Trial Outcomes & Findings for Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations (NCT NCT01359449)
NCT ID: NCT01359449
Last Updated: 2016-08-19
Results Overview
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
123 participants
Primary outcome timeframe
28 days post-vaccination
Results posted on
2016-08-19
Participant Flow
Study participants were enrolled from 19 May 2011 through 14 September 2011 in one clinic site in Canada.
A total of 123 participants that met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Menactra® Vaccine Group
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Overall Study
STARTED
|
61
|
62
|
|
Overall Study
COMPLETED
|
57
|
58
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
| Measure |
Menactra® Vaccine Group
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations
Baseline characteristics by cohort
| Measure |
Menactra® Vaccine Group
n=61 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
Total
n=123 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
12.4 Months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
12.4 Months
STANDARD_DEVIATION 0.3 • n=7 Participants
|
12.4 Months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Outcome measures
| Measure |
Menactra® Vaccine Group
n=55 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 13 months, N = 0, 60)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
71.0 Titers
Interval 39.3 to 128.0
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 19 months, N = 51, 58)
|
957 Titers
Interval 594.0 to 1540.0
|
11.0 Titers
Interval 6.75 to 18.1
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 13 months, N = 0, 60)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
31.3 Titers
Interval 19.6 to 50.0
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 19 months, N = 51, 58)
|
719 Titers
Interval 553.0 to 935.0
|
67.1 Titers
Interval 38.4 to 117.0
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 13 months, N = 0, 60)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
5.28 Titers
Interval 4.13 to 6.74
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 19 months, N = 51, 58)
|
970 Titers
Interval 686.0 to 1371.0
|
7.36 Titers
Interval 5.24 to 10.3
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age13 months, N = 0, 60)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
4.34 Titers
Interval 3.69 to 5.1
|
|
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 19 months, N = 51, 58)
|
1740 Titers
Interval 1301.0 to 2327.0
|
4.35 Titers
Interval 3.76 to 5.03
|
PRIMARY outcome
Timeframe: 28 days post-vaccinationPopulation: Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Outcome measures
| Measure |
Menactra® Vaccine Group
n=55 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 19 months; N = 51, 58)
|
49 Participants
|
15 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 13 months; N = 0, 60)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
36 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 19 months; N = 51, 58)
|
50 Participants
|
11 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 13 months; N = 0, 60)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 19 months; N = 51, 58)
|
51 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 13 months; N = 0, 60)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
40 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 19 months; N = 51, 58)
|
51 Participants
|
39 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 13 months; N = 0, 60)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
5 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population
Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=55 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 13 months, N = 0, 50)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
17.4 Titers
Interval 11.6 to 26.1
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 19 months, N = 49, 53)
|
219 Titers
Interval 152.0 to 315.0
|
6.93 Titers
Interval 4.53 to 10.6
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 13 months, N = 0, 45)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
2.00 Titers
Interval 2.0 to 2.0
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 19 months, N = 49, 53)
|
299 Titers
Interval 222.0 to 403.0
|
2.14 Titers
Interval 1.98 to 2.31
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 13 months, N = 0, 44)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
2.23 Titers
Interval 2.04 to 2.44
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 19 months, N = 49, 48)
|
71.7 Titers
Interval 48.2 to 107.0
|
2.21 Titers
Interval 2.0 to 2.45
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 13 months, N = 0, 45)
|
NA Titers
Data not determined for this group at this time point as per protocol.
|
2.06 Titers
Interval 1.97 to 2.15
|
|
Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 19 months, N = 49, 50)
|
207 Titers
Interval 146.0 to 295.0
|
2.17 Titers
Interval 2.01 to 2.34
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population
Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination
Outcome measures
| Measure |
Menactra® Vaccine Group
n=55 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 13 months; N = 0, 45)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 19 months; N = 49, 50)
|
48 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 13 months; N = 0, 44)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup A (at age 19 months; N = 49, 48)
|
48 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 13 months; N = 0, 50)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
39 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup C (at age 19 months; N = 49, 53)
|
49 Participants
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup Y (at age 19 months; N = 49, 53)
|
49 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Serogroup W-135 (at age 13 months; N = 0, 45)
|
NA Participants
Data not determined for this group at this time point as per protocol.
|
0 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.
Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group
Outcome measures
| Measure |
Menactra® Vaccine Group
n=51 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Diphtheria (at age 18 months; N = 46, 0)
|
0.420 Titers
Interval 0.283 to 0.622
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Diphtheria (at age 19 months; N = 46, 0)
|
7.81 Titers
Interval 6.03 to 10.1
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
PRP (at age 19 months; N = 46, 0)
|
46.3 Titers
Interval 32.2 to 66.4
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Polio Type 2 (at age 18 months; N = 39, 0)
|
203 Titers
Interval 127.0 to 324.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Polio Type 2 (at age 19 months; N = 46, 0)
|
6889 Titers
Interval 5250.0 to 9039.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Pertussis Toxoid (at age 18 months; N = 45, 0)
|
8.61 Titers
Interval 6.39 to 11.6
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Pertussis Toxoid (at age 19 months; N = 47, 0)
|
162 Titers
Interval 132.0 to 199.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Filamentous hemagglutinin (age 18 months; N=45, 0)
|
19.9 Titers
Interval 14.1 to 28.2
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Filamentous hemagglutinin (age 19 months; N=47, 0)
|
239 Titers
Interval 182.0 to 315.0
|
NA Titers
Participants in this group did not receive Pediacel vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Pertactin (at age 18 months; N = 44, 0)
|
8.45 Titers
Interval 6.46 to 11.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Fimbriae types 2 and 3 (age 19 months; N = 45, 0)
|
622 Titers
Interval 425.0 to 911.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Tetanus (at age 18 months; N = 44, 0)
|
0.485 Titers
Interval 0.365 to 0.644
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Tetanus (at age 19 months; N = 47, 0)
|
8.71 Titers
Interval 7.02 to 10.8
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
PRP (at age 18 months; N = 44, 0)
|
0.500 Titers
Interval 0.306 to 0.818
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Polio Type 1 (at age 18 months; N = 45, 0)
|
138 Titers
Interval 95.2 to 201.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Polio Type 1 (at age 19 months; N = 46, 0)
|
4552 Titers
Interval 3436.0 to 6029.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Polio Type 3 (at age 18 months; N = 38, 0)
|
133 Titers
Interval 84.2 to 209.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Polio Type 3 (at age 19 months; N = 45, 0)
|
5322 Titers
Interval 3705.0 to 7645.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Pertactin (at age 19 months; N = 45, 0)
|
123 Titers
Interval 90.7 to 165.0
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Fimbriae types 2 and 3 (age 18 months; N = 45, 0)
|
35.7 Titers
Interval 26.4 to 48.3
|
NA Titers
Participants in this group did not receive Pediacel® vaccine in this study.
|
SECONDARY outcome
Timeframe: 28 days post-vaccinationPopulation: Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group
Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers \< 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate
Outcome measures
| Measure |
Menactra® Vaccine Group
n=51 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Filamentous hemagglutinin (N = 44, 0)
|
43 Participants
|
NA Participants
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Pertactin (N = 41, 0)
|
38 Participants
|
NA Participants
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Fimbriae types 2 and 3 (N = 42, 0)
|
42 Participants
|
NA Participants
Participants in this group did not receive Pediacel® vaccine in this study.
|
|
Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Pertussis toxoid (N = 44, 0)
|
44 Participants
|
NA Participants
Participants in this group did not receive Pediacel® vaccine in this study.
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population
Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - \> 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=60 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 injection site Tenderness
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any injection site Erythema
|
26 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any injection site Swelling
|
9 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any Fever
|
30 Participants
|
18 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 Fever
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any Vomiting
|
5 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 Vomiting
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 Crying abnormal
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any Drowsiness
|
22 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any injection site Tenderness
|
21 Participants
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 injection site Erythema
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 injection site Swelling
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any Crying abnormal
|
25 Participants
|
22 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any Appetite lost
|
28 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 Appetite lost
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Any Irritability
|
43 Participants
|
40 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Grade 3 Irritability
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population
Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - \> 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.
Outcome measures
| Measure |
Menactra® Vaccine Group
n=60 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any Vomiting
|
6 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 Drowsiness
|
1 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any Irritability
|
40 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any injection site Tenderness
|
30 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 injection site Tenderness
|
2 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any injection site Erythema
|
19 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 injection site Erythema
|
1 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any injection site Swelling
|
11 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 injection site Swelling
|
0 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any Fever
|
21 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 Fever
|
3 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 Vomiting
|
1 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any Crying abnormal
|
25 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 Crying abnormal
|
1 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any Drowsiness
|
20 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Any Appetite lost
|
32 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 Appetite lost
|
1 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Grade 3 Irritability
|
2 Participants
|
NA Participants
Interval 0.0 to 0.0
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population
Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability
Outcome measures
| Measure |
Menactra® Vaccine Group
n=60 Participants
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 Participants
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any Fever
|
44 Participants
|
18 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any Appetite lost
|
45 Participants
|
24 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any injection site Tenderness
|
36 Participants
|
21 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any injection site Erythema
|
32 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any injection site Swelling
|
18 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any Vomiting
|
10 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any Crying abnormal
|
31 Participants
|
22 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any Drowsiness
|
31 Participants
|
12 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Any Irritability
|
50 Participants
|
40 Participants
Interval 0.0 to 0.0
|
Adverse Events
Menactra® Vaccine Group
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
Menjugate® Vaccine Group
Serious events: 2 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra® Vaccine Group
n=61 participants at risk
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 participants at risk
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/61 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
1.6%
1/62 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Musculoskeletal and connective tissue disorders
Rickets
|
0.00%
0/61 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
1.6%
1/62 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Nervous system disorders
Febrile convulsion
|
1.6%
1/61 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
Other adverse events
| Measure |
Menactra® Vaccine Group
n=61 participants at risk
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
|
Menjugate® Vaccine Group
n=62 participants at risk
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.2%
5/61 • Number of events 6 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
9.7%
6/62 • Number of events 6 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Gastrointestinal disorders
Teething
|
21.3%
13/61 • Number of events 13 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
14.5%
9/62 • Number of events 10 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Gastrointestinal disorders
Vomiting
|
16.4%
10/61 • Number of events 10 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
11.3%
7/62 • Number of events 7 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
General disorders
Irritability
|
6.6%
4/61 • Number of events 6 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
General disorders
Pyrexia
|
49.2%
30/61 • Number of events 30 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
29.0%
18/62 • Number of events 18 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Psychiatric disorders
Irritability
|
82.0%
50/61 • Number of events 50 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
64.5%
40/62 • Number of events 40 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
General disorders
Injection site Tenderness
|
59.0%
36/61 • Number of events 36 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
33.9%
21/62 • Number of events 21 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
General disorders
Injection site Erythema
|
52.5%
32/61 • Number of events 32 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
37.1%
23/62 • Number of events 23 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
General disorders
Injection site Swelling
|
29.5%
18/61 • Number of events 18 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
12.9%
8/62 • Number of events 8 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Nervous system disorders
Somnolence
|
50.8%
31/61 • Number of events 31 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
19.4%
12/62 • Number of events 12 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Metabolism and nutrition disorders
Anorexia
|
73.8%
45/61 • Number of events 45 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
38.7%
24/62 • Number of events 24 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Psychiatric disorders
Crying
|
50.8%
31/61 • Number of events 31 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
35.5%
22/62 • Number of events 22 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Infections and infestations
Nasopharyngitis
|
23.0%
14/61 • Number of events 19 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
12.9%
8/62 • Number of events 8 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Infections and infestations
Otitis media
|
11.5%
7/61 • Number of events 9 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Infections and infestations
Roseola
|
4.9%
3/61 • Number of events 3 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Infections and infestations
Sinusitis
|
4.9%
3/61 • Number of events 3 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
4/61 • Number of events 4 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
1.6%
1/62 • Number of events 2 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.2%
5/61 • Number of events 5 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.6%
4/61 • Number of events 5 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
1.6%
1/62 • Number of events 1 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Skin and subcutaneous tissue disorders
Rash maculo papular
|
11.5%
7/61 • Number of events 7 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
6.5%
4/62 • Number of events 4 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
6.6%
4/61 • Number of events 5 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
0.00%
0/62 • Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER