage of Seroresponders, Ages 11 to 18 Years
Serogroup W (N= 1024, 288)
|
75 Percentage of participants
Interval 72.0 to 77.0
|
63 Percentage of participants
Interval 57.0 to 68.0
|
—
|
|
Percentage of Seroresponders, Ages 11 to 18 Years
Serogroup Y (N= 1036, 294)
|
68 Percentage of participants
Interval 65.0 to 71.0
|
41 Percentage of participants
Interval 35.0 to 47.0
|
—
|
PRIMARY outcome
Timeframe: 6 days after vaccinationPopulation: The analysis was performed on the safety set.
Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=2649 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=875 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
|
94 Participants
|
24 Participants
|
—
|
PRIMARY outcome
Timeframe: 28 days after vaccinationPopulation: The analysis set was the per protocol (PP) population.
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=963 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=321 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Percentage of Seroresponders, Ages 19 to 55 Years
Serogroup A
|
67 Percentage of participants
Interval 64.0 to 70.0
|
68 Percentage of participants
Interval 63.0 to 73.0
|
—
|
|
Percentage of Seroresponders, Ages 19 to 55 Years
Serogroup C (N=961, 318)
|
67 Percentage of participants
Interval 64.0 to 70.0
|
58 Percentage of participants
Interval 53.0 to 64.0
|
—
|
|
Percentage of Seroresponders, Ages 19 to 55 Years
Serogroup W (N= 484, 292)
|
50 Percentage of participants
Interval 46.0 to 55.0
|
41 Percentage of participants
Interval 35.0 to 47.0
|
—
|
|
Percentage of Seroresponders, Ages 19 to 55 Years
Serogroup Y (N= 503, 306)
|
56 Percentage of participants
Interval 51.0 to 60.0
|
40 Percentage of participants
Interval 34.0 to 46.0
|
—
|
SECONDARY outcome
Timeframe: 28 days after vaccinationPopulation: The Analysis set was the per protocol (PP) population.
The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=359 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=357 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
n=359 Participants
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Seroresponse in serogroup A
|
71 Percentage of Participants
Interval 66.0 to 76.0
|
75 Percentage of Participants
Interval 70.0 to 79.0
|
77 Percentage of Participants
Interval 73.0 to 82.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Seroresponse in serogroup C (N= 499, 493, 491)
|
78 Percentage of Participants
Interval 74.0 to 82.0
|
73 Percentage of Participants
Interval 69.0 to 77.0
|
74 Percentage of Participants
Interval 70.0 to 78.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Seroresponse in serogroup W (N= 340, 341, 343)
|
74 Percentage of Participants
Interval 69.0 to 78.0
|
80 Percentage of Participants
Interval 75.0 to 84.0
|
70 Percentage of Participants
Interval 65.0 to 75.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Seroresponse in serogroup Y (N= 345, 345, 346)
|
66 Percentage of Participants
Interval 61.0 to 71.0
|
72 Percentage of Participants
Interval 67.0 to 77.0
|
65 Percentage of Participants
Interval 60.0 to 70.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:8 in serogroup A
|
72 Percentage of Participants
Interval 67.0 to 77.0
|
76 Percentage of Participants
Interval 71.0 to 80.0
|
78 Percentage of Participants
Interval 74.0 to 82.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:8 in serogroup C (N= 499, 493, 491)
|
86 Percentage of Participants
Interval 82.0 to 89.0
|
84 Percentage of Participants
Interval 81.0 to 87.0
|
83 Percentage of Participants
Interval 79.0 to 86.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:8 in serogroup W (N= 340, 341, 343)
|
95 Percentage of Participants
Interval 92.0 to 97.0
|
97 Percentage of Participants
Interval 95.0 to 99.0
|
96 Percentage of Participants
Interval 93.0 to 98.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:8 in serogroup Y (N= 345, 345, 346)
|
86 Percentage of Participants
Interval 82.0 to 89.0
|
89 Percentage of Participants
Interval 85.0 to 92.0
|
88 Percentage of Participants
Interval 85.0 to 92.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:4 in serogroup A
|
76 Percentage of Participants
Interval 72.0 to 81.0
|
79 Percentage of Participants
Interval 74.0 to 83.0
|
81 Percentage of Participants
Interval 77.0 to 85.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:4 in serogroup C (N= 499, 493, 491)
|
89 Percentage of Participants
Interval 86.0 to 91.0
|
88 Percentage of Participants
Interval 85.0 to 91.0
|
88 Percentage of Participants
Interval 85.0 to 91.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:4 in serogroup W (N= 340, 341, 343)
|
95 Percentage of Participants
Interval 92.0 to 97.0
|
97 Percentage of Participants
Interval 95.0 to 99.0
|
97 Percentage of Participants
Interval 94.0 to 98.0
|
|
Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
hSBA Titer ≥ 1:4 in serogroup Y (N= 345, 345, 346
|
89 Percentage of Participants
Interval 85.0 to 92.0
|
92 Percentage of Participants
Interval 89.0 to 95.0
|
93 Percentage of Participants
Interval 90.0 to 96.0
|
SECONDARY outcome
Timeframe: 28 days after vaccinationPopulation: The analyses set was performed on the per protocol (PP) population.
Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age). Seroresponse to MenACWY: For a subject with hSBA titer \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=2038 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=680 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Seroresponse in serogroup A
|
71 Percentage of participants
Interval 69.0 to 73.0
|
67 Percentage of participants
Interval 63.0 to 71.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Seroresponse in serogroup C (N= 2444, 819)
|
72 Percentage of participants
Interval 70.0 to 74.0
|
67 Percentage of participants
Interval 64.0 to 70.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Seroresponse in serogroup W (N= 1508, 580)
|
67 Percentage of participants
Interval 64.0 to 69.0
|
52 Percentage of participants
Interval 47.0 to 56.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Seroresponse in serogroup Y (N= 1539, 600)
|
64 Percentage of participants
Interval 61.0 to 66.0
|
41 Percentage of participants
Interval 37.0 to 45.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:8 in serogroup A
|
72 Percentage of participants
Interval 70.0 to 74.0
|
69 Percentage of participants
Interval 65.0 to 72.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:8 in serogroup C (N= 2444, 819)
|
83 Percentage of participants
Interval 81.0 to 84.0
|
79 Percentage of participants
Interval 76.0 to 82.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:8 in serogroup W (N= 1508, 580)
|
95 Percentage of participants
Interval 94.0 to 96.0
|
89 Percentage of participants
Interval 86.0 to 91.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:8 in serogroup Y (N= 1539, 600)
|
85 Percentage of participants
Interval 83.0 to 87.0
|
70 Percentage of participants
Interval 66.0 to 73.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:4 in serogroup A
|
75 Percentage of participants
Interval 74.0 to 77.0
|
73 Percentage of participants
Interval 69.0 to 76.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:4 in serogroup C (N= 2444, 819)
|
87 Percentage of participants
Interval 86.0 to 88.0
|
85 Percentage of participants
Interval 83.0 to 88.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:4 in serogroup W (N= 1508, 580)
|
96 Percentage of participants
Interval 95.0 to 97.0
|
91 Percentage of participants
Interval 88.0 to 93.0
|
—
|
|
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
hSBA≥1:4 in serogroup Y (N= 1539, 600)
|
90 Percentage of participants
Interval 88.0 to 91.0
|
77 Percentage of participants
Interval 74.0 to 81.0
|
—
|
SECONDARY outcome
Timeframe: 28 days after vaccinationPopulation: The analysis set was the per protocol (PP) population.
Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=2038 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=680 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Titers in serogroup A
|
29 Titers
Interval 26.0 to 32.0
|
22 Titers
Interval 19.0 to 26.0
|
—
|
|
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Titers in serogroup C (N= 2444, 819)
|
55 Titers
Interval 49.0 to 62.0
|
39 Titers
Interval 33.0 to 47.0
|
—
|
|
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Titers in serogroup W (N= 1508, 580)
|
100 Titers
Interval 90.0 to 112.0
|
57 Titers
Interval 49.0 to 66.0
|
—
|
|
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Titers in serogroup Y (N= 1539 600)
|
53 Titers
Interval 47.0 to 60.0
|
21 Titers
Interval 18.0 to 25.0
|
—
|
SECONDARY outcome
Timeframe: Days 1 to 7Population: The analysis was performed on the safety set.
Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).
Outcome measures
| Measure |
Novartis MenACWY Lot 1
n=2649 Participants
One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 2
n=875 Participants
One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
|
Novartis MenACWY Lot 3
One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Arthralgia
|
197 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Pain
|
1105 Participants
|
424 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Erythema
|
414 Participants
|
126 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Induration
|
324 Participants
|
88 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Chills
|
168 Participants
|
50 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Nausea
|
260 Participants
|
65 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Malaise
|
279 Participants
|
99 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Myalgia
|
452 Participants
|
149 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Headache
|
731 Participants
|
237 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Rash
|
69 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Fever ≥38°C
|
32 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Any Other Reaction
|
555 Participants
|
183 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Analgesic/Antipyretic Medication Used
|
533 Participants
|
178 Participants
|
—
|
|
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Stayed Home
|
69 Participants
|
17 Participants
|
—
|
Adverse Events
Novartis MenACWY Vaccine
Serious events: 23 serious events
Other events: 1613 other events
Deaths: 0 deaths
Licensed Meningococcal Vaccine
Serious events: 5 serious events
Other events: 572 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Novartis MenACWY Vaccine
n=2649 participants at risk
One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
|
Licensed Meningococcal Vaccine
n=875 participants at risk
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Vitello-Intestinal Duct Remnant
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
General disorders
Chest Pain
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Infections and infestations
Appendicitis
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Infections and infestations
Meningitis Viral
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Infections and infestations
Pneumonia
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Infections and infestations
Staphylococcal Infection
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Infections and infestations
Tonsillitis
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Dislocation of Sternum
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.04%
1/2649 • Number of events 2 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Ligament Rupture
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.11%
3/2649 • Number of events 3 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Injury, poisoning and procedural complications
Craniocerebral Injury
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Epishysiolysis
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Dystonia
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Epilepsy
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Myoclonic Epilepsy
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Simple Partial Seizures
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Psychiatric disorders
Depression Suicidal
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Psychiatric disorders
Suicide Attempt
|
0.08%
2/2649 • Number of events 2 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.04%
1/2649 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.00%
0/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
0.11%
1/875 • Number of events 1 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
Other adverse events
| Measure |
Novartis MenACWY Vaccine
n=2649 participants at risk
One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
|
Licensed Meningococcal Vaccine
n=875 participants at risk
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
|
|---|---|---|
|
General disorders
Injection site pain
|
41.8%
1106/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
48.5%
424/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
General disorders
Injection site erythema
|
15.6%
414/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
14.4%
126/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
General disorders
Injection site induration
|
12.2%
324/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
10.1%
88/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
General disorders
Chills
|
6.4%
169/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
5.7%
50/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
265/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
7.5%
66/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
General disorders
Malaise
|
10.6%
280/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
11.4%
100/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.1%
453/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
17.1%
150/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.0%
211/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
6.7%
59/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
|
Nervous system disorders
Headache
|
27.9%
740/2649 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
27.4%
240/875 • Serious adverse events were collected from study day 1 to 180.
A total of 3539 subjects were enrolled in the study; 3524 were vaccinated to receive MenACWY (2649 subjects) or Menactra (875). ). Overall, 15 subjects were not vaccinated and were excluded from the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place