Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months (NCT NCT01000311)
NCT ID: NCT01000311
Last Updated: 2014-04-21
Results Overview
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
529 participants
Primary outcome timeframe
Baseline and one month after fourth-dose of MenACWY-CRM
Results posted on
2014-04-21
Participant Flow
Subjects were enrolled at 42 study sites in the United States, 3 sites in Australia and 1 site in Canada.
All enrolled subjects were included in the study.
Participant milestones
| Measure |
MenACWY-CRM + Routine Vaccines
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
258
|
271
|
|
Overall Study
COMPLETED
|
213
|
201
|
|
Overall Study
NOT COMPLETED
|
45
|
70
|
Reasons for withdrawal
| Measure |
MenACWY-CRM + Routine Vaccines
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
5
|
|
Overall Study
Withdrawal by Subject
|
16
|
24
|
|
Overall Study
Lost to Follow-up
|
15
|
24
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Inappropriate enrollment
|
2
|
0
|
|
Overall Study
Administrative reason
|
9
|
15
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Baseline characteristics by cohort
| Measure |
MenACWY-CRM + Routine Vaccines
n=258 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=271 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.7 Days
STANDARD_DEVIATION 6.5 • n=5 Participants
|
65.4 Days
STANDARD_DEVIATION 7.4 • n=7 Participants
|
65.1 Days
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
274 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and one month after fourth-dose of MenACWY-CRMPopulation: Analysis was done on the per-protocol (PP) toddler dataset for MenACWY-CRM, i.e. the subjects who received all the relevant doses of vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to database lock.
Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=170 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=178 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup A - Baseline (N=170,178)
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
1 Percentage of subjects
Interval 0.014 to 3.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup C - Post-4th dose (N=156,171)
|
95 Percentage of subjects
Interval 90.0 to 98.0
|
2 Percentage of subjects
Interval 1.0 to 6.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup W - Baseline (N=152,164)
|
13 Percentage of subjects
Interval 8.0 to 20.0
|
15 Percentage of subjects
Interval 10.0 to 21.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup W - Post-4th dose (N=153,165)
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
7 Percentage of subjects
Interval 3.0 to 12.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup Y - Post-4th dose (N=153,159)
|
96 Percentage of subjects
Interval 92.0 to 99.0
|
1 Percentage of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup A - Post-4th dose (N=168,175)
|
89 Percentage of subjects
Interval 83.0 to 93.0
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup C - Baseline (N=166,174)
|
7 Percentage of subjects
Interval 3.0 to 12.0
|
7 Percentage of subjects
Interval 4.0 to 12.0
|
|
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup Y - Baseline (N=144,150)
|
8 Percentage of subjects
Interval 4.0 to 13.0
|
4 Percentage of subjects
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline and one month after fourth-dose of MenACWY-CRMPopulation: Analysis was performed on the PP toddler dataset for MenACWY-CRM vaccination.
Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=168 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=175 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup Y - Post-4th dose (N=153,159)
|
185 Titers
Interval 148.0 to 233.0
|
1.89 Titers
Interval 1.56 to 2.29
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup A - Baseline (N=139,145)
|
2.07 Titers
Interval 1.98 to 2.16
|
2.01 Titers
Interval 1.99 to 2.03
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup A - Post-4th dose (N=168,175)
|
54 Titers
Interval 44.0 to 67.0
|
1.87 Titers
Interval 1.55 to 2.27
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup C - Baseline (N=126,136)
|
2.49 Titers
Interval 2.2 to 2.83
|
2.44 Titers
Interval 2.2 to 2.7
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup C - Post-4th dose (N=156,171)
|
135 Titers
Interval 107.0 to 171.0
|
1.94 Titers
Interval 1.56 to 2.4
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup W - Baseline (N=113,126)
|
2.99 Titers
Interval 2.49 to 3.6
|
2.97 Titers
Interval 2.52 to 3.51
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup W - Post-4th dose (N=153,165)
|
215 Titers
Interval 167.0 to 277.0
|
2.15 Titers
Interval 1.77 to 2.6
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup Y - Baseline (N=108,113)
|
2.43 Titers
Interval 2.19 to 2.71
|
2.32 Titers
Interval 2.13 to 2.52
|
SECONDARY outcome
Timeframe: Baseline and one month after third infant dose of MenACWY-CRMPopulation: Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age. Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=202 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=208 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup C - hSBA ≥1:8 -Post-3rd dose(N=199,206)
|
94 Percentage of subjects
Interval 90.0 to 97.0
|
1 Percentage of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup W - hSBA ≥1:8 -Baseline(N=152,164)
|
13 Percentage of subjects
Interval 8.0 to 20.0
|
15 Percentage of subjects
Interval 10.0 to 21.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup Y - hSBA ≥1:8 -Post-3rd dose(N=188,196)
|
94 Percentage of subjects
Interval 89.0 to 97.0
|
3 Percentage of subjects
Interval 1.0 to 6.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup A - 4-fold rise-Post-3rd dose(N=170,177)
|
78 Percentage of subjects
Interval 71.0 to 84.0
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup A - hSBA ≥1:8-Baseline (N=170,178)
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
1 Percentage of subjects
Interval 0.014 to 3.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup A - hSBA ≥1:8 -Post-3rd dose(N=202,208)
|
76 Percentage of subjects
Interval 69.0 to 81.0
|
1 Percentage of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup C - hSBA ≥1:8 -Baseline(N=166,174)
|
7 Percentage of subjects
Interval 3.0 to 12.0
|
7 Percentage of subjects
Interval 4.0 to 12.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup W - hSBA ≥1:8 -Post-3rd dose(N=194,202)
|
98 Percentage of subjects
Interval 95.0 to 99.0
|
3 Percentage of subjects
Interval 1.0 to 7.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup Y - hSBA ≥1:8 -Baseline(N=144,150)
|
8 Percentage of subjects
Interval 4.0 to 13.0
|
4 Percentage of subjects
Interval 1.0 to 9.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup C - 4-fold rise-Post-3rd dose(N=164,171)
|
94 Percentage of subjects
Interval 89.0 to 97.0
|
1 Percentage of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup W - 4-fold rise-Post-3rd dose(N=147,158)
|
93 Percentage of subjects
Interval 87.0 to 96.0
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
|
Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup Y -4-fold rise-Post-3rd dose(N=135,142)
|
93 Percentage of subjects
Interval 87.0 to 96.0
|
2 Percentage of subjects
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: Baseline and one month after third infant dose of MenACWY-CRMPopulation: Analysis was performed on the PP dataset of MenACWY-CRM infant vaccination series.
Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=202 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=209 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup C - Post-3rd dose (N=199,206)
|
74 Titers
Interval 62.0 to 87.0
|
1.94 Titers
Interval 1.64 to 2.3
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup A - Baseline (N=170,178)
|
2.09 Titers
Interval 2.0 to 2.18
|
2.05 Titers
Interval 1.98 to 2.12
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup A - Post-3rd dose (N=202,208)
|
21 Titers
Interval 17.0 to 26.0
|
2.08 Titers
Interval 1.99 to 2.17
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup C - Baseline (N=166,174)
|
2.49 Titers
Interval 2.25 to 2.76
|
2.39 Titers
Interval 2.18 to 2.61
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup W - Baseline (N=152,164)
|
2.94 Titers
Interval 2.52 to 3.43
|
2.98 Titers
Interval 2.58 to 3.45
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup W - Post-3rd dose (N=194,202)
|
79 Titers
Interval 67.0 to 92.0
|
1.94 Titers
Interval 1.68 to 2.24
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup Y - Baseline (N=144,150)
|
2.52 Titers
Interval 2.28 to 2.77
|
2.26 Titers
Interval 2.12 to 2.41
|
|
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
Serogroup Y - Post-3rd dose (N=188,196)
|
51 Titers
Interval 43.0 to 61.0
|
2.13 Titers
Interval 2.02 to 2.25
|
SECONDARY outcome
Timeframe: One month after third dose of routine infant series vaccinationPopulation: Analysis was performed on the PP concomitant, pertussis and hepatitis B infant populations.
The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age. The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=207 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=218 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PT (N=185,191)
|
77 Percentage of subjects
Interval 71.0 to 83.0
|
81 Percentage of subjects
Interval 75.0 to 86.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 18C - ≥0.35 μg/mL (N=183,178)
|
95 Percentage of subjects
Interval 90.0 to 97.0
|
97 Percentage of subjects
Interval 94.0 to 99.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Diphtheria (≥0.1 IU/mL) (N=207,218)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Tetanus (≥0.1 IU/mL) (N=207,218)
|
97 Percentage of subjects
Interval 94.0 to 99.0
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
FHA (N=185,191)
|
70 Percentage of subjects
Interval 63.0 to 76.0
|
65 Percentage of subjects
Interval 58.0 to 72.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Pertactin (N=185,191)
|
73 Percentage of subjects
Interval 66.0 to 79.0
|
73 Percentage of subjects
Interval 66.0 to 79.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
FIM (N=185,191)
|
74 Percentage of subjects
Interval 67.0 to 80.0
|
76 Percentage of subjects
Interval 69.0 to 82.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Polio Type 1 - ≥1:8 (N=115,113)
|
99 Percentage of subjects
Interval 95.0 to 100.0
|
98 Percentage of subjects
Interval 94.0 to 100.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Polio Type 2 - ≥1:8 (N=185,179)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Polio Type 3 - ≥1:8 (N=164,162)
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Hepatitis B - ≥10 mIU/mL (N=138,148)
|
96 Percentage of subjects
Interval 92.0 to 99.0
|
97 Percentage of subjects
Interval 92.0 to 99.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PRP-Hib - ≥0.15 μg/mL (N=187,194)
|
95 Percentage of subjects
Interval 90.0 to 97.0
|
89 Percentage of subjects
Interval 84.0 to 93.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 4 - ≥0.35 μg/mL (N=183,178)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
98 Percentage of subjects
Interval 94.0 to 99.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 6B - ≥0.35 μg/mL (N=183,178)
|
86 Percentage of subjects
Interval 80.0 to 91.0
|
90 Percentage of subjects
Interval 84.0 to 94.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 9V - ≥0.35 μg/mL (N=183,178)
|
91 Percentage of subjects
Interval 86.0 to 95.0
|
94 Percentage of subjects
Interval 90.0 to 97.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 14 - ≥0.35 μg/mL (N=183,178)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 19F - ≥0.35 μg/mL (N=183,178)
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
|
Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 23F - ≥0.35 μg/mL (N=183,178)
|
89 Percentage of subjects
Interval 83.0 to 89.0
|
94 Percentage of subjects
Interval 89.0 to 97.0
|
SECONDARY outcome
Timeframe: One month after third dose of routine infant series vaccinationPopulation: Analysis was performed on the PP datasets of infants for concomitant, pertussis and hepatitis B vaccinations
The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=207 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=218 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
FHA (N=185,191)
|
48 μg/mL
Interval 43.0 to 54.0
|
47 μg/mL
Interval 42.0 to 52.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Pertactin (N=185,191)
|
56 μg/mL
Interval 47.0 to 65.0
|
54 μg/mL
Interval 46.0 to 62.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
FIM (N=185,191)
|
133 μg/mL
Interval 113.0 to 157.0
|
122 μg/mL
Interval 105.0 to 143.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Polio Type 1 (N=115,113)
|
149 μg/mL
Interval 115.0 to 194.0
|
117 μg/mL
Interval 89.0 to 152.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Polio Type 3 (N=164,162)
|
457 μg/mL
Interval 367.0 to 569.0
|
402 μg/mL
Interval 321.0 to 504.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 19F (N=183,178)
|
1.84 μg/mL
Interval 1.63 to 2.08
|
2.04 μg/mL
Interval 1.8 to 2.32
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 23F (N=183,178)
|
1.15 μg/mL
Interval 0.99 to 1.35
|
1.33 μg/mL
Interval 1.13 to 1.56
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Diphtheria (N=207,218)
|
0.7 μg/mL
Interval 0.63 to 0.78
|
0.85 μg/mL
Interval 0.76 to 0.94
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Tetanus (N=207,218)
|
0.8 μg/mL
Interval 0.7 to 0.91
|
0.67 μg/mL
Interval 0.59 to 0.76
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PT (N=185,191)
|
25 μg/mL
Interval 21.0 to 30.0
|
24 μg/mL
Interval 21.0 to 29.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Polio Type 2 (N=185,179)
|
210 μg/mL
Interval 178.0 to 246.0
|
185 μg/mL
Interval 156.0 to 218.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Hepatitis B (N=138,148)
|
394 μg/mL
Interval 284.0 to 546.0
|
402 μg/mL
Interval 289.0 to 558.0
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
Hib (N=187,194)
|
3.75 μg/mL
Interval 2.92 to 4.82
|
2.76 μg/mL
Interval 2.16 to 3.53
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 4 (N=183,178)
|
1.3 μg/mL
Interval 1.16 to 1.46
|
1.45 μg/mL
Interval 1.29 to 1.63
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 6B (N=183,178)
|
1.42 μg/mL
Interval 1.17 to 1.72
|
1.79 μg/mL
Interval 1.47 to 2.18
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 9V (N=183,178)
|
0.95 μg/mL
Interval 0.84 to 1.08
|
1.2 μg/mL
Interval 1.05 to 1.36
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 14 (N=183,178)
|
6.31 μg/mL
Interval 5.45 to 7.31
|
6.61 μg/mL
Interval 5.69 to 7.68
|
|
Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
PnC 18C (N=183,178)
|
1.36 μg/mL
Interval 1.2 to 1.55
|
1.42 μg/mL
Interval 1.24 to 1.62
|
SECONDARY outcome
Timeframe: One month after PCV toddler vaccinationPopulation: Analysis was performed on the PP pneumococcal toddler population.
Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=161 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=170 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 9V (N=161,170)
|
1.67 μg/mL
Interval 1.44 to 1.93
|
1.91 μg/mL
Interval 1.66 to 2.19
|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 4 (N=161,170)
|
1.57 μg/mL
Interval 1.35 to 1.82
|
1.6 μg/mL
Interval 1.39 to 1.85
|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 6B (N=161,170)
|
5.92 μg/mL
Interval 5.05 to 6.95
|
7.8 μg/mL
Interval 6.69 to 9.09
|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 14 (N=161,170)
|
7.9 μg/mL
Interval 6.73 to 9.28
|
7.61 μg/mL
Interval 6.52 to 8.88
|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 18C (N=161,170)
|
1.79 μg/mL
Interval 1.55 to 2.08
|
1.8 μg/mL
Interval 1.57 to 2.08
|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 19F (N=161,170)
|
5.03 μg/mL
Interval 4.36 to 5.82
|
5.68 μg/mL
Interval 4.95 to 6.53
|
|
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 23F (N=161,170)
|
3.3 μg/mL
Interval 2.8 to 3.89
|
3.91 μg/mL
Interval 3.34 to 4.57
|
SECONDARY outcome
Timeframe: One month after PCV toddler vaccinationPopulation: Analysis was performed on the PP pneumococcal toddler population.
The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=161 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=170 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 9V (N=161,170)
|
97 Percentage of subjects
Interval 93.0 to 99.0
|
96 Percentage of subjects
Interval 92.0 to 98.0
|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 23F (N=161,170)
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
98 Percentage of subjects
Interval 94.0 to 99.0
|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 4 (N=161,170)
|
93 Percentage of subjects
Interval 88.0 to 97.0
|
96 Percentage of subjects
Interval 92.0 to 98.0
|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 6B (N=161,170)
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
98 Percentage of subjects
Interval 95.0 to 100.0
|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 14 (N=161,170)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
99 Percentage of subjects
Interval 97.0 to 100.0
|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 18C (N=161,170)
|
96 Percentage of subjects
Interval 92.0 to 99.0
|
98 Percentage of subjects
Interval 94.0 to 99.0
|
|
Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
PnC 19F (N=161,169)
|
99 Percentage of subjects
Interval 96.0 to 100.0
|
100 Percentage of subjects
Interval 98.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline and Six months after third infant dose of MenACWY-CRMPopulation: Analysis was performed on the PP toddler dataset for MenACWY-CRM.
The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=170 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=178 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup C - Baseline (N=126,136)
|
7 Percentage of subjects
Interval 3.0 to 13.0
|
8 Percentage of subjects
Interval 4.0 to 14.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup W - 6 mo Post-3rd dose (N=153,165)
|
70 Percentage of subjects
Interval 62.0 to 77.0
|
5 Percentage of subjects
Interval 2.0 to 9.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup Y - 6 mo Post-3rd dose (N=153,159)
|
53 Percentage of subjects
Interval 45.0 to 61.0
|
3 Percentage of subjects
Interval 1.0 to 6.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup A - Baseline (N=139, 145)
|
1 Percentage of subjects
Interval 0.0 to 5.0
|
0 Percentage of subjects
Interval 0.0 to 3.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup A - 6 mo Post-3rd dose (N=168,175)
|
7 Percentage of subjects
Interval 4.0 to 12.0
|
2 Percentage of subjects
Interval 0.0 to 5.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup C - 6 mo Post-3rd dose (N=156,171)
|
37 Percentage of subjects
Interval 30.0 to 45.0
|
2 Percentage of subjects
Interval 1.0 to 6.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup W - Baseline (N=152,164)
|
15 Percentage of subjects
Interval 9.0 to 23.0
|
15 Percentage of subjects
Interval 9.0 to 23.0
|
|
Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup Y - Baseline (N=108,113)
|
6 Percentage of subjects
Interval 3.0 to 13.0
|
5 Percentage of subjects
Interval 2.0 to 11.0
|
SECONDARY outcome
Timeframe: Baseline and Six months after third infant dose of MenACWY-CRMPopulation: Analysis was performed on the PP toddler dataset for MenACWY-CRM.
The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=170 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=178 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup C - 6 mo Post-3rd dose (N=156,171)
|
5.98 Titers
Interval 4.81 to 7.43
|
2.15 Titers
Interval 2.02 to 2.3
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup W - Baseline (N=113,126)
|
2.99 Titers
Interval 2.49 to 3.6
|
2.97 Titers
Interval 2.52 to 3.51
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup A - Baseline (N=139, 145)
|
2.07 Titers
Interval 1.98 to 2.16
|
2.01 Titers
Interval 1.99 to 2.03
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup A - 6 mo Post-3rd dose (N=168,175)
|
2.52 Titers
Interval 2.26 to 2.82
|
2.12 Titers
Interval 2.0 to 2.25
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup C - Baseline (N=126,136)
|
2.49 Titers
Interval 2.2 to 2.83
|
2.44 Titers
Interval 2.2 to 2.7
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup W - 6 mo Post-3rd dose (N=153,165)
|
15 Titers
Interval 12.0 to 18.0
|
2.23 Titers
Interval 2.06 to 2.4
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup Y - Baseline (N=108,113)
|
2.43 Titers
Interval 2.19 to 2.71
|
2.32 Titers
Interval 2.13 to 2.52
|
|
Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
Serogroup Y - 6 mo Post-3rd dose (N=153,159)
|
8.39 Titers
Interval 6.9 to 10.0
|
2.09 Titers
Interval 2.0 to 2.19
|
SECONDARY outcome
Timeframe: One month after MenACWY-CRM toddler vaccinationPopulation: Analysis was performed on the PP toddler dataset for MenACWY-CRM.
The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=168 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=175 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup C (N=156,171)
|
92 Percentage of subjects
Interval 87.0 to 96.0
|
1 Percentage of subjects
Interval 0.0 to 4.0
|
|
Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup W (N=153,165)
|
95 Percentage of subjects
Interval 91.0 to 98.0
|
2 Percentage of subjects
Interval 1.0 to 6.0
|
|
Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup Y (N=153,159)
|
96 Percentage of subjects
Interval 92.0 to 99.0
|
1 Percentage of subjects
Interval 0.016 to 3.0
|
|
Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Serogroup A (N=168,175)
|
89 Percentage of subjects
Interval 83.0 to 93.0
|
1 Percentage of subjects
Interval 0.014 to 3.0
|
SECONDARY outcome
Timeframe: From day 1 to 18 monthsPopulation: Analysis was performed on the safety dataset, i.e. all subjects in the exposed population who provided postbaseline safety data
Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination. Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.
Outcome measures
| Measure |
MenACWY-CRM + Routine Vaccines
n=255 Participants
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=270 Participants
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Entire study - Any AEs
|
228 Number of subjects
|
239 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Up to 7 months - At least possibly related AEs
|
6 Number of subjects
|
1 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 2- and 4-months - Serious AEs
|
5 Number of subjects
|
5 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 6- and 12-months - Any AEs
|
187 Number of subjects
|
197 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
28 days post-toddler-At least possibly related AEs
|
0 Number of subjects
|
0 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Entire study - At least possibly related AEs
|
6 Number of subjects
|
2 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Entire study - Serious AEs
|
21 Number of subjects
|
20 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Up to 7 months - Any AEs
|
183 Number of subjects
|
189 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Up to 7 months - Serious AEs
|
7 Number of subjects
|
8 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 2- and 4-months - Any AEs
|
99 Number of subjects
|
105 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 2- & 4-mo - At least possibly related AEs
|
1 Number of subjects
|
0 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 4- and 6-months - Any AEs
|
118 Number of subjects
|
114 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 4- & 6-mo - At least possibly related AEs
|
3 Number of subjects
|
0 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 4- and 6-months - Serious AEs
|
2 Number of subjects
|
2 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 6- & 12-mo - At least possibly related AEs
|
2 Number of subjects
|
1 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 6- and 12-months - Serious AEs
|
10 Number of subjects
|
2 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 7- and 12-months - Any AEs
|
175 Number of subjects
|
181 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 7- & 12-mo - At least possibly related AEs
|
0 Number of subjects
|
0 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 7- and 12-months - Serious AEs
|
9 Number of subjects
|
2 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
28 days post-toddler - Any AEs
|
80 Number of subjects
|
78 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
28 days post-toddler - Serious AEs
|
1 Number of subjects
|
1 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 29 days and study termination - Any AEs
|
137 Number of subjects
|
137 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
B/w 29 days & study terminat-Possibly related AEs
|
0 Number of subjects
|
0 Number of subjects
|
|
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Between 29 days and study termination - SeriousAEs
|
7 Number of subjects
|
11 Number of subjects
|
Adverse Events
MenACWY-CRM + Routine Vaccines
Serious events: 21 serious events
Other events: 216 other events
Deaths: 0 deaths
Routine Vaccines
Serious events: 20 serious events
Other events: 227 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenACWY-CRM + Routine Vaccines
n=255 participants at risk
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=270 participants at risk
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Laryngomalacia
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Abscess
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.74%
2/270 • Number of events 2 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Bronchiolitis
|
1.6%
4/255 • Number of events 4 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.74%
2/270 • Number of events 2 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.74%
2/270 • Number of events 2 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Croup infectious
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
1.1%
3/270 • Number of events 3 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Meningitis enteroviral
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Metapneumovirus infection
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Otitis media
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Pneumonia
|
0.78%
2/255 • Number of events 2 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Pneumonia parainfluenzae viral
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Pneumonia viral
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Pyelonephritis
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.2%
3/255 • Number of events 3 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.74%
2/270 • Number of events 2 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Sinusitis
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Subcutaneous abscess
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Tonsillitis
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.74%
2/270 • Number of events 2 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Viral infection
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Investigations
Moraxella test positive
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Nervous system disorders
Cognitive disorder
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Nervous system disorders
Febrile convulsion
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Nervous system disorders
Hypotonia
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Nervous system disorders
Sensory disturbance
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Reproductive system and breast disorders
Vaginal laceration
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.39%
1/255 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.00%
0/270 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Surgical and medical procedures
Colectomy
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Surgical and medical procedures
Colostomy
|
0.00%
0/255 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
0.37%
1/270 • Number of events 1 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
Other adverse events
| Measure |
MenACWY-CRM + Routine Vaccines
n=255 participants at risk
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
Routine Vaccines
n=270 participants at risk
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
|
|---|---|---|
|
Infections and infestations
Viral infection
|
14.1%
36/255 • Number of events 36 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
18.9%
51/270 • Number of events 51 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Upper respiratory tract infection
|
56.5%
144/255 • Number of events 144 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
57.0%
154/270 • Number of events 154 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Eye disorders
Conjunctivitis
|
22.7%
58/255 • Number of events 58 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
19.3%
52/270 • Number of events 52 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
18/255 • Number of events 18 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
8.9%
24/270 • Number of events 24 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.8%
25/255 • Number of events 25 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
9.6%
26/270 • Number of events 26 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Teething
|
6.3%
16/255 • Number of events 16 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
2.6%
7/270 • Number of events 7 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Gastrointestinal disorders
Vomiting
|
7.5%
19/255 • Number of events 19 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
11.5%
31/270 • Number of events 31 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
General disorders
Pyrexia
|
16.9%
43/255 • Number of events 43 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
16.7%
45/270 • Number of events 45 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Bronchiolitis
|
14.5%
37/255 • Number of events 37 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
14.8%
40/270 • Number of events 40 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Bronchitis
|
5.9%
15/255 • Number of events 15 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
5.6%
15/270 • Number of events 15 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Candida Nappy Rash
|
2.4%
6/255 • Number of events 6 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
6.3%
17/270 • Number of events 17 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Candidiasis
|
6.3%
16/255 • Number of events 16 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
8.9%
24/270 • Number of events 24 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Croup Infectious
|
5.9%
15/255 • Number of events 15 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
7.8%
21/270 • Number of events 21 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Gastroenteritis
|
14.9%
38/255 • Number of events 38 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
11.9%
32/270 • Number of events 32 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Otitis media
|
39.2%
100/255 • Number of events 100 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
39.3%
106/270 • Number of events 106 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Otitis media acute
|
12.2%
31/255 • Number of events 31 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
11.5%
31/270 • Number of events 31 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Pharyngitis
|
9.4%
24/255 • Number of events 24 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
11.9%
32/270 • Number of events 32 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Rhinitis
|
7.5%
19/255 • Number of events 19 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
7.4%
20/270 • Number of events 20 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Infections and infestations
Sinusitis
|
3.9%
10/255 • Number of events 10 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
5.6%
15/270 • Number of events 15 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
5.9%
15/255 • Number of events 15 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
3.0%
8/270 • Number of events 8 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.3%
34/255 • Number of events 34 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
10.0%
27/270 • Number of events 27 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.7%
17/255 • Number of events 17 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
7.8%
21/270 • Number of events 21 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.3%
16/255 • Number of events 16 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
3.0%
8/270 • Number of events 8 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
6.7%
17/255 • Number of events 17 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
6.3%
17/270 • Number of events 17 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
12.9%
33/255 • Number of events 33 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
14.8%
40/270 • Number of events 40 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
11.4%
29/255 • Number of events 29 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
10.4%
28/270 • Number of events 28 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
13/255 • Number of events 13 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
5.6%
15/270 • Number of events 15 • Serious adverse events (AEs) were collected throughout the study (from day 1 to 18 months).
Non-serious AEs were also collected throughout the study (from day 1 to 18 months). The number of subjects reported here is from the safety set and not from the enrolled set as reported in the Participant Flow module.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60