Trial Outcomes & Findings for Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine (NCT NCT01148017)
NCT ID: NCT01148017
Last Updated: 2017-08-14
Results Overview
The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
433 participants
Primary outcome timeframe
Visit 9 (continuation from the parent study), 40-month visit.
Results posted on
2017-08-14
Participant Flow
Participant milestones
| Measure |
ACWY - 4
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
214
|
121
|
53
|
45
|
|
Overall Study
COMPLETED
|
134
|
87
|
53
|
45
|
|
Overall Study
NOT COMPLETED
|
80
|
34
|
0
|
0
|
Reasons for withdrawal
| Measure |
ACWY - 4
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
31
|
14
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
23
|
10
|
0
|
0
|
|
Overall Study
Inappropriate enrollment
|
1
|
0
|
0
|
0
|
|
Overall Study
Administrative reason
|
22
|
9
|
0
|
0
|
|
Overall Study
Unable to classify
|
3
|
1
|
0
|
0
|
Baseline Characteristics
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Baseline characteristics by cohort
| Measure |
ACWY - 4
n=214 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=121 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=53 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
n=45 Participants
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
Total
n=433 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
40 months enrollment (N=210, 119, 53, 382)
|
39.2 Months
STANDARD_DEVIATION 1.8 • n=5 Participants
|
39.3 Months
STANDARD_DEVIATION 1.7 • n=7 Participants
|
38.7 Months
STANDARD_DEVIATION 1.8 • n=5 Participants
|
NA Months
STANDARD_DEVIATION NA • n=4 Participants
|
39.2 Months
STANDARD_DEVIATION 1.8 • n=21 Participants
|
|
Age, Continuous
60 months enrollment (N=136, 89, 45, 270)
|
59.7 Months
STANDARD_DEVIATION 2.2 • n=5 Participants
|
59.6 Months
STANDARD_DEVIATION 2.4 • n=7 Participants
|
NA Months
STANDARD_DEVIATION NA • n=5 Participants
|
60 Months
STANDARD_DEVIATION 1.7 • n=4 Participants
|
59.7 Months
STANDARD_DEVIATION 2.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
207 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
226 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
214 participants
n=5 Participants
|
121 participants
n=7 Participants
|
53 participants
n=5 Participants
|
45 participants
n=4 Participants
|
433 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Visit 9 (continuation from the parent study), 40-month visit.Population: Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.
The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
ACWY - 4
n=206 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=117 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=51 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men A
|
10 Percentages of subjects
Interval 6.0 to 15.0
|
35 Percentages of subjects
Interval 26.0 to 44.0
|
2 Percentages of subjects
Interval 0.05 to 10.0
|
—
|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men C (N=206, 116, 51)
|
34 Percentages of subjects
Interval 28.0 to 41.0
|
51 Percentages of subjects
Interval 41.0 to 60.0
|
12 Percentages of subjects
Interval 4.0 to 24.0
|
—
|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men W-135 (N=204, 115, 51)
|
76 Percentages of subjects
Interval 70.0 to 82.0
|
83 Percentages of subjects
Interval 74.0 to 89.0
|
47 Percentages of subjects
Interval 33.0 to 62.0
|
—
|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men Y (N=205, 116, 51)
|
67 Percentages of subjects
Interval 60.0 to 73.0
|
71 Percentages of subjects
Interval 62.0 to 79.0
|
22 Percentages of subjects
Interval 11.0 to 35.0
|
—
|
PRIMARY outcome
Timeframe: Visit 10, 60 months of agePopulation: Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.
The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
ACWY - 4
n=123 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=80 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=45 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men A
|
6 Percentages of subjects
Interval 2.0 to 11.0
|
25 Percentages of subjects
Interval 16.0 to 36.0
|
2 Percentages of subjects
Interval 0.056 to 12.0
|
—
|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men C
|
27 Percentages of subjects
Interval 19.0 to 36.0
|
43 Percentages of subjects
Interval 32.0 to 54.0
|
22 Percentages of subjects
Interval 11.0 to 37.0
|
—
|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men W-135 (N=121, 78, 45)
|
69 Percentages of subjects
Interval 60.0 to 77.0
|
74 Percentages of subjects
Interval 63.0 to 84.0
|
40 Percentages of subjects
Interval 26.0 to 56.0
|
—
|
|
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Men Y (N=122, 80, 44)
|
56 Percentages of subjects
Interval 46.0 to 65.0
|
69 Percentages of subjects
Interval 57.0 to 79.0
|
25 Percentages of subjects
Interval 13.0 to 40.0
|
—
|
SECONDARY outcome
Timeframe: Visit 9, 40 months of age.Population: Analysis was done on the PPS 40-month persistence.
The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
ACWY - 4
n=206 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=117 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=51 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men A
|
13 Percentages of subjects
Interval 9.0 to 18.0
|
40 Percentages of subjects
Interval 31.0 to 50.0
|
2 Percentages of subjects
Interval 0.05 to 10.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men C (N=206, 116, 51)
|
43 Percentages of subjects
Interval 36.0 to 50.0
|
61 Percentages of subjects
Interval 52.0 to 70.0
|
16 Percentages of subjects
Interval 7.0 to 29.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men W-135 (N=204, 115, 51)
|
81 Percentages of subjects
Interval 75.0 to 86.0
|
88 Percentages of subjects
Interval 80.0 to 93.0
|
49 Percentages of subjects
Interval 35.0 to 63.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men Y (N=205, 116, 51)
|
76 Percentages of subjects
Interval 69.0 to 81.0
|
80 Percentages of subjects
Interval 72.0 to 87.0
|
24 Percentages of subjects
Interval 13.0 to 37.0
|
—
|
SECONDARY outcome
Timeframe: Visit 10, 60 months of age.Population: Analysis was done on the PPS 60-Month persistence.
The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
ACWY - 4
n=123 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=80 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=45 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Men A
|
9 Percentages of subjects
Interval 5.0 to 15.0
|
33 Percentages of subjects
Interval 22.0 to 44.0
|
2 Percentages of subjects
Interval 0.056 to 12.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Men C
|
46 Percentages of subjects
Interval 37.0 to 55.0
|
60 Percentages of subjects
Interval 48.0 to 71.0
|
33 Percentages of subjects
Interval 20.0 to 49.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Men W-135 (N=121, 78, 45)
|
74 Percentages of subjects
Interval 66.0 to 82.0
|
83 Percentages of subjects
Interval 73.0 to 91.0
|
42 Percentages of subjects
Interval 28.0 to 58.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Men Y (N=122, 80, 44)
|
65 Percentages of subjects
Interval 56.0 to 73.0
|
74 Percentages of subjects
Interval 63.0 to 83.0
|
25 Percentages of subjects
Interval 13.0 to 40.0
|
—
|
SECONDARY outcome
Timeframe: Visit 9 (continuation from the parent study), 40-months of age.Population: Analysis was done on the PPS 40-month persistence.
The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
ACWY - 4
n=206 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=117 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=51 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men A
|
2.54 Titers
Interval 2.23 to 2.9
|
4.81 Titers
Interval 4.06 to 5.69
|
2.02 Titers
Interval 1.57 to 2.61
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men C (N=206, 116, 51)
|
6.14 Titers
Interval 4.98 to 7.59
|
9.24 Titers
Interval 7.05 to 12.0
|
2.52 Titers
Interval 1.68 to 3.78
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men W-135 (N=204, 115, 51)
|
26 Titers
Interval 21.0 to 32.0
|
29 Titers
Interval 22.0 to 39.0
|
8.25 Titers
Interval 5.47 to 12.0
|
—
|
|
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Men Y (N=205, 116, 51)
|
16 Titers
Interval 13.0 to 20.0
|
18 Titers
Interval 14.0 to 24.0
|
3.69 Titers
Interval 2.44 to 5.57
|
—
|
SECONDARY outcome
Timeframe: Visit 10, 60 months of age.Population: Analysis was done on the PPS 60-Month persistence.
The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Outcome measures
| Measure |
ACWY - 4
n=123 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=80 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=45 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Men A
|
2.27 Titers
Interval 1.95 to 2.63
|
3.74 Titers
Interval 3.12 to 4.48
|
2.14 Titers
Interval 1.68 to 2.74
|
—
|
|
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Men C
|
5.17 Titers
Interval 3.96 to 6.75
|
9.26 Titers
Interval 6.71 to 13.0
|
3.87 Titers
Interval 2.5 to 5.98
|
—
|
|
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Men W-135 (N=121, 78, 45)
|
17 Titers
Interval 13.0 to 22.0
|
20 Titers
Interval 14.0 to 28.0
|
6.63 Titers
Interval 4.25 to 10.0
|
—
|
|
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Men Y (N=122, 80, 44)
|
11 Titers
Interval 8.1 to 14.0
|
14 Titers
Interval 9.94 to 19.0
|
4.1 Titers
Interval 2.61 to 6.45
|
—
|
SECONDARY outcome
Timeframe: Visit 11, 1 month after vaccination.Population: Analysis was done on the PPS-Immunogenicity after one dose of MenACWY-CRM (PPS Post-MenACWY-CRM), ie, all subjects in the enrolled population who correctly received the vaccine, provided at least one evaluable serum sample at the relevant time points and whose assay result was available for at least one serogroup with no major protocol deviation.
The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.
Outcome measures
| Measure |
ACWY - 4
n=116 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=76 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=45 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men A (≥1:8)
|
97 Percentages of subjects
Interval 91.0 to 99.0
|
97 Percentages of subjects
Interval 91.0 to 100.0
|
87 Percentages of subjects
Interval 73.0 to 95.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men C (≥1:8; N=115, 75, 45)
|
96 Percentages of subjects
Interval 90.0 to 99.0
|
99 Percentages of subjects
Interval 93.0 to 100.0
|
84 Percentages of subjects
Interval 71.0 to 94.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men W-135 (≥1:8; N=104, 70, 44)
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
100 Percentages of subjects
Interval 95.0 to 100.0
|
89 Percentages of subjects
Interval 75.0 to 96.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men Y (≥1:8; N=111, 74, 44)
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
100 Percentages of subjects
Interval 95.0 to 100.0
|
73 Percentages of subjects
Interval 57.0 to 85.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men A (≥1:4)
|
97 Percentages of subjects
Interval 91.0 to 99.0
|
97 Percentages of subjects
Interval 91.0 to 100.0
|
89 Percentages of subjects
Interval 76.0 to 96.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men C (≥1:4; N=115, 75, 45)
|
97 Percentages of subjects
Interval 93.0 to 99.0
|
100 Percentages of subjects
Interval 95.0 to 100.0
|
87 Percentages of subjects
Interval 73.0 to 95.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men W-135 (≥1:4; N=104, 70, 44)
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
100 Percentages of subjects
Interval 95.0 to 100.0
|
91 Percentages of subjects
Interval 78.0 to 97.0
|
—
|
|
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Men Y (≥1:4; N=111, 74, 44)
|
100 Percentages of subjects
Interval 97.0 to 100.0
|
100 Percentages of subjects
Interval 95.0 to 100.0
|
80 Percentages of subjects
Interval 65.0 to 90.0
|
—
|
SECONDARY outcome
Timeframe: Visit 11, 1 month after vaccination.Population: Analysis was done on the PPS Post-MenACWY-CRM.
The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination. Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4.
Outcome measures
| Measure |
ACWY - 4
n=116 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=76 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=45 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Men A
|
97 Percentage of subjects
Interval 91.0 to 99.0
|
96 Percentage of subjects
Interval 89.0 to 99.0
|
87 Percentage of subjects
Interval 73.0 to 95.0
|
—
|
|
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Men C (N=115, 75, 45)
|
87 Percentage of subjects
Interval 79.0 to 93.0
|
87 Percentage of subjects
Interval 77.0 to 93.0
|
73 Percentage of subjects
Interval 58.0 to 85.0
|
—
|
|
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Men W-135 (N=104, 70, 44)
|
99 Percentage of subjects
Interval 95.0 to 100.0
|
100 Percentage of subjects
Interval 95.0 to 100.0
|
57 Percentage of subjects
Interval 41.0 to 72.0
|
—
|
|
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Men Y (N=111, 74, 44)
|
98 Percentage of subjects
Interval 94.0 to 100.0
|
99 Percentage of subjects
Interval 93.0 to 100.0
|
52 Percentage of subjects
Interval 37.0 to 68.0
|
—
|
SECONDARY outcome
Timeframe: From day 1 to 7 after vaccination.Population: Analysis was done on the Solicited Safety Set (from 6 hours to day 7), ie, all subjects who received a vaccination at 60 months and provided postvaccination solicited safety data.
Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination. Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs.
Outcome measures
| Measure |
ACWY - 4
n=129 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=83 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=49 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Fever
|
4 Subjects
|
2 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Any other
|
18 Subjects
|
11 Subjects
|
7 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Irritability
|
24 Subjects
|
14 Subjects
|
8 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Any local
|
67 Subjects
|
44 Subjects
|
29 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Injection site pain
|
54 Subjects
|
33 Subjects
|
24 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Injection site erythema
|
26 Subjects
|
20 Subjects
|
13 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Injection site induration
|
18 Subjects
|
14 Subjects
|
10 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Any systemic
|
45 Subjects
|
26 Subjects
|
23 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Change in eating habits
|
14 Subjects
|
5 Subjects
|
4 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Sleepiness
|
20 Subjects
|
9 Subjects
|
7 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Vomiting
|
4 Subjects
|
0 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Diarrhea
|
7 Subjects
|
1 Subjects
|
1 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Arthralgia
|
2 Subjects
|
4 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Headache
|
6 Subjects
|
6 Subjects
|
2 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Rash
|
4 Subjects
|
2 Subjects
|
3 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Stayed home due to reaction
|
5 Subjects
|
0 Subjects
|
0 Subjects
|
—
|
|
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Use of analgesics/antipyretics
|
18 Subjects
|
11 Subjects
|
7 Subjects
|
—
|
SECONDARY outcome
Timeframe: Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).Population: Analysis was done on the Post MenACWY at 60 months safety set ie, all subjects who received a vaccination at 60 months and were assessed for postvaccination safety, and on the Post MenACWY at 40 Months Safety Set, ie, the Naive subjects enrolled at 40 months of age who received vaccination at 40 months and were assessed for post vaccination safety.
Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.
Outcome measures
| Measure |
ACWY - 4
n=132 Participants
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=87 Participants
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=11 Participants
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
n=50 Participants
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Number of Subjects Reporting Unsolicited AEs and SAEs
Any unsolicited AE
|
7 Number of subjects
|
8 Number of subjects
|
NA Number of subjects
Unsolicited AEs were not recorded for this group.
|
12 Number of subjects
|
|
Number of Subjects Reporting Unsolicited AEs and SAEs
Medically attended AEs
|
0 Number of subjects
|
0 Number of subjects
|
27 Number of subjects
|
0 Number of subjects
|
|
Number of Subjects Reporting Unsolicited AEs and SAEs
Any SAE
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
0 Number of subjects
|
Adverse Events
ACWY - 4
Serious events: 0 serious events
Other events: 86 other events
Deaths: 0 deaths
ACWY - 2
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Naïve - 40
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Naïve - 60
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACWY - 4
n=132 participants at risk
Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
ACWY - 2
n=87 participants at risk
Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
|
Naïve - 40
n=11 participants at risk
Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
|
Naïve - 60
n=50 participants at risk
Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
1.1%
1/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
8.0%
4/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
7/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
2.3%
2/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
2.0%
1/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
4/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
6.0%
3/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
General disorders
Injection site erythema
|
19.7%
26/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
25.3%
22/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
26.0%
13/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
General disorders
Injection site induration
|
15.9%
21/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
17.2%
15/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
22.0%
11/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
General disorders
Injection site pain
|
44.7%
59/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
42.5%
37/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
48.0%
24/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
General disorders
Irritability
|
18.2%
24/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
16.1%
14/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
18.0%
9/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Infections and infestations
Otitis media acute
|
0.76%
1/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
9.1%
1/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
9.1%
1/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
4.0%
2/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
9.1%
1/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
2/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
4.6%
4/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
9.1%
1/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
2.0%
1/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Nervous system disorders
Headache
|
4.5%
6/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
8.0%
7/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
4.0%
2/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Nervous system disorders
Somnolence
|
15.9%
21/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
10.3%
9/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
14.0%
7/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Psychiatric disorders
Eating disorders
|
10.6%
14/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
5.7%
5/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
8.0%
4/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Skin and subcutaneous tissue disorders
Ingrown nail
|
0.00%
0/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
9.1%
1/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
4/132 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
2.3%
2/87 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
0.00%
0/11 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
6.0%
3/50 • Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.
Analysis for the solicited and unsolicited non-serious AEs was done on the Overall Post MenACWY Safety Set, ie, all subjects who received a vaccination at 40 or 60 months and were assessed for postvaccination safety. Analysis for serious adverse events was done on the Post MenACWY at 60 Months and at 40 Months Safety Sets.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place