Trial Outcomes & Findings for Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age (NCT NCT00643916)
NCT ID: NCT00643916
Last Updated: 2014-02-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
378 participants
Primary outcome timeframe
Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
Results posted on
2014-02-14
Participant Flow
Participants were enrolled from 10 December 2004 to 14 May 2005 in 15 medical centers in the US
A total of 378 participants that met the inclusion and exclusion criteria were enrolled, 369 were vaccinated.
Participant milestones
| Measure |
Vaccinated at Age 9 and 12 Months
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
67
|
68
|
62
|
59
|
67
|
|
Overall Study
COMPLETED
|
51
|
61
|
62
|
60
|
57
|
66
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
6
|
2
|
2
|
1
|
Reasons for withdrawal
| Measure |
Vaccinated at Age 9 and 12 Months
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
|---|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
2
|
1
|
0
|
1
|
|
Overall Study
Not Vaccinated
|
2
|
2
|
3
|
0
|
2
|
0
|
Baseline Characteristics
Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age
Baseline characteristics by cohort
| Measure |
Vaccinated at Age 9 and 12 Months
n=55 Participants
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
n=67 Participants
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
n=68 Participants
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
n=62 Participants
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
n=59 Participants
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
n=67 Participants
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
55 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
62 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
67 Participants
n=8 Participants
|
378 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
8.9 Months
STANDARD_DEVIATION 0.4 • n=5 Participants
|
8.9 Months
STANDARD_DEVIATION 0.3 • n=7 Participants
|
11.9 Months
STANDARD_DEVIATION 0.3 • n=5 Participants
|
14.9 Months
STANDARD_DEVIATION 0.3 • n=4 Participants
|
17.9 Months
STANDARD_DEVIATION 0.3 • n=21 Participants
|
48.0 Months
STANDARD_DEVIATION 10.3 • n=8 Participants
|
18.7 Months
STANDARD_DEVIATION 14.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
179 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
37 Participants
n=8 Participants
|
199 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
67 participants
n=7 Participants
|
68 participants
n=5 Participants
|
62 participants
n=4 Participants
|
59 participants
n=21 Participants
|
67 participants
n=8 Participants
|
378 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2Population: Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Outcome measures
| Measure |
Vaccinated at Age 9 and 12 Months
n=40 Participants
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
n=50 Participants
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
n=54 Participants
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
n=55 Participants
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
n=51 Participants
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
n=63 Participants
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
|---|---|---|---|---|---|---|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup Y (Post dose 2)
|
95 Percentage of Participants
|
94 Percentage of Participants
|
96 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup A (Baseline)
|
38 Percentage of Participants
|
44 Percentage of Participants
|
33 Percentage of Participants
|
40 Percentage of Participants
|
40 Percentage of Participants
|
71 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup A (Post dose 1)
|
76 Percentage of Participants
|
67 Percentage of Participants
|
52 Percentage of Participants
|
76 Percentage of Participants
|
65 Percentage of Participants
|
87 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup A (Post dose 2)
|
89 Percentage of Participants
|
89 Percentage of Participants
|
85 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup C (Baseline)
|
5 Percentage of Participants
|
2 Percentage of Participants
|
0 Percentage of Participants
|
2 Percentage of Participants
|
4 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup C (Post dose 1)
|
83 Percentage of Participants
|
85 Percentage of Participants
|
85 Percentage of Participants
|
86 Percentage of Participants
|
77 Percentage of Participants
|
49 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup C (Post dose 2)
|
100 Percentage of Participants
|
100 Percentage of Participants
|
100 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup Y (Baseline)
|
3 Percentage of Participants
|
0 Percentage of Participants
|
2 Percentage of Participants
|
2 Percentage of Participants
|
8 Percentage of Participants
|
8 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup Y (Post dose 1)
|
21 Percentage of Participants
|
24 Percentage of Participants
|
35 Percentage of Participants
|
33 Percentage of Participants
|
47 Percentage of Participants
|
66 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup W-135 (Baseline)
|
3 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
2 Percentage of Participants
|
0 Percentage of Participants
|
10 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup W-135 (Post dose 1)
|
24 Percentage of Participants
|
27 Percentage of Participants
|
18 Percentage of Participants
|
42 Percentage of Participants
|
36 Percentage of Participants
|
61 Percentage of Participants
|
|
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Meningococcal serogroup W-135 (Post dose 2)
|
92 Percentage of Participants
|
92 Percentage of Participants
|
96 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 0 up to 7 post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.
Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Outcome measures
| Measure |
Vaccinated at Age 9 and 12 Months
n=53 Participants
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
n=65 Participants
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
n=65 Participants
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
n=62 Participants
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
n=57 Participants
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
n=67 Participants
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
|---|---|---|---|---|---|---|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Irritability (inconsolable)
|
10 Percentage of participants
|
7 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Solicited Injection Site Reaction-Any Dose
|
74 Percentage of participants
|
69 Percentage of participants
|
65 Percentage of participants
|
53 Percentage of participants
|
61 Percentage of participants
|
55 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Solicited Injection Site Reaction - Dose 1
|
62 Percentage of participants
|
45 Percentage of participants
|
57 Percentage of participants
|
53 Percentage of participants
|
61 Percentage of participants
|
55 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Solicited Injection Site Reaction - Dose 1
|
0 Percentage of participants
|
2 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
2 Percentage of participants
|
8 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Erythema
|
29 Percentage of participants
|
36 Percentage of participants
|
23 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Erythema (≥ 2 inches)
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Swelling
|
25 Percentage of participants
|
20 Percentage of participants
|
11 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Swelling (≥ 2 inches)
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Tenderness
|
52 Percentage of participants
|
42 Percentage of participants
|
37 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Tenderness (cries when inj. limb is moved)
|
2 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Solicited Systemic Reaction-Any Dose
|
89 Percentage of participants
|
84 Percentage of participants
|
72 Percentage of participants
|
75 Percentage of participants
|
72 Percentage of participants
|
31 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Solicited Systemic Reaction Dose 1
|
72 Percentage of participants
|
75 Percentage of participants
|
60 Percentage of participants
|
75 Percentage of participants
|
72 Percentage of participants
|
31 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Solicited Systemic Reaction Dose 1
|
9 Percentage of participants
|
8 Percentage of participants
|
5 Percentage of participants
|
12 Percentage of participants
|
7 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Fever
|
28 Percentage of participants
|
15 Percentage of participants
|
10 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Fever (≥ 39.6 ºC)
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Vomiting
|
19 Percentage of participants
|
10 Percentage of participants
|
8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Vomiting (≥ 6 episodes per day)
|
4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Crying Abnormal
|
50 Percentage of participants
|
29 Percentage of participants
|
27 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Crying Abnormal (> 3 hours)
|
6 Percentage of participants
|
2 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Drowsiness
|
42 Percentage of participants
|
25 Percentage of participants
|
18 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Drowsiness (difficulty to wake up)
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Appetite Lost
|
31 Percentage of participants
|
32 Percentage of participants
|
29 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Appetite Lost (refuses ≥ 3 feeds)
|
0 Percentage of participants
|
3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Irritability
|
63 Percentage of participants
|
42 Percentage of participants
|
44 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Irrtability (inconsolable)
|
4 Percentage of participants
|
5 Percentage of participants
|
3 Percentage of participants
|
3 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Solicited Injection Site Reaction - Dose 2
|
63 Percentage of participants
|
54 Percentage of participants
|
48 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Solicited Injection Site Reaction - Dose 2
|
2 Percentage of participants
|
7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Any Solicited Systemic Reaction Dose 2
|
83 Percentage of participants
|
56 Percentage of participants
|
53 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Solicited Systemic Reaction Dose 2
|
13 Percentage of participants
|
9 Percentage of participants
|
5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Grade 3 Vomiting ≥ 6 episodes per day)
|
0 Percentage of participants
|
2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
Adverse Events
Vaccinated at Age 9 and 12 Months
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Vaccinated at Age 9 and 15 Months
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Vaccinated at Age 12 and 15 Months
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
Vaccinated at Age 15 Months
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Vaccinated at Age 18 Months
Serious events: 5 serious events
Other events: 33 other events
Deaths: 0 deaths
Vaccinated at Age 3 Years to <6 Years
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccinated at Age 9 and 12 Months
n=53 participants at risk
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
n=65 participants at risk
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
n=65 participants at risk
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
n=61 participants at risk
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
n=57 participants at risk
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
n=67 participants at risk
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
1.8%
1/57 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Abscess
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
1.8%
1/57 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
1.8%
1/57 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
1.8%
1/57 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/65 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
1.8%
1/57 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
Other adverse events
| Measure |
Vaccinated at Age 9 and 12 Months
n=53 participants at risk
Participants received Menactra vaccine at 9 and 12 months of age
|
Vaccinated at Age 9 and 15 Months
n=65 participants at risk
Participants received Menactra vaccine at 9 months and 15 months of age
|
Vaccinated at Age 12 and 15 Months
n=65 participants at risk
Participants received Menactra vaccine at 12 months and 15 months of age
|
Vaccinated at Age 15 Months
n=61 participants at risk
Participants received Menactra vaccine at 15 months of age
|
Vaccinated at Age 18 Months
n=57 participants at risk
Participants received Menactra vaccine at 18 months of age
|
Vaccinated at Age 3 Years to <6 Years
n=67 participants at risk
Participants received Menomune vaccine at age 3 years to \<6 years of age
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
5.7%
3/53 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
6.2%
4/65 • Number of events 5 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
3.3%
2/61 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
5.3%
3/57 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
General disorders
Injection site haemorrhage
|
5.7%
3/53 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
13.8%
9/65 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
10.8%
7/65 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
7.0%
4/57 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
10.4%
7/67 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
|
General disorders
Pyrexia
|
11.3%
6/53 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
20.0%
13/65 • Number of events 16 • Adverse events data were collected for 6 months post-vaccination.
|
10.8%
7/65 • Number of events 8 • Adverse events data were collected for 6 months post-vaccination.
|
4.9%
3/61 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
12.3%
7/57 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
6.0%
4/67 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Otitis media
|
5.7%
3/53 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
20.0%
13/65 • Number of events 15 • Adverse events data were collected for 6 months post-vaccination.
|
9.2%
6/65 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
8.2%
5/61 • Number of events 5 • Adverse events data were collected for 6 months post-vaccination.
|
7.0%
4/57 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
|
Eye disorders
Conjunctivitis
|
1.9%
1/53 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
3.1%
2/65 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
4.9%
3/61 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
5.3%
3/57 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.0%
9/53 • Number of events 12 • Adverse events data were collected for 6 months post-vaccination.
|
20.0%
13/65 • Number of events 18 • Adverse events data were collected for 6 months post-vaccination.
|
12.3%
8/65 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
9.8%
6/61 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
14.0%
8/57 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
3.0%
2/67 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
|
Gastrointestinal disorders
Teething
|
15.1%
8/53 • Number of events 10 • Adverse events data were collected for 6 months post-vaccination.
|
20.0%
13/65 • Number of events 22 • Adverse events data were collected for 6 months post-vaccination.
|
26.2%
17/65 • Number of events 23 • Adverse events data were collected for 6 months post-vaccination.
|
8.2%
5/61 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
8.8%
5/57 • Number of events 5 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Otitis media acute
|
5.7%
3/53 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
3.5%
2/57 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Rhinitis
|
3.8%
2/53 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
3.1%
2/65 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
6.6%
4/61 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
3.5%
2/57 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
1.5%
1/67 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Sinusitis
|
3.8%
2/53 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
6.2%
4/65 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.3%
6/53 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
20.0%
13/65 • Number of events 13 • Adverse events data were collected for 6 months post-vaccination.
|
12.3%
8/65 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
9.8%
6/61 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
8.8%
5/57 • Number of events 5 • Adverse events data were collected for 6 months post-vaccination.
|
3.0%
2/67 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.5%
13/53 • Number of events 15 • Adverse events data were collected for 6 months post-vaccination.
|
18.5%
12/65 • Number of events 14 • Adverse events data were collected for 6 months post-vaccination.
|
18.5%
12/65 • Number of events 16 • Adverse events data were collected for 6 months post-vaccination.
|
11.5%
7/61 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
12.3%
7/57 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
13.4%
9/67 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.3%
6/53 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
10.8%
7/65 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
7.7%
5/65 • Number of events 8 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
8.8%
5/57 • Number of events 5 • Adverse events data were collected for 6 months post-vaccination.
|
7.5%
5/67 • Number of events 5 • Adverse events data were collected for 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
13.2%
7/53 • Number of events 9 • Adverse events data were collected for 6 months post-vaccination.
|
9.2%
6/65 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
15.4%
10/65 • Number of events 12 • Adverse events data were collected for 6 months post-vaccination.
|
11.5%
7/61 • Number of events 7 • Adverse events data were collected for 6 months post-vaccination.
|
3.5%
2/57 • Number of events 2 • Adverse events data were collected for 6 months post-vaccination.
|
6.0%
4/67 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/53 • Adverse events data were collected for 6 months post-vaccination.
|
6.2%
4/65 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/65 • Adverse events data were collected for 6 months post-vaccination.
|
1.6%
1/61 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
1.9%
1/53 • Number of events 1 • Adverse events data were collected for 6 months post-vaccination.
|
9.2%
6/65 • Number of events 6 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
4.9%
3/61 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/57 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 6 months post-vaccination.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.5%
4/53 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
4.6%
3/65 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
6.2%
4/65 • Number of events 4 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/61 • Adverse events data were collected for 6 months post-vaccination.
|
5.3%
3/57 • Number of events 3 • Adverse events data were collected for 6 months post-vaccination.
|
0.00%
0/67 • Adverse events data were collected for 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