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Trial Outcomes & Findings for Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants (NCT NCT00262002)

NCT ID: NCT00262002

Last Updated: 2014-06-18

Results Overview

Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

601 participants

Primary outcome timeframe

Baseline and at 1 month after the 3 dose primary vaccination series

Results posted on

2014-06-18

Participant Flow

Participants were enrolled at two centers in Canada and one in UK.

The two selected countries provided data on different infant vaccination schedules (at 2 and 4 months of age; at 2, 3, and 4 months of age: and at 2, 4, and 6 months of age), and on different recommended concomitant vaccinations.

Participant milestones

Participant milestones
Measure
UK234+ (MenACWY Ad+ at 2,3,4 m)
Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
UK24+ (MenACWY Ad+ at 2,4 m)
Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
UKMenC (Menjugate at 2,4m)
Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2,4,6m)
Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24+ (MenACWY Ad+ at 2,4m)
Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2,4m)
Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2,4m)
Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Overall Study
STARTED
90
90
45
98
98
90
90
Overall Study
COMPLETED
79
84
45
93
91
83
84
Overall Study
NOT COMPLETED
11
6
0
5
7
7
6

Reasons for withdrawal

Reasons for withdrawal
Measure
UK234+ (MenACWY Ad+ at 2,3,4 m)
Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
UK24+ (MenACWY Ad+ at 2,4 m)
Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
UKMenC (Menjugate at 2,4m)
Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2,4,6m)
Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24+ (MenACWY Ad+ at 2,4m)
Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2,4m)
Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2,4m)
Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Overall Study
Adverse Event
2
1
0
0
0
1
0
Overall Study
Withdrawal by Subject
4
2
0
1
2
2
2
Overall Study
Lost to Follow-up
2
0
0
2
0
1
0
Overall Study
Inapropriate enrollment
0
1
0
0
0
0
0
Overall Study
Protocol Violation
3
2
0
2
5
3
2
Overall Study
Unable to classify
0
0
0
0
0
0
2

Baseline Characteristics

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
UK234+ (MenACWY Ad+ at 2,3,4 m)
n=90 Participants
Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
UK24+ (MenACWY Ad+ at 2,4 m)
n=90 Participants
Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
UKMenC (Menjugate at 2,4m)
n=45 Participants
Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2,4,6m)
n=98 Participants
Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24+ (MenACWY Ad+ at 2,4m)
n=98 Participants
Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2,4m)
n=90 Participants
Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2,4m)
n=90 Participants
Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Total
n=601 Participants
Total of all reporting groups
Age, Continuous
62.1 days
STANDARD_DEVIATION 5.4 • n=5 Participants
61.3 days
STANDARD_DEVIATION 5.0 • n=7 Participants
62.6 days
STANDARD_DEVIATION 6.5 • n=5 Participants
65.6 days
STANDARD_DEVIATION 6.9 • n=4 Participants
65.8 days
STANDARD_DEVIATION 6.9 • n=21 Participants
64.1 days
STANDARD_DEVIATION 5.5 • n=10 Participants
69.4 days
STANDARD_DEVIATION 10.0 • n=115 Participants
64.6 days
STANDARD_DEVIATION 7.3 • n=24 Participants
Sex: Female, Male
Female
44 Participants
n=5 Participants
41 Participants
n=7 Participants
26 Participants
n=5 Participants
52 Participants
n=4 Participants
49 Participants
n=21 Participants
48 Participants
n=10 Participants
44 Participants
n=115 Participants
304 Participants
n=24 Participants
Sex: Female, Male
Male
46 Participants
n=5 Participants
49 Participants
n=7 Participants
19 Participants
n=5 Participants
46 Participants
n=4 Participants
49 Participants
n=21 Participants
42 Participants
n=10 Participants
46 Participants
n=115 Participants
297 Participants
n=24 Participants

PRIMARY outcome

Timeframe: Baseline and at 1 month after the 3 dose primary vaccination series

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.

Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=81 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=87 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser A - baseline (n=69,80)
—
—
6 percentages of subjects
Interval 2.0 to 14.0
—
0 percentages of subjects
Interval 0.0 to 5.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser A - 1 month after primary vacc (n=69,80)
—
—
93 percentages of subjects
Interval 84.0 to 98.0
—
81 percentages of subjects
Interval 71.0 to 89.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser C - baseline (n=79,86)
—
—
18 percentages of subjects
Interval 10.0 to 28.0
—
15 percentages of subjects
Interval 8.0 to 24.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser C - 1 month after primary vacc (n=79,86)
—
—
96 percentages of subjects
Interval 89.0 to 99.0
—
98 percentages of subjects
Interval 92.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser W - baseline (n=69,78)
—
—
54 percentages of subjects
Interval 41.0 to 66.0
—
31 percentages of subjects
Interval 21.0 to 42.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser W - 1 month after primary vacc (n=69,78)
—
—
97 percentages of subjects
Interval 90.0 to 100.0
—
99 percentages of subjects
Interval 93.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser Y - baseline
—
—
21 percentages of subjects
Interval 13.0 to 31.0
—
17 percentages of subjects
Interval 10.0 to 27.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Ser Y - 1 month after primary vacc
—
—
94 percentages of subjects
Interval 86.0 to 98.0
—
98 percentages of subjects
Interval 92.0 to 100.0
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after the 3 dose primary vaccination series

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.

Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=81 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=87 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - 1 month after primary vacc (n=79,86)
—
—
92 percentages of subjects
Interval 84.0 to 97.0
—
98 percentages of subjects
Interval 92.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - baseline (n=69,78)
—
—
46 percentages of subjects
Interval 34.0 to 59.0
—
28 percentages of subjects
Interval 19.0 to 40.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - baseline (n=69,80)
—
—
4 percentages of subjects
Interval 1.0 to 12.0
—
0 percentages of subjects
Interval 0.0 to 5.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - 1 month after primary vacc (n=69,80)
—
—
88 percentages of subjects
Interval 78.0 to 95.0
—
76 percentages of subjects
Interval 65.0 to 85.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - baseline (n=79,86)
—
—
9 percentages of subjects
Interval 4.0 to 17.0
—
5 percentages of subjects
Interval 1.0 to 11.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - 1 month after primary vacc (n=69,78)
—
—
88 percentages of subjects
Interval 78.0 to 95.0
—
96 percentages of subjects
Interval 89.0 to 99.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - baseline
—
—
14 percentages of subjects
Interval 7.0 to 23.0
—
11 percentages of subjects
Interval 6.0 to 20.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - 1 month after primary vaccination
—
—
93 percentages of subjects
Interval 85.0 to 97.0
—
89 percentages of subjects
Interval 80.0 to 94.0
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after the 3 dose primary vaccination series

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.

Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=81 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=87 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - baseline (n=69,80)
—
—
2.2 titers
Interval 2.04 to 2.38
—
2 titers
Interval 1.86 to 2.15
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - 1 month after primary vacc (n=69,80)
—
—
53 titers
Interval 38.0 to 74.0
—
21 titers
Interval 15.0 to 29.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - baseline (n=79,86)
—
—
2.79 titers
Interval 2.36 to 3.31
—
2.64 titers
Interval 2.25 to 3.11
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - 1 month after primary vacc (n=79,86)
—
—
79 titers
Interval 56.0 to 112.0
—
124 titers
Interval 89.0 to 172.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - baseline (n=69,78)
—
—
5.76 titers
Interval 4.39 to 7.57
—
4.03 titers
Interval 3.12 to 5.21
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - 1 month after primary vacc (n=69,78)
—
—
65 titers
Interval 46.0 to 92.0
—
73 titers
Interval 53.0 to 102.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - baseline
—
—
2.72 titers
Interval 2.34 to 3.17
—
2.64 titers
Interval 2.28 to 3.05
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - 1 month after primary vacc
—
—
56 titers
Interval 41.0 to 77.0
—
2.64 titers
Interval 2.28 to 3.05
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after second vaccination

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population.

Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=85 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=77 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=79 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=79 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85)
86 percentages of subjects
Interval 77.0 to 92.0
—
76 percentages of subjects
Interval 65.0 to 85.0
70 percentages of subjects
Interval 59.0 to 80.0
80 percentages of subjects
Interval 69.0 to 88.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83)
49 percentages of subjects
Interval 38.0 to 61.0
—
54 percentages of subjects
Interval 42.0 to 67.0
44 percentages of subjects
Interval 32.0 to 55.0
58 percentages of subjects
Interval 47.0 to 69.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser C - hSBA ≥1:4, baseline (N=77,74,79,85)
20 percentages of subjects
Interval 12.0 to 30.0
—
13 percentages of subjects
Interval 6.0 to 23.0
20 percentages of subjects
Interval 12.0 to 31.0
15 percentages of subjects
Interval 8.0 to 25.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75)
92 percentages of subjects
Interval 83.0 to 97.0
—
84 percentages of subjects
Interval 73.0 to 91.0
75 percentages of subjects
Interval 63.0 to 84.0
85 percentages of subjects
Interval 75.0 to 92.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85)
91 percentages of subjects
Interval 82.0 to 96.0
—
84 percentages of subjects
Interval 74.0 to 92.0
74 percentages of subjects
Interval 63.0 to 83.0
86 percentages of subjects
Interval 77.0 to 93.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser A - hSBA ≥1:4, baseline (N=68,79,78,83)
4 percentages of subjects
Interval 1.0 to 10.0
—
4 percentages of subjects
Interval 1.0 to 12.0
3 percentages of subjects
Interval 0.0 to 9.0
3 percentages of subjects
Interval 0.0 to 9.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83)
57 percentages of subjects
Interval 45.0 to 67.0
—
60 percentages of subjects
Interval 48.0 to 72.0
50 percentages of subjects
Interval 38.0 to 62.0
66 percentages of subjects
Interval 54.0 to 76.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser A - hSBA ≥1:8, baseline (N=68,79,78,83)
1 percentages of subjects
Interval 0.03 to 7.0
—
3 percentages of subjects
Interval 0.0 to 10.0
0 percentages of subjects
Interval 0.0 to 5.0
1 percentages of subjects
Interval 0.032 to 7.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85)
93 percentages of subjects
Interval 85.0 to 97.0
—
84 percentages of subjects
Interval 74.0 to 92.0
86 percentages of subjects
Interval 76.0 to 93.0
91 percentages of subjects
Interval 81.0 to 96.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser C - hSBA ≥1:8, baseline (N=77,74,79,85)
11 percentages of subjects
Interval 5.0 to 19.0
—
9 percentages of subjects
Interval 4.0 to 18.0
5 percentages of subjects
Interval 1.0 to 12.0
15 percentages of subjects
Interval 8.0 to 25.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85)
89 percentages of subjects
Interval 81.0 to 95.0
—
83 percentages of subjects
Interval 73.0 to 91.0
82 percentages of subjects
Interval 72.0 to 90.0
85 percentages of subjects
Interval 75.0 to 92.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser W - hSBA ≥1:4, baseline (N=73,74,72,75)
19 percentages of subjects
Interval 11.0 to 29.0
—
45 percentages of subjects
Interval 34.0 to 57.0
43 percentages of subjects
Interval 31.0 to 55.0
24 percentages of subjects
Interval 15.0 to 36.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75)
95 percentages of subjects
Interval 87.0 to 99.0
—
92 percentages of subjects
Interval 83.0 to 97.0
82 percentages of subjects
Interval 71.0 to 90.0
91 percentages of subjects
Interval 81.0 to 96.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser W - hSBA ≥1:8, baseline (N=73,74,72,75)
16 percentages of subjects
Interval 9.0 to 26.0
—
37 percentages of subjects
Interval 26.0 to 49.0
36 percentages of subjects
Interval 25.0 to 48.0
19 percentages of subjects
Interval 11.0 to 30.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85)
18 percentages of subjects
Interval 10.0 to 27.0
—
18 percentages of subjects
Interval 10.0 to 29.0
35 percentages of subjects
Interval 25.0 to 47.0
9 percentages of subjects
Interval 4.0 to 19.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85)
11 percentages of subjects
Interval 5.0 to 19.0
—
7 percentages of subjects
Interval 2.0 to 15.0
16 percentages of subjects
Interval 8.0 to 26.0
4 percentages of subjects
Interval 1.0 to 11.0
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after second vaccination

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population

Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=85 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=77 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=79 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=79 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser W - baseline (n=73,74,79,75)
3.02 titers
Interval 2.33 to 3.93
—
5.33 titers
Interval 4.09 to 6.94
5.14 titers
Interval 3.94 to 6.71
3.6 titers
Interval 2.77 to 4.69
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser W - 1 month after 2nd vacc (n=73,74,79,75)
69 titers
Interval 50.0 to 96.0
—
48 titers
Interval 34.0 to 67.0
29 titers
Interval 20.0 to 40.0
44 titers
Interval 31.0 to 61.0
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser Y - 1 month after 2nd vacc (n=76,74,77,85)
41 titers
Interval 30.0 to 56.0
—
26 titers
Interval 19.0 to 37.0
21 titers
Interval 15.0 to 29.0
27 titers
Interval 19.0 to 38.0
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser A - baseline (n=68,79,78,83)
2.08 titers
Interval 1.94 to 2.23
—
2.17 titers
Interval 2.01 to 2.35
2.05 titers
Interval 1.91 to 2.21
2.07 titers
Interval 1.93 to 2.23
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser A - 1 month after 2nd vacc (n=68,79,78,83)
7.16 titers
Interval 5.26 to 9.73
—
12 titers
Interval 8.36 to 16.0
7.3 titers
Interval 5.31 to 10.0
11 titers
Interval 7.91 to 15.0
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser C - baseline (n=77,74,79,85)
2.87 titers
Interval 2.44 to 3.39
—
2.54 titers
Interval 2.14 to 3.02
2.48 titers
Interval 2.09 to 2.94
2.77 titers
Interval 2.33 to 3.31
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser C - 1 month after 2nd vacc (n=77,74,79,85)
69 titers
Interval 49.0 to 96.0
—
52 titers
Interval 37.0 to 74.0
40 titers
Interval 28.0 to 57.0
55 titers
Interval 38.0 to 79.0
—
—
—
—
—
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Ser Y - baseline (n=76,74,77,85)
2.76 titers
Interval 2.38 to 3.21
—
2.56 titers
Interval 2.19 to 2.99
3.39 titers
Interval 2.9 to 3.96
2.27 titers
Interval 1.94 to 2.66
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age and 1 month after booster vaccination

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=40 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=40 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=67 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=65 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=63 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser A -hSBA≥1:4, 1 m after booster vacc
92 percentages of subjects
Interval 79.0 to 98.0
95 percentages of subjects
Interval 82.0 to 99.0
86 percentages of subjects
Interval 75.0 to 93.0
94 percentages of subjects
Interval 84.0 to 98.0
79 percentages of subjects
Interval 66.0 to 88.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40)
95 percentages of subjects
Interval 83.0 to 99.0
100 percentages of subjects
Interval 91.0 to 100.0
96 percentages of subjects
Interval 87.0 to 99.0
98 percentages of subjects
Interval 92.0 to 100.0
94 percentages of subjects
Interval 85.0 to 98.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser W - hSBA≥1:4, 1m after booster vaccination
100 percentages of subjects
Interval 90.0 to 100.0
100 percentages of subjects
Interval 90.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
100 percentages of subjects
Interval 91.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser Y - hSBA≥1:4, 1 m after booster vaccination
100 percentages of subjects
Interval 91.0 to 100.0
100 percentages of subjects
Interval 91.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser Y - hSBA ≥1:8, at 12 months of age
45 percentages of subjects
Interval 29.0 to 62.0
53 percentages of subjects
Interval 36.0 to 69.0
39 percentages of subjects
Interval 28.0 to 52.0
72 percentages of subjects
Interval 60.0 to 83.0
41 percentages of subjects
Interval 29.0 to 54.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser Y - hSBA ≥1:8, 1 m after booster vaccination
100 percentages of subjects
Interval 91.0 to 100.0
100 percentages of subjects
Interval 91.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38)
5 percentages of subjects
Interval 1.0 to 17.0
3 percentages of subjects
Interval 0.067 to 14.0
8 percentages of subjects
Interval 3.0 to 17.0
21 percentages of subjects
Interval 12.0 to 33.0
7 percentages of subjects
Interval 2.0 to 16.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser A - hSBA ≥1:8, at 12 months of age
3 percentages of subjects
Interval 0.065 to 13.0
3 percentages of subjects
Interval 0.067 to 14.0
5 percentages of subjects
Interval 1.0 to 13.0
13 percentages of subjects
Interval 6.0 to 24.0
5 percentages of subjects
Interval 1.0 to 14.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser A - hSBA ≥1:8, 1 m after booster vaccination
90 percentages of subjects
Interval 76.0 to 97.0
92 percentages of subjects
Interval 79.0 to 98.0
83 percentages of subjects
Interval 71.0 to 91.0
92 percentages of subjects
Interval 82.0 to 97.0
77 percentages of subjects
Interval 65.0 to 87.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40)
48 percentages of subjects
Interval 32.0 to 64.0
33 percentages of subjects
Interval 19.0 to 49.0
40 percentages of subjects
Interval 28.0 to 53.0
60 percentages of subjects
Interval 47.0 to 72.0
33 percentages of subjects
Interval 22.0 to 46.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40)
98 percentages of subjects
Interval 87.0 to 100.0
100 percentages of subjects
Interval 91.0 to 100.0
96 percentages of subjects
Interval 87.0 to 99.0
98 percentages of subjects
Interval 92.0 to 100.0
94 percentages of subjects
Interval 85.0 to 98.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40)
35 percentages of subjects
Interval 21.0 to 52.0
25 percentages of subjects
Interval 13.0 to 41.0
34 percentages of subjects
Interval 23.0 to 47.0
52 percentages of subjects
Interval 40.0 to 65.0
27 percentages of subjects
Interval 17.0 to 40.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35)
74 percentages of subjects
Interval 57.0 to 88.0
69 percentages of subjects
Interval 51.0 to 83.0
56 percentages of subjects
Interval 42.0 to 69.0
81 percentages of subjects
Interval 68.0 to 90.0
54 percentages of subjects
Interval 37.0 to 69.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35)
49 percentages of subjects
Interval 31.0 to 66.0
54 percentages of subjects
Interval 37.0 to 71.0
47 percentages of subjects
Interval 34.0 to 61.0
68 percentages of subjects
Interval 55.0 to 80.0
41 percentages of subjects
Interval 26.0 to 58.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35)
100 percentages of subjects
Interval 90.0 to 100.0
100 percentages of subjects
Interval 90.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
100 percentages of subjects
Interval 94.0 to 100.0
100 percentages of subjects
Interval 91.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38)
65 percentages of subjects
Interval 48.0 to 79.0
63 percentages of subjects
Interval 46.0 to 78.0
52 percentages of subjects
Interval 39.0 to 64.0
86 percentages of subjects
Interval 75.0 to 93.0
52 percentages of subjects
Interval 39.0 to 65.0
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age and 1 month after booster vaccination

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=40 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=40 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=67 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=65 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=63 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser C - at 12 months of age(n=67,63,65,40,40)
4.64 titers
Interval 3.11 to 6.91
4.07 titers
Interval 2.73 to 6.06
5.18 titers
Interval 3.83 to 7.02
7.94 titers
Interval 5.84 to 11.0
3.94 titers
Interval 2.88 to 5.39
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser C - 1 month after booster(n=67,63,65,40,40)
216 titers
Interval 130.0 to 356.0
258 titers
Interval 56.0 to 426.0
236 titers
Interval 159.0 to 349.0
429 titers
Interval 288.0 to 639.0
129 titers
Interval 86.0 to 194.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser A - at 12 months of age (n=64,61,62,39,38)
2.18 titers
Interval 1.74 to 2.73
2.07 titers
Interval 1.65 to 2.6
2.31 titers
Interval 2.0 to 2.66
2.97 titers
Interval 2.57 to 3.44
2.22 titers
Interval 1.92 to 2.57
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser A - 1 month after booster (n=64,61,62,39,38)
67 titers
Interval 43.0 to 106.0
59 titers
Interval 38.0 to 93.0
47 titers
Interval 31.0 to 72.0
134 titers
Interval 87.0 to 207.0
30 titers
Interval 19.0 to 47.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser W - at 12 months of age(n=57,41,57,35,35)
8.84 titers
Interval 5.63 to 14.0
11 titers
Interval 7.04 to 17.0
8.1 titers
Interval 5.76 to 11.0
16 titers
Interval 11.0 to 23.0
6.49 titers
Interval 4.34 to 9.7
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser W - 1 month after booster (n=57,41,57,35,35)
381 titers
Interval 224.0 to 650.0
402 titers
Interval 236.0 to 684.0
503 titers
Interval 347.0 to 732.0
792 titers
Interval 544.0 to 1154.0
311 titers
Interval 200.0 to 485.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser Y - at 12 months of age (n=66,63,65,40,38)
7.99 titers
Interval 5.29 to 12.0
7.63 titers
Interval 5.0 to 12.0
6.65 titers
Interval 4.88 to 9.06
19 titers
Interval 14.0 to 26.0
6.83 titers
Interval 4.98 to 9.37
—
—
—
—
—
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Ser Y- 1 month after booster(n=66,63,65,40,38)
308 titers
Interval 191.0 to 499.0
527 titers
Interval 322.0 to 862.0
508 titers
Interval 358.0 to 723.0
1395 titers
Interval 979.0 to 1989.0
438 titers
Interval 305.0 to 628.0
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age

Population: The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.

The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=77 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=81 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=38 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=66 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=69 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78)
5 percentages of subjects
Interval 1.0 to 13.0
4 percentages of subjects
Interval 1.0 to 11.0
0 percentages of subjects
Interval 0.0 to 10.0
5 percentages of subjects
Interval 1.0 to 13.0
5 percentages of subjects
Interval 1.0 to 13.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69)
64 percentages of subjects
Interval 51.0 to 75.0
75 percentages of subjects
Interval 64.0 to 85.0
9 percentages of subjects
Interval 2.0 to 24.0
57 percentages of subjects
Interval 41.0 to 72.0
58 percentages of subjects
Interval 45.0 to 70.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69)
52 percentages of subjects
Interval 40.0 to 64.0
61 percentages of subjects
Interval 48.0 to 72.0
6 percentages of subjects
Interval 1.0 to 20.0
45 percentages of subjects
Interval 30.0 to 61.0
48 percentages of subjects
Interval 35.0 to 61.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79)
60 percentages of subjects
Interval 48.0 to 72.0
59 percentages of subjects
Interval 48.0 to 70.0
5 percentages of subjects
Interval 1.0 to 18.0
56 percentages of subjects
Interval 43.0 to 68.0
51 percentages of subjects
Interval 38.0 to 63.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79)
51 percentages of subjects
Interval 39.0 to 63.0
46 percentages of subjects
Interval 34.0 to 57.0
3 percentages of subjects
Interval 0.067 to 14.0
45 percentages of subjects
Interval 33.0 to 58.0
42 percentages of subjects
Interval 30.0 to 55.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78)
8 percentages of subjects
Interval 3.0 to 16.0
5 percentages of subjects
Interval 1.0 to 13.0
0 percentages of subjects
Interval 0.0 to 10.0
6 percentages of subjects
Interval 2.0 to 15.0
8 percentages of subjects
Interval 3.0 to 18.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81)
48 percentages of subjects
Interval 36.0 to 60.0
35 percentages of subjects
Interval 24.0 to 46.0
89 percentages of subjects
Interval 75.0 to 97.0
32 percentages of subjects
Interval 21.0 to 44.0
41 percentages of subjects
Interval 29.0 to 53.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81)
40 percentages of subjects
Interval 28.0 to 52.0
30 percentages of subjects
Interval 20.0 to 41.0
87 percentages of subjects
Interval 72.0 to 96.0
26 percentages of subjects
Interval 16.0 to 38.0
33 percentages of subjects
Interval 22.0 to 46.0
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age

Population: The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.

The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=77 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=81 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=38 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=66 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=69 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.
Ser A - at 12 months of age (n=36,62,65,77,78)
2.29 titers
Interval 1.98 to 2.65
2.18 titers
Interval 1.89 to 2.52
2 titers
Interval 1.62 to 2.48
2.2 titers
Interval 1.88 to 2.58
2.32 titers
Interval 1.97 to 2.73
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.
Ser C - at 12 months of age (n=36,69,69,73,82)
5.43 titers
Interval 4.05 to 7.27
4.42 titers
Interval 3.35 to 5.84
27 titers
Interval 18.0 to 40.0
3.85 titers
Interval 2.85 to 5.21
5.04 titers
Interval 3.73 to 6.81
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.
Ser Y - at 12 months of age (n=38,69,66,73,79)
7.84 titers
Interval 5.79 to 11.0
7.12 titers
Interval 5.32 to 9.54
2.15 titers
Interval 1.41 to 3.28
7.64 titers
Interval 5.55 to 11.0
6.72 titers
Interval 4.92 to 9.18
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.
Ser W - at 12 months of age (n=34,62,42,69,69)
8.15 titers
Interval 5.97 to 11.0
12 titers
Interval 8.81 to 16.0
2.42 titers
Interval 1.55 to 3.78
7.02 titers
Interval 4.71 to 10.0
8.38 titers
Interval 6.03 to 12.0
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=71 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=86 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:4, at 12 months of age (n=58,79)
—
—
21 percentages of subjects
Interval 11.0 to 33.0
—
35 percentages of subjects
Interval 25.0 to 47.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:8, at 12 months of age(n=58,79)
—
—
16 percentages of subjects
Interval 7.0 to 27.0
—
29 percentages of subjects
Interval 19.0 to 40.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:4, at 12 months of age(n=70,84)
—
—
59 percentages of subjects
Interval 46.0 to 70.0
—
75 percentages of subjects
Interval 64.0 to 84.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:8, at 12 months of age(n=70,84)
—
—
47 percentages of subjects
Interval 35.0 to 59.0
—
68 percentages of subjects
Interval 57.0 to 78.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:4, at 12 months of age(n=58,75)
—
—
78 percentages of subjects
Interval 65.0 to 87.0
—
89 percentages of subjects
Interval 80.0 to 95.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:8, at 12 months of age(n=58,75)
—
—
66 percentages of subjects
Interval 52.0 to 78.0
—
81 percentages of subjects
Interval 71.0 to 89.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86)
—
—
85 percentages of subjects
Interval 74.0 to 92.0
—
87 percentages of subjects
Interval 78.0 to 93.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86)
—
—
70 percentages of subjects
Interval 58.0 to 81.0
—
79 percentages of subjects
Interval 69.0 to 87.0
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=71 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=86 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - at 12 months of age (n=71,86)
—
—
18 Titers
Interval 13.0 to 24.0
—
22 Titers
Interval 17.0 to 29.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - at 12 months of age (n=58,79)
—
—
3.02 Titers
Interval 2.55 to 3.57
—
3.93 Titers
Interval 3.4 to 4.54
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - at 12 months of age (n=70,84)
—
—
7.56 Titers
Interval 5.61 to 10.0
—
14 Titers
Interval 10.0 to 18.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - at 12 months of age (n=58,75)
—
—
15 Titers
Interval 10.0 to 21.0
—
20 Titers
Interval 15.0 to 27.0
—
—
—
—
—

SECONDARY outcome

Timeframe: before challenge at 12 months of age and 1 month after PS challenge.

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=44 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A-hSBA≥1:4,before challenge at 12m (n=44)
—
—
27 percentages of subjects
Interval 15.0 to 43.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C-hSBA ≥1:8, before challenge at 12m (n=43)
—
—
65 percentages of subjects
Interval 49.0 to 79.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:4, 1 month after PS (n=44)
—
—
89 percentages of subjects
Interval 75.0 to 96.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A-hSBA ≥1:8,before challenge at 12m (n=44)
—
—
23 percentages of subjects
Interval 11.0 to 38.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:8, 1 month after PS (n=44)
—
—
86 percentages of subjects
Interval 73.0 to 95.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C-hSBA ≥1:4,before challenge at 12m (n=43)
—
—
74 percentages of subjects
Interval 59.0 to 86.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:4, 1 month after PS (n=43)
—
—
95 percentages of subjects
Interval 84.0 to 99.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:8, 1 month after PS (n=43)
—
—
91 percentages of subjects
Interval 78.0 to 97.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W-hSBA ≥1:4,before challenge at 12m (n=40)
—
—
83 percentages of subjects
Interval 67.0 to 93.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:4, 1 month after PS (n=40)
—
—
98 percentages of subjects
Interval 87.0 to 100.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W-hSBA ≥1:8,before challenge at 12m (n=40)
—
—
73 percentages of subjects
Interval 56.0 to 85.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:8, 1 month after PS (n=40)
—
—
95 percentages of subjects
Interval 83.0 to 99.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y-hSBA ≥1:4,before challenge at 12m (n=44)
—
—
89 percentages of subjects
Interval 75.0 to 96.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:4, 1 month after PS (n=44)
—
—
98 percentages of subjects
Interval 88.0 to 100.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y-hSBA ≥1:8,before challenge at 12m (N=44)
—
—
77 percentages of subjects
Interval 62.0 to 89.0
—
—
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:8, 1 month after PS (n=44)
—
—
98 percentages of subjects
Interval 88.0 to 100.0
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: before challenge at 12 months of age and 1 month after PS challenge.

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=44 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - before challenge at 12 months of age(n=44)
—
—
19 titers
Interval 13.0 to 28.0
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - before challenge at 12 months of age(n=44)
—
—
3.4 titers
Interval 2.75 to 4.2
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser A - 1 month after PS challenge (n=44)
—
—
32 titers
Interval 21.0 to 48.0
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - before challenge at 12 months of age(n=43)
—
—
12 titers
Interval 8.41 to 18.0
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser C - 1 month after PS challenge (n=43)
—
—
82 titers
Interval 50.0 to 133.0
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - before challenge at 12 months of age(n=40)
—
—
17 titers
Interval 11.0 to 25.0
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser W - 1 month after PS challenge (n=40)
—
—
249 titers
Interval 152.0 to 410.0
—
—
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Ser Y - 1 month after PS challenge (n=44)
—
—
186 titers
Interval 117.0 to 294.0
—
—
—
—
—
—
—

SECONDARY outcome

Timeframe: Before challenge at 12 months of age and 1 month after PS challenge.

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=42 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=39 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser C - hSBA≥1:8,before challange at 12m(n=41,39)
—
—
39 percentages of subjects
Interval 24.0 to 55.0
—
36 percentages of subjects
Interval 21.0 to 53.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser W - hSBA ≥1:4,before challange at 12m(n=41,38)
—
—
59 percentages of subjects
Interval 42.0 to 74.0
—
71 percentages of subjects
Interval 54.0 to 85.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser Y - hSBA ≥1:8, 1 month after PS (n=42,38)
—
—
98 percentages of subjects
Interval 87.0 to 100.0
—
97 percentages of subjects
Interval 86.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser A - hSBA≥1:4,before challange at 12m (n=40,39)
—
—
8 percentages of subjects
Interval 2.0 to 20.0
—
8 percentages of subjects
Interval 2.0 to 21.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser A - hSBA ≥1:4,1 month after PS (n=40,39)
—
—
78 percentages of subjects
Interval 62.0 to 89.0
—
92 percentages of subjects
Interval 79.0 to 98.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser A - hSBA≥1:8,before challange at 12m (n=40,39)
—
—
5 percentages of subjects
Interval 1.0 to 17.0
—
5 percentages of subjects
Interval 1.0 to 17.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser A - hSBA ≥1:8, 1 month after PS (n=40,39)
—
—
78 percentages of subjects
Interval 62.0 to 89.0
—
87 percentages of subjects
Interval 73.0 to 96.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser C - hSBA≥1:4,before challange at 12m (n=41,39)
—
—
44 percentages of subjects
Interval 28.0 to 60.0
—
38 percentages of subjects
Interval 23.0 to 55.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser C - hSBA ≥1:4, 1 month after PS (n=41,39)
—
—
95 percentages of subjects
Interval 83.0 to 99.0
—
95 percentages of subjects
Interval 83.0 to 99.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser C - hSBA ≥1:8, 1 month after PS (n=41,39)
—
—
93 percentages of subjects
Interval 80.0 to 98.0
—
90 percentages of subjects
Interval 76.0 to 97.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser W - hSBA ≥1:4, 1 month after PS (n=41,38)
—
—
98 percentages of subjects
Interval 87.0 to 100.0
—
100 percentages of subjects
Interval 91.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser W - hSBA ≥1:8,before challange at 12m(n=41,38)
—
—
51 percentages of subjects
Interval 35.0 to 67.0
—
58 percentages of subjects
Interval 41.0 to 74.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser W - hSBA ≥1:8, 1 month after PS (n=41,38)
—
—
98 percentages of subjects
Interval 87.0 to 100.0
—
100 percentages of subjects
Interval 91.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser Y - hSBA ≥1:4,before challange at 12m(n=42,38)
—
—
55 percentages of subjects
Interval 39.0 to 70.0
—
55 percentages of subjects
Interval 38.0 to 71.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser Y - hSBA ≥1:4, 1 month after PS (n=42,38)
—
—
98 percentages of subjects
Interval 87.0 to 100.0
—
100 percentages of subjects
Interval 91.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser Y - hSBA ≥1:8,before challange at 12m (n=42,38
—
—
50 percentages of subjects
Interval 34.0 to 66.0
—
42 percentages of subjects
Interval 26.0 to 59.0
—
—
—
—
—

SECONDARY outcome

Timeframe: Before challenge at 12 months of age and 1 month after PS challenge.

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=42 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=39 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser A - before challenge at 12 months (n=40,39)
—
—
2.22 titers
Interval 1.77 to 2.76
—
2.31 titers
Interval 1.84 to 2.89
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser W - 1 month after PS challenge (n=41,38)
—
—
365 titers
Interval 224.0 to 597.0
—
555 titers
Interval 333.0 to 924.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser Y - before challenge at 12 months (n=42,38)
—
—
6.73 titers
Interval 4.51 to 10.0
—
6.79 titers
Interval 4.45 to 10.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser A - 1 month after PS challenge (n=40,39)
—
—
28 titers
Interval 18.0 to 44.0
—
55 titers
Interval 35.0 to 86.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser C - before challenge at 12 months (n=41,39)
—
—
5.21 titers
Interval 3.51 to 7.72
—
5.07 titers
Interval 3.38 to 7.59
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser C - 1 month after PS challenge (n=41,39)
—
—
140 titers
Interval 85.0 to 231.0
—
181 titers
Interval 109.0 to 301.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser W - before challenge at 12 months (n=41,38)
—
—
7.48 titers
Interval 4.94 to 11.0
—
11 titers
Interval 7.08 to 17.0
—
—
—
—
—
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Ser Y - 1 month after PS challenge (n=42,38)
—
—
280 titers
Interval 175.0 to 448.0
—
288 titers
Interval 176.0 to 472.0
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after the 2 or 3 dose primary vaccination series

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.

The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=79 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=81 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=77 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=87 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:4, baseline (n=69,80,38,79)
3 percentages of subjects
Interval 0.0 to 9.0
—
6 percentages of subjects
Interval 2.0 to 14.0
4 percentages of subjects
Interval 1.0 to 12.0
0 percentages of subjects
Interval 0.0 to 5.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:8, baseline (n=69,80,38,79)
1 percentages of subjects
Interval 0.032 to 7.0
—
4 percentages of subjects
Interval 1.0 to 12.0
3 percentages of subjects
Interval 0.0 to 10.0
0 percentages of subjects
Interval 0.0 to 5.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79)
58 percentages of subjects
Interval 47.0 to 69.0
—
88 percentages of subjects
Interval 78.0 to 95.0
54 percentages of subjects
Interval 42.0 to 67.0
76 percentages of subjects
Interval 65.0 to 85.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:4, baseline (n=79,86,40,74)
15 percentages of subjects
Interval 8.0 to 25.0
—
18 percentages of subjects
Interval 10.0 to 28.0
13 percentages of subjects
Interval 6.0 to 23.0
15 percentages of subjects
Interval 8.0 to 24.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:8, baseline (n=79,86,40,74)
15 percentages of subjects
Interval 8.0 to 25.0
—
9 percentages of subjects
Interval 4.0 to 17.0
9 percentages of subjects
Interval 4.0 to 18.0
5 percentages of subjects
Interval 1.0 to 11.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74)
91 percentages of subjects
Interval 81.0 to 96.0
—
97 percentages of subjects
Interval 90.0 to 100.0
92 percentages of subjects
Interval 83.0 to 97.0
99 percentages of subjects
Interval 93.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:8, baseline (n=69,78,73,74)
19 percentages of subjects
Interval 11.0 to 30.0
—
46 percentages of subjects
Interval 34.0 to 59.0
37 percentages of subjects
Interval 26.0 to 49.0
28 percentages of subjects
Interval 19.0 to 40.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79)
66 percentages of subjects
Interval 54.0 to 76.0
—
93 percentages of subjects
Interval 84.0 to 98.0
60 percentages of subjects
Interval 48.0 to 72.0
81 percentages of subjects
Interval 71.0 to 89.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74)
91 percentages of subjects
Interval 81.0 to 96.0
—
96 percentages of subjects
Interval 89.0 to 99.0
84 percentages of subjects
Interval 74.0 to 92.0
98 percentages of subjects
Interval 92.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74)
85 percentages of subjects
Interval 75.0 to 92.0
—
92 percentages of subjects
Interval 84.0 to 97.0
83 percentages of subjects
Interval 73.0 to 91.0
98 percentages of subjects
Interval 92.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:4, baseline (n=69,78,73,74)
24 percentages of subjects
Interval 15.0 to 36.0
—
54 percentages of subjects
Interval 41.0 to 66.0
45 percentages of subjects
Interval 34.0 to 57.0
31 percentages of subjects
Interval 21.0 to 42.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74)
85 percentages of subjects
Interval 75.0 to 92.0
—
88 percentages of subjects
Interval 78.0 to 95.0
84 percentages of subjects
Interval 73.0 to 91.0
96 percentages of subjects
Interval 89.0 to 99.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74)
9 percentages of subjects
Interval 4.0 to 19.0
—
21 percentages of subjects
Interval 13.0 to 31.0
18 percentages of subjects
Interval 10.0 to 29.0
17 percentages of subjects
Interval 10.0 to 27.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74)
86 percentages of subjects
Interval 77.0 to 93.0
—
94 percentages of subjects
Interval 86.0 to 98.0
84 percentages of subjects
Interval 74.0 to 92.0
98 percentages of subjects
Interval 92.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74)
4 percentages of subjects
Interval 1.0 to 11.0
—
14 percentages of subjects
Interval 7.0 to 23.0
7 percentages of subjects
Interval 2.0 to 15.0
11 percentages of subjects
Interval 6.0 to 20.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74)
80 percentages of subjects
Interval 69.0 to 88.0
—
93 percentages of subjects
Interval 85.0 to 97.0
76 percentages of subjects
Interval 65.0 to 85.0
89 percentages of subjects
Interval 80.0 to 94.0
—
—
—
—
—

SECONDARY outcome

Timeframe: at 12 months of age and 1 month after PS challenge

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.

The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=44 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=42 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:4, at 12 months of age (n=44,40)
—
—
27 percentages of subjects
Interval 15.0 to 43.0
—
8 percentages of subjects
Interval 2.0 to 20.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40)
—
—
89 percentages of subjects
Interval 75.0 to 96.0
—
78 percentages of subjects
Interval 62.0 to 89.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:8, at 12 months of age (n=44,40)
—
—
23 percentages of subjects
Interval 11.0 to 38.0
—
5 percentages of subjects
Interval 1.0 to 17.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40)
—
—
86 percentages of subjects
Interval 73.0 to 95.0
—
78 percentages of subjects
Interval 62.0 to 89.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:4, at 12 months of age (n=43,41)
—
—
74 percentages of subjects
Interval 59.0 to 86.0
—
44 percentages of subjects
Interval 28.0 to 60.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41)
—
—
95 percentages of subjects
Interval 84.0 to 99.0
—
95 percentages of subjects
Interval 83.0 to 99.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:8, at 12 months of age (n=43,41)
—
—
65 percentages of subjects
Interval 49.0 to 79.0
—
39 percentages of subjects
Interval 24.0 to 55.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41)
—
—
91 percentages of subjects
Interval 78.0 to 97.0
—
93 percentages of subjects
Interval 80.0 to 98.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:4, at 12 months of age (n=40,41)
—
—
83 percentages of subjects
Interval 67.0 to 93.0
—
59 percentages of subjects
Interval 42.0 to 74.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41)
—
—
98 percentages of subjects
Interval 87.0 to 100.0
—
98 percentages of subjects
Interval 87.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:8, at 12 months of age (n=40,41)
—
—
73 percentages of subjects
Interval 56.0 to 85.0
—
51 percentages of subjects
Interval 35.0 to 67.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41)
—
—
95 percentages of subjects
Interval 83.0 to 99.0
—
98 percentages of subjects
Interval 87.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42)
—
—
89 percentages of subjects
Interval 75.0 to 96.0
—
55 percentages of subjects
Interval 39.0 to 70.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42)
—
—
98 percentages of subjects
Interval 88.0 to 100.0
—
98 percentages of subjects
Interval 87.0 to 100.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42)
—
—
77 percentages of subjects
Interval 62.0 to 89.0
—
50 percentages of subjects
Interval 34.0 to 66.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42)
—
—
98 percentages of subjects
Interval 88.0 to 100.0
—
98 percentages of subjects
Interval 87.0 to 100.0
—
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after the 2 or 3 dose primary vaccination series

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.

To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=73 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=72 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=70 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=70 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=77 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
n=73 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72)
93 percentages of subjects
Interval 83.0 to 98.0
87 percentages of subjects
Interval 77.0 to 94.0
75 percentages of subjects
Interval 64.0 to 85.0
70 percentages of subjects
Interval 58.0 to 80.0
79 percentages of subjects
Interval 68.0 to 88.0
71 percentages of subjects
Interval 59.0 to 81.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72)
100 percentages of subjects
Interval 95.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
99 percentages of subjects
Interval 92.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72)
18 percentages of subjects
Interval 10.0 to 29.0
19 percentages of subjects
Interval 10.0 to 30.0
17 percentages of subjects
Interval 9.0 to 28.0
3 percentages of subjects
Interval 0.0 to 10.0
14 percentages of subjects
Interval 7.0 to 24.0
15 percentages of subjects
Interval 8.0 to 26.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72)
97 percentages of subjects
Interval 90.0 to 100.0
96 percentages of subjects
Interval 88.0 to 99.0
96 percentages of subjects
Interval 88.0 to 99.0
100 percentages of subjects
Interval 95.0 to 100.0
97 percentages of subjects
Interval 90.0 to 100.0
100 percentages of subjects
Interval 95.0 to 100.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73)
25 percentages of subjects
Interval 15.0 to 36.0
49 percentages of subjects
Interval 37.0 to 61.0
36 percentages of subjects
Interval 25.0 to 48.0
17 percentages of subjects
Interval 9.0 to 28.0
42 percentages of subjects
Interval 30.0 to 53.0
37 percentages of subjects
Interval 26.0 to 49.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73)
97 percentages of subjects
Interval 90.0 to 100.0
97 percentages of subjects
Interval 90.0 to 100.0
74 percentages of subjects
Interval 62.0 to 84.0
67 percentages of subjects
Interval 54.0 to 78.0
95 percentages of subjects
Interval 87.0 to 99.0
100 percentages of subjects
Interval 95.0 to 100.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73)
7 percentages of subjects
Interval 2.0 to 15.0
17 percentages of subjects
Interval 9.0 to 27.0
10 percentages of subjects
Interval 4.0 to 20.0
3 percentages of subjects
Interval 0.0 to 10.0
17 percentages of subjects
Interval 9.0 to 27.0
11 percentages of subjects
Interval 5.0 to 20.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73)
82 percentages of subjects
Interval 71.0 to 90.0
82 percentages of subjects
Interval 71.0 to 90.0
33 percentages of subjects
Interval 22.0 to 45.0
35 percentages of subjects
Interval 24.0 to 47.0
86 percentages of subjects
Interval 76.0 to 93.0
86 percentages of subjects
Interval 76.0 to 93.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67)
NA percentages of subjects
not performed due to insufficient sera
NA percentages of subjects
not performed due to insufficient sera
23 percentages of subjects
Interval 14.0 to 35.0
11 percentages of subjects
Interval 4.0 to 21.0
NA percentages of subjects
not performed due to insufficient sera
22 percentages of subjects
Interval 13.0 to 34.0
—
—
—
—
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67)
NA percentages of subjects
not performed due to insufficient sera
NA percentages of subjects
not performed due to insufficient sera
85 percentages of subjects
Interval 74.0 to 92.0
92 percentages of subjects
Interval 83.0 to 97.0
NA percentages of subjects
not performed due to insufficient sera
97 percentages of subjects
Interval 90.0 to 100.0
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after the 2 or 3 dose primary vaccination series

Population: The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.

To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=73 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=72 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=70 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=70 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=77 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
n=73 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Diphtheria - baseline (n=69,71,70,67,69,72)
0.031 titers
Interval 0.024 to 0.042
0.032 titers
Interval 0.024 to 0.042
0.035 titers
Interval 0.026 to 0.047
0.027 titers
Interval 0.02 to 0.035
0.04 titers
Interval 0.03 to 0.053
0.016 titers
Interval 0.012 to 0.021
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Tetanus - baseline (n=69,71,70,67,69,72)
0.28 titers
Interval 0.22 to 0.37
0.25 titers
Interval 0.19 to 0.32
0.32 titers
Interval 0.24 to 0.41
0.23 titers
Interval 0.18 to 0.29
0.31 titers
Interval 0.24 to 0.4
0.18 titers
Interval 0.14 to 0.23
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72)
0.6 titers
Interval 0.48 to 0.73
0.97 titers
Interval 0.79 to 1.19
0.7 titers
Interval 0.57 to 0.87
1.4 titers
Interval 1.14 to 1.72
0.92 titers
Interval 0.75 to 1.13
0.68 titers
Interval 0.55 to 0.83
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72)
1.06 titers
Interval 0.84 to 1.32
0.98 titers
Interval 0.78 to 1.22
1.02 titers
Interval 0.81 to 1.29
1.72 titers
Interval 1.38 to 2.14
1.02 titers
Interval 0.82 to 1.28
1.49 titers
Interval 1.19 to 1.87
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Hib - baseline (n=70,77,69,73,72,73)
0.089 titers
Interval 0.063 to 0.12
0.15 titers
Interval 0.11 to 0.21
0.078 titers
Interval 0.056 to 0.11
0.11 titers
Interval 0.078 to 0.15
0.15 titers
Interval 0.11 to 0.21
0.064 titers
Interval 0.045 to 0.09
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Hib - 1 m after 1st vacc (n=70,77,69,73,72,73)
0.47 titers
Interval 0.32 to 0.7
5.67 titers
Interval 3.89 to 8.28
4.63 titers
Interval 3.14 to 6.83
4.53 titers
Interval 3.07 to 6.68
4.55 titers
Interval 3.08 to 6.72
0.42 titers
Interval 0.28 to 0.63
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Hepatitis B - baseline (n=65,na,66,na,na,67)
5.79 titers
Interval 4.15 to 8.09
NA titers
not performed due to insufficient sera
NA titers
not performed due to insufficient sera
5.9 titers
Interval 4.25 to 8.2
NA titers
not performed due to insufficient sera
4.21 titers
Interval 3.03 to 5.87
—
—
—
—
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67)
69 titers
Interval 47.0 to 102.0
NA titers
not performed due to insufficient sera
NA titers
not performed due to insufficient sera
378 titers
Interval 258.0 to 554.0
NA titers
not performed due to insufficient sera
133 titers
Interval 90.0 to 195.0
—
—
—
—

SECONDARY outcome

Timeframe: Baseline and 1 month after second vaccination

Population: The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population after second vaccination.

The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=79 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=85 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=40 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=74 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=77 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)
hSBA ≥1:8, baseline
5 percentages of subjects
Interval 1.0 to 12.0
11 percentages of subjects
Interval 5.0 to 19.0
10 percentages of subjects
Interval 3.0 to 24.0
15 percentages of subjects
Interval 8.0 to 25.0
9 percentages of subjects
Interval 4.0 to 18.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)
hSBA ≥1:4, baseline
20 percentages of subjects
Interval 12.0 to 31.0
20 percentages of subjects
Interval 12.0 to 30.0
23 percentages of subjects
Interval 11.0 to 38.0
15 percentages of subjects
Interval 8.0 to 25.0
13 percentages of subjects
Interval 6.0 to 23.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)
hSBA ≥1:4, 1 month after second vaccination
86 percentages of subjects
Interval 76.0 to 93.0
93 percentages of subjects
Interval 85.0 to 97.0
98 percentages of subjects
Interval 87.0 to 100.0
91 percentages of subjects
Interval 81.0 to 96.0
84 percentages of subjects
Interval 74.0 to 92.0
—
—
—
—
—
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)
hSBA ≥1:8, 1 month after second vaccination
82 percentages of subjects
Interval 72.0 to 90.0
89 percentages of subjects
Interval 81.0 to 95.0
98 percentages of subjects
Interval 87.0 to 100.0
85 percentages of subjects
Interval 75.0 to 92.0
83 percentages of subjects
Interval 73.0 to 91.0
—
—
—
—
—

SECONDARY outcome

Timeframe: 7 days after each vaccination

Population: Analysis was done on safety dataset "n" population - subjects who received at least one study dose and had Post baseline safety data.

Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=98 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=98 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=90 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=45 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=90 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
n=90 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=90 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Tenderness
46 subjects
32 subjects
40 subjects
18 subjects
31 subjects
41 subjects
35 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Persistent Crying
15 subjects
4 subjects
7 subjects
6 subjects
7 subjects
5 subjects
4 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Analgesics/Antipyretics
61 subjects
46 subjects
43 subjects
18 subjects
35 subjects
36 subjects
45 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Erythema
73 subjects
67 subjects
69 subjects
34 subjects
64 subjects
78 subjects
66 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Induration
36 subjects
18 subjects
21 subjects
12 subjects
24 subjects
40 subjects
24 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Eating habit Change
35 subjects
27 subjects
28 subjects
9 subjects
25 subjects
21 subjects
20 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Sleepiness
64 subjects
62 subjects
56 subjects
25 subjects
49 subjects
45 subjects
52 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Irritability
80 subjects
70 subjects
63 subjects
31 subjects
71 subjects
61 subjects
73 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Vomiting
23 subjects
15 subjects
19 subjects
9 subjects
26 subjects
14 subjects
11 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Diarrhea
30 subjects
22 subjects
29 subjects
12 subjects
27 subjects
18 subjects
16 subjects
—
—
—
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Fever (≥38°C)
14 subjects
7 subjects
7 subjects
1 subjects
4 subjects
5 subjects
5 subjects
—
—
—

SECONDARY outcome

Timeframe: 7 days after vaccination at 12 months of age

Population: Analysis was done on safety dataset "n" population.

The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.

Outcome measures

Outcome measures
Measure
CA24+ (MenACWY Ad+ at 2, 4 m)
n=48 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=48 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
n=90 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
UK24- (MenACWY Ad- at 2, 4 m)
n=45 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=90 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
n=47 Participants
Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m)
n=48 Participants
Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2, 4 m)
n=90 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
n=44 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
CA24- (MenACWY Ad- at 2, 4 m) - PS
n=43 Participants
Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Tenderness
0 subjects
10 subjects
7 subjects
10 subjects
11 subjects
7 subjects
10 subjects
10 subjects
7 subjects
12 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Erythema
0 subjects
21 subjects
62 subjects
36 subjects
58 subjects
27 subjects
30 subjects
66 subjects
21 subjects
26 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Induration
0 subjects
12 subjects
21 subjects
18 subjects
32 subjects
9 subjects
9 subjects
36 subjects
10 subjects
15 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Eating habit change
10 subjects
12 subjects
11 subjects
5 subjects
16 subjects
6 subjects
10 subjects
13 subjects
10 subjects
8 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Sleepiness
10 subjects
8 subjects
11 subjects
9 subjects
14 subjects
7 subjects
13 subjects
16 subjects
9 subjects
7 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Persistent crying
3 subjects
3 subjects
0 subjects
3 subjects
4 subjects
0 subjects
2 subjects
4 subjects
5 subjects
0 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Irritability
24 subjects
23 subjects
26 subjects
20 subjects
32 subjects
19 subjects
24 subjects
28 subjects
17 subjects
20 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Vomiting
2 subjects
7 subjects
4 subjects
4 subjects
6 subjects
0 subjects
4 subjects
8 subjects
5 subjects
4 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Diarrhea
4 subjects
7 subjects
9 subjects
4 subjects
9 subjects
6 subjects
5 subjects
9 subjects
3 subjects
4 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Fever (≥38°C)
3 subjects
6 subjects
3 subjects
2 subjects
7 subjects
1 subjects
8 subjects
14 subjects
4 subjects
1 subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
Analgesics/Antipyretics
13 subjects
15 subjects
14 subjects
12 subjects
21 subjects
8 subjects
17 subjects
22 subjects
14 subjects
11 subjects

Adverse Events

UK234+ (MenACWY Ad+ at 2,3,4 m)

Serious events: 20 serious events
Other events: 90 other events
Deaths: 0 deaths

UK24+ (MenACWY Ad+ at 2,4 m)

Serious events: 17 serious events
Other events: 89 other events
Deaths: 0 deaths

UKMenC (Menjugate at 2,4m)

Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths

CA246+ (MenACWY Ad+ at 2,4,6m)

Serious events: 9 serious events
Other events: 97 other events
Deaths: 0 deaths

CA24+ (MenACWY Ad+ at 2,4m)

Serious events: 4 serious events
Other events: 97 other events
Deaths: 0 deaths

UK24- (MenACWY Ad- at 2,4m)

Serious events: 10 serious events
Other events: 90 other events
Deaths: 0 deaths

CA24- (MenACWY Ad- at 2,4m)

Serious events: 7 serious events
Other events: 89 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
UK234+ (MenACWY Ad+ at 2,3,4 m)
n=90 participants at risk
Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
UK24+ (MenACWY Ad+ at 2,4 m)
n=90 participants at risk
Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
UKMenC (Menjugate at 2,4m)
n=45 participants at risk
Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
CA246+ (MenACWY Ad+ at 2,4,6m)
n=98 participants at risk
Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24+ (MenACWY Ad+ at 2,4m)
n=98 participants at risk
Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2,4m)
n=90 participants at risk
Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
CA24- (MenACWY Ad- at 2,4m)
n=90 participants at risk
Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Infections and infestations
CROUP INFECTIOUS
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
GASTROENTERITIS
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
GASTROENTERITIS VIRAL
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
INFECTED CYST
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
INFLUENZA
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
PNEUMONIA
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
SALMONELLOSIS
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
VARICELLA
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
VIRAL INFECTION
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
VIRAL RASH
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
BURNS FIRST DEGREE
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
FEMUR FRACTURE
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
HEAD INJURY
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
INJURY
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
LIMB CRUSHING INJURY
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Injury, poisoning and procedural complications
TRAUMATIC FRACTURE
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Nervous system disorders
CONVULSION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Nervous system disorders
FEBRILE CONVULSION
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Renal and urinary disorders
URINARY RETENTION
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Respiratory, thoracic and mediastinal disorders
ASTHMA
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Respiratory, thoracic and mediastinal disorders
WHEEZING
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
PETECHIAE
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
RASH
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Surgical and medical procedures
ACROCHORDON EXCISION
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Surgical and medical procedures
CIRCUMCISION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Surgical and medical procedures
HYDROCELE OPERATION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Surgical and medical procedures
INGUINAL HERNIA REPAIR
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.0%
2/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Surgical and medical procedures
TENDON SHEATH INCISION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Blood and lymphatic system disorders
IDIOPATHIC THROMBOCYTOPENIC PURPURA
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Congenital, familial and genetic disorders
CONGENITAL MEGACOLON
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Congenital, familial and genetic disorders
HYPOSPADIAS
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Congenital, familial and genetic disorders
PLAGIOCEPHALY
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Gastrointestinal disorders
INGUINAL HERNIA
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
VOMITING
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
CYST
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
DEVELOPMENTAL DELAY
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Immune system disorders
FOOD ALLERGY
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
ARTHRITIS BACTERIAL
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
BRONCHIOLITIS
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.0%
2/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.

Other adverse events

Other adverse events
Measure
UK234+ (MenACWY Ad+ at 2,3,4 m)
n=90 participants at risk
Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
UK24+ (MenACWY Ad+ at 2,4 m)
n=90 participants at risk
Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
UKMenC (Menjugate at 2,4m)
n=45 participants at risk
Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
CA246+ (MenACWY Ad+ at 2,4,6m)
n=98 participants at risk
Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
CA24+ (MenACWY Ad+ at 2,4m)
n=98 participants at risk
Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
UK24- (MenACWY Ad- at 2,4m)
n=90 participants at risk
Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
CA24- (MenACWY Ad- at 2,4m)
n=90 participants at risk
Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Eye disorders
CONJUNCTIVITIS
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
10.0%
9/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.7%
3/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.1%
3/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
13.3%
12/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Gastrointestinal disorders
CONSTIPATION
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.4%
2/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
8.2%
8/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.1%
6/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Gastrointestinal disorders
DIARRHOEA
45.6%
41/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
44.4%
40/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
40.0%
18/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
37.8%
37/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
34.7%
34/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
40.0%
36/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
27.8%
25/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Gastrointestinal disorders
VOMITING
26.7%
24/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
41.1%
37/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
28.9%
13/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
29.6%
29/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
23.5%
23/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
31.1%
28/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
22.2%
20/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
CRYING
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
12.2%
11/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
17.8%
8/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
19.4%
19/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
8.2%
8/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
15.6%
14/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
10.0%
9/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
INJECTION SITE ERYTHEMA
87.8%
79/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
87.8%
79/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
88.9%
40/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
74.5%
73/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
79.6%
78/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
93.3%
84/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
75.6%
68/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
INJECTION SITE INDURATION
43.3%
39/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
47.8%
43/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
55.6%
25/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
42.9%
42/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
25.5%
25/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
65.6%
59/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
40.0%
36/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
INJECTION SITE PAIN
46.7%
42/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
43.3%
39/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
51.1%
23/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
51.0%
50/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
41.8%
41/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
50.0%
45/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
50.0%
45/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
IRRITABILITY
76.7%
69/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
91.1%
82/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
86.7%
39/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
86.7%
85/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
86.7%
85/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
85.6%
77/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
91.1%
82/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
General disorders
PYREXIA
12.2%
11/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
14.4%
13/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.7%
3/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
30.6%
30/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
22.4%
22/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
21.1%
19/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
23.3%
21/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
BRONCHIOLITIS
8.9%
8/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.1%
3/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.1%
5/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
CROUP INFECTIOUS
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.1%
3/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.1%
5/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
10.0%
9/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
8.9%
8/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.0%
2/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
10.0%
9/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
NASOPHARYNGITIS
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
13.3%
13/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
14.3%
14/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
15.6%
14/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
ORAL CANDIDIASIS
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.0%
2/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.1%
5/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
OTITIS MEDIA
6.7%
6/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
9.2%
9/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
7.1%
7/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
13.3%
12/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
RHINITIS
33.3%
30/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
37.8%
34/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
33.3%
15/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.0%
2/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
43.3%
39/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
11.1%
10/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
17.8%
8/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
21.4%
21/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
25.5%
25/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
22.2%
20/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Infections and infestations
VIRAL INFECTION
6.7%
6/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Nervous system disorders
SOMNOLENCE
64.4%
58/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
63.3%
57/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
64.4%
29/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
69.4%
68/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
71.4%
70/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
63.3%
57/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
70.0%
63/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Psychiatric disorders
EATING DISORDER
37.8%
34/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
46.7%
42/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
37.8%
17/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
45.9%
45/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
42.9%
42/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
41.1%
37/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
42.2%
38/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Respiratory, thoracic and mediastinal disorders
COUGH
11.1%
10/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
20.0%
9/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.1%
3/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.1%
6/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
17.8%
16/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.1%
3/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.1%
6/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.1%
5/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.0%
2/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER
6.7%
6/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.1%
6/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
7.1%
7/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
DRY SKIN
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
1/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.1%
4/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.6%
5/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
ECZEMA
8.9%
8/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
14.4%
13/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
11.1%
5/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
15.3%
15/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
8.2%
8/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
8.9%
8/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
7.8%
7/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
RASH
3.3%
3/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
4.4%
4/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
6.7%
3/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.1%
5/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
3.1%
3/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
2.2%
2/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
8.9%
8/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
Skin and subcutaneous tissue disorders
RASH PAPULAR
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/45 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
5.1%
5/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.0%
1/98 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
0.00%
0/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
1.1%
1/90 • All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.

Additional Information

Posting Director

Novartis Vaccine and Diagnostics S.r.l

Results disclosure agreements

  • Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single site are postponed until the publication of the pool data (i.e., data from all sites) in the clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER