Trial Outcomes & Findings for Dose Comparison Study of Menactra® in US Children (NCT NCT00700635)
NCT ID: NCT00700635
Last Updated: 2016-04-14
Results Overview
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
333 participants
Primary outcome timeframe
30 days post-vaccination
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 17 June 2008 to 25 July 2008 in 13 of 15 medical centers in the US.
A total of 333 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participant milestones
| Measure |
Menactra® Group 1
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
111
|
111
|
111
|
|
Overall Study
COMPLETED
|
100
|
103
|
110
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
1
|
Reasons for withdrawal
| Measure |
Menactra® Group 1
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
|
Overall Study
Protocol Violation
|
2
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
1
|
Baseline Characteristics
Dose Comparison Study of Menactra® in US Children
Baseline characteristics by cohort
| Measure |
Menactra® Group 1
n=111 Participants
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=111 Participants
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=111 Participants
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
111 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
333 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
Age Continuous
|
2.46 Years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
4.46 Years
STANDARD_DEVIATION 0.5 • n=7 Participants
|
8.05 Years
STANDARD_DEVIATION 1.31 • n=5 Participants
|
4.99 Years
STANDARD_DEVIATION 2.47 • n=4 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
111 participants
n=7 Participants
|
111 participants
n=5 Participants
|
333 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days post-vaccinationPopulation: Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Outcome measures
| Measure |
Menactra® Group 1
n=82 Participants
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=89 Participants
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=108 Participants
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107]
|
59 Percentage of Participants
|
36 Percentage of Participants
|
65 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0]
|
83 Percentage of Participants
|
67 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108]
|
72 Percentage of Participants
|
51 Percentage of Participants
|
62 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0]
|
95 Percentage of Participants
|
88 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108]
|
60 Percentage of Participants
|
65 Percentage of Participants
|
71 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0]
|
100 Percentage of Participants
|
96 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108]
|
66 Percentage of Participants
|
79 Percentage of Participants
|
91 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0]
|
96 Percentage of Participants
|
96 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
SECONDARY outcome
Timeframe: 30 days post-vaccinationPopulation: Serum bactericidal assay human complement antibody titers to each of the 4 meningococcal serogroups in the vaccine were evaluated in the per-protocol population.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Outcome measures
| Measure |
Menactra® Group 1
n=82 Participants
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=89 Participants
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=108 Participants
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup A Post-dose 1 ≥ 4 [n = 82, 89, 107]
|
73 Percentage of Participants
|
58 Percentage of Participants
|
79 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup A Post-dose 2 ≥ 4 [n = 81, 89, 0]
|
94 Percentage of Participants
|
79 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup C Post-dose 1 ≥ 4 [n = 82, 89, 108]
|
78 Percentage of Participants
|
63 Percentage of Participants
|
69 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup C Post-dose 2 ≥ 4 [n = 82, 89, 0]
|
95 Percentage of Participants
|
91 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup Y Post-dose 1 ≥ 4 [n = 82, 89, 108]
|
77 Percentage of Participants
|
83 Percentage of Participants
|
83 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup Y Post-dose 2 ≥ 4 [n = 82, 89, 0]
|
100 Percentage of Participants
|
98 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup W-135 Post-dose 1 ≥ 4 [n = 82, 89, 108]
|
83 Percentage of Participants
|
89 Percentage of Participants
|
96 Percentage of Participants
|
|
Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Serogroup W-135 Post-dose 2 ≥ 4 [n = 82, 89, 0]
|
99 Percentage of Participants
|
100 Percentage of Participants
|
NA Percentage of Participants
Dose 2 vaccination was not administered to the Menactra Group 3
|
SECONDARY outcome
Timeframe: 30 days post-vaccinationPopulation: Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Outcome measures
| Measure |
Menactra® Group 1
n=82 Participants
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=89 Participants
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=108 Participants
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup A Post-dose 1 [n = 82, 89, 107]
|
9.97 Titers
Interval 7.37 to 13.5
|
5.59 Titers
Interval 4.35 to 7.18
|
12.7 Titers
Interval 9.53 to 16.8
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup A Post-dose 2 [n = 81, 89, 0]
|
24.3 Titers
Interval 17.4 to 33.9
|
13.6 Titers
Interval 9.77 to 18.9
|
NA Titers
Dose 2 vaccination was not administered to the Menactra Group 3.
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup C Post-dose 1 [n = 82, 89, 108]
|
13.4 Titers
Interval 9.76 to 18.4
|
8.99 Titers
Interval 6.41 to 12.6
|
18.5 Titers
Interval 12.1 to 28.4
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup C Post-dose 2 [n = 82, 89, 0]
|
92.8 Titers
Interval 65.5 to 132.0
|
46.1 Titers
Interval 32.7 to 65.2
|
NA Titers
Dose 2 vaccination was not administered to the Menactra Group 3.
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup Y Post-dose 1 [n = 82, 89, 108]
|
8.42 Titers
Interval 6.51 to 10.9
|
9.13 Titers
Interval 7.27 to 11.5
|
14.2 Titers
Interval 10.8 to 18.6
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup Y Post-dose 2 [n = 82, 89, 0]
|
78.4 Titers
Interval 62.4 to 98.6
|
42.0 Titers
Interval 32.1 to 55.0
|
NA Titers
Dose 2 vaccination was not administered to the Menactra Group 3.
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup W-135 Post-dose 1 [n = 82, 89, 108]
|
12.4 Titers
Interval 9.33 to 16.5
|
15.5 Titers
Interval 11.9 to 20.2
|
24.1 Titers
Interval 19.1 to 30.5
|
|
Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Serogroup W-135 Post-dose 2 [n = 82, 89, 0]
|
57.8 Titers
Interval 44.2 to 75.7
|
50.3 Titers
Interval 37.9 to 66.8
|
NA Titers
Dose 2 vaccination was not administered to the Menactra Group 3.
|
SECONDARY outcome
Timeframe: 7 days post-vaccination 1Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
Menactra® Group 1
n=111 Participants
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=111 Participants
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=111 Participants
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Pain
|
53 Percentage of Participants
|
53 Percentage of Participants
|
58 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Solicited Injection Site Reaction Post Dose 1
|
67 Percentage of Participants
|
60 Percentage of Participants
|
67 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Pain (Incapacitating)
|
1 Percentage of Participants
|
0 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Erythema
|
47 Percentage of Participants
|
27 Percentage of Participants
|
32 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Erythema (≥ 5 cm)
|
5 Percentage of Participants
|
4 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Swelling
|
23 Percentage of Participants
|
18 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Swelling (≥ 5 cm)
|
4 Percentage of Participants
|
3 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Solicited Systemic Reaction Post Dose 1
|
52 Percentage of Participants
|
43 Percentage of Participants
|
38 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Fever
|
7 Percentage of Participants
|
4 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Fever (> 39.0 ºC or > 102.2 ºF)
|
1 Percentage of Participants
|
1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Headache
|
7 Percentage of Participants
|
15 Percentage of Participants
|
23 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Headache (Prevents daily activities)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Vomiting
|
6 Percentage of Participants
|
4 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Vomiting (≥ 3 episodes per 24 hours)
|
0 Percentage of Participants
|
1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Drowsiness
|
21 Percentage of Participants
|
16 Percentage of Participants
|
14 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Drowsiness (Disabling)
|
1 Percentage of Participants
|
4 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Anorexia
|
20 Percentage of Participants
|
10 Percentage of Participants
|
7 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Anorexia (Skips ≥ 3 meals)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Irritability
|
35 Percentage of Participants
|
20 Percentage of Participants
|
11 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Irritability (>3 hours duration)
|
2 Percentage of Participants
|
4 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Arthralgia
|
7 Percentage of Participants
|
8 Percentage of Participants
|
7 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Arthralgia (Unwllling to move due to pain)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Any Diarrhea
|
17 Percentage of Participants
|
8 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Grade 3 Diarrhea (≥ 5 episodes per 24 hours)
|
2 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 7 days post-vaccination 2Population: Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Outcome measures
| Measure |
Menactra® Group 1
n=111 Participants
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=111 Participants
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Solicited Injection Site Reaction Post Dose 2
|
60 Percentage of Participants
|
64 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Pain
|
48 Percentage of Participants
|
52 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Pain (Incapacitating)
|
0 Percentage of Participants
|
1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Erythema
|
37 Percentage of Participants
|
36 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Erythema (≥ 5 cm)
|
8 Percentage of Participants
|
4 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Swelling
|
20 Percentage of Participants
|
15 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Swelling (≥ 5 cm)
|
3 Percentage of Participants
|
2 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Solicited Systemic Reaction Post Dose 2
|
53 Percentage of Participants
|
49 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Fever
|
5 Percentage of Participants
|
13 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Fever (> 39.0 ºC or > 102.2 ºF)
|
0 Percentage of Participants
|
3 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Headache
|
6 Percentage of Participants
|
14 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Headache (Prevents daily activities)
|
0 Percentage of Participants
|
1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Vomiting
|
5 Percentage of Participants
|
7 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Vomiting (≥ 3 episodes per 24 hours)
|
1 Percentage of Participants
|
2 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Drowsiness
|
19 Percentage of Participants
|
18 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Drowsiness (Disabling)
|
1 Percentage of Participants
|
2 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Anorexia
|
21 Percentage of Participants
|
17 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Anorexia (Skips ≥ 3 meals)
|
1 Percentage of Participants
|
1 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Irritability
|
31 Percentage of Participants
|
23 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Irritability (>3 hours duration)
|
5 Percentage of Participants
|
3 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Arthralgia
|
8 Percentage of Participants
|
7 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Arthralgia (Unwllling to move due to pain)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Any Diarrhea
|
15 Percentage of Participants
|
7 Percentage of Participants
|
—
|
|
Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Grade 3 Diarrhea (≥ 5 episodes per 24 hours)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
—
|
Adverse Events
Menactra® Group 1
Serious events: 4 serious events
Other events: 58 other events
Deaths: 0 deaths
Menactra® Group 2
Serious events: 3 serious events
Other events: 57 other events
Deaths: 0 deaths
Menactra® Group 3
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menactra® Group 1
n=111 participants at risk
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=111 participants at risk
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=111 participants at risk
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Infections and infestations
Urinary tract infection
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Metabolism and nutrition disorders
Dehydration
|
1.8%
2/111 • Number of events 2 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Psychiatric disorders
Breath holding
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
Other adverse events
| Measure |
Menactra® Group 1
n=111 participants at risk
Participants aged 2 to less than 4 years who received 2 doses of vaccine
|
Menactra® Group 2
n=111 participants at risk
Participants aged 4 to less than 6 years who received 2 doses of vaccine
|
Menactra® Group 3
n=111 participants at risk
Participants aged 6 to less than 11 years who received a single dose of vaccine
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
17.4%
19/109 • Number of events 19 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
8.3%
9/108 • Number of events 9 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
2.7%
3/111 • Number of events 3 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Gastrointestinal disorders
Vomiting
|
5.5%
6/109 • Number of events 6 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
6.8%
7/103 • Number of events 7 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
1.8%
2/111 • Number of events 2 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Injection site erythma
|
46.8%
51/109 • Number of events 51 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
35.9%
37/103 • Number of events 37 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
31.5%
35/111 • Number of events 35 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Fever
|
7.3%
8/109 • Number of events 8 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
12.6%
13/103 • Number of events 13 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Irritability
|
34.9%
38/109 • Number of events 38 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
23.3%
24/103 • Number of events 24 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
10.8%
12/111 • Number of events 12 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Injection site pain
|
53.2%
58/109 • Number of events 58 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
52.8%
57/108 • Number of events 57 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
57.7%
64/111 • Number of events 64 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Pyrexia
|
12.6%
14/111 • Number of events 14 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
7.2%
8/111 • Number of events 8 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
2.7%
3/111 • Number of events 3 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Injection site swelling
|
22.9%
25/109 • Number of events 25 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
17.6%
19/108 • Number of events 19 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
22.5%
25/111 • Number of events 25 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
8/109 • Number of events 8 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
8.3%
9/108 • Number of events 9 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
7.2%
8/111 • Number of events 8 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Nervous system disorders
Drowsiness
|
21.1%
23/109 • Number of events 23 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
17.5%
18/103 • Number of events 18 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
14.4%
16/111 • Number of events 16 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Nervous system disorders
Headache
|
7.3%
8/109 • Number of events 8 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
14.8%
16/108 • Number of events 16 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
22.5%
25/111 • Number of events 25 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Psychiatric disorders
Anorexia
|
20.2%
22/109 • Number of events 22 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
16.5%
17/103 • Number of events 17 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
7.2%
8/111 • Number of events 8 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.2%
18/111 • Number of events 25 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
13.5%
15/111 • Number of events 16 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
9.0%
10/111 • Number of events 12 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
3.6%
4/111 • Number of events 4 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
General disorders
Injection site induration
|
6.3%
7/111 • Number of events 7 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
4.5%
5/111 • Number of events 5 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
1.8%
2/111 • Number of events 2 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
6/111 • Number of events 7 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
3.6%
4/111 • Number of events 4 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
1.8%
2/111 • Number of events 2 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Infections and infestations
Otitis media
|
5.4%
6/111 • Number of events 6 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.90%
1/111 • Number of events 1 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
6/111 • Number of events 6 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
3.6%
4/111 • Number of events 4 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
0.00%
0/111 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.5%
5/111 • Number of events 5 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
8.1%
9/111 • Number of events 9 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
|
1.8%
2/111 • Number of events 2 • Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 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