Trial Outcomes & Findings for A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers (NCT NCT00384397)
NCT ID: NCT00384397
Last Updated: 2016-04-14
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1128 participants
Primary outcome timeframe
30 days post-visit 2 Menactra®
Results posted on
2016-04-14
Participant Flow
Participants were enrolled from 20 September 2006 to 29 September 2007 at 71 US clinical centers.
A total of 1118 participants were enrolled, vaccinated, and included in data analysis.
Participant milestones
| Measure |
Group 1: Menactra® Vaccine
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Overall Study
STARTED
|
407
|
293
|
418
|
|
Overall Study
COMPLETED
|
375
|
247
|
385
|
|
Overall Study
NOT COMPLETED
|
32
|
46
|
33
|
Reasons for withdrawal
| Measure |
Group 1: Menactra® Vaccine
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
|
Overall Study
Protocol Violation
|
7
|
15
|
13
|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
3
|
|
Overall Study
Withdrawal by Subject
|
14
|
17
|
15
|
Baseline Characteristics
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Baseline characteristics by cohort
| Measure |
Group 1: Menactra® Vaccine
n=407 Participants
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=293 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=418 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
Total
n=1118 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
407 Participants
n=5 Participants
|
293 Participants
n=7 Participants
|
418 Participants
n=5 Participants
|
1118 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
|
278.7 Days
STANDARD_DEVIATION 10.55 • n=5 Participants
|
279.8 Days
STANDARD_DEVIATION 10.93 • n=7 Participants
|
279.5 Days
STANDARD_DEVIATION 11.11 • n=5 Participants
|
279.3 Days
STANDARD_DEVIATION 10.86 • n=4 Participants
|
|
Sex: Female, Male
Female
|
217 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
217 Participants
n=5 Participants
|
562 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
556 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
407 participants
n=5 Participants
|
293 participants
n=7 Participants
|
418 participants
n=5 Participants
|
1118 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 30 days post-visit 2 Menactra®Population: Antibody titers were assessed in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® Vaccine
n=277 Participants
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=180 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=267 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup A
|
96 Percentage of Participants
|
93 Percentage of Participants
|
91 Percentage of Participants
|
|
Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup C
|
100 Percentage of Participants
|
99 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup Y
|
96 Percentage of Participants
|
97 Percentage of Participants
|
95 Percentage of Participants
|
|
Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup W-135
|
86 Percentage of Participants
|
88 Percentage of Participants
|
81 Percentage of Participants
|
SECONDARY outcome
Timeframe: 0-7 days post-vaccinationPopulation: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population.
Injection site reactions: tenderness, erythema, and swelling at the Menactra site (Visits 1 and 2) and the measles-mumps-rubella, varicella (MMRV) and pneumococcal conjugate vaccine (PCV) sites (only Visit 2); Systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability following each vaccination.
Outcome measures
| Measure |
Group 1: Menactra® Vaccine
n=407 Participants
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=293 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=418 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Erythema
|
22 Percentage of Participants
|
25 Percentage of Participants
|
22 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Erythema (≥ 2.0 in)
|
1 Percentage of Participants
|
1 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Swelling
|
11 Percentage of Participants
|
15 Percentage of Participants
|
11 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Tenderness - Menactra Site
|
36 Percentage of Participants
|
39 Percentage of Participants
|
48 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Tenderness (Cries when limb is moved)
|
1 Percentage of Participants
|
1 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Swelling - Menactra Site
|
10 Percentage of Participants
|
14 Percentage of Participants
|
17 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Swelling (≥ 2.0 in) - Menactra Site
|
1 Percentage of Participants
|
3 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Swelling - MMRV Site
|
0 Percentage of Participants
|
12 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Swelling (≥ 2.0 in)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Solicited Systemic Reaction Post-Dose 1
|
68 Percentage of Participants
|
64 Percentage of Participants
|
67 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Fever (Any Route)
|
16 Percentage of Participants
|
26 Percentage of Participants
|
22 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC)
|
1 Percentage of Participants
|
4 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Drowsiness (Sleeps most of time)
|
1 Percentage of Participants
|
1 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Solicited Injection Site Reaction Post-Dose 1
|
41 Percentage of Participants
|
48 Percentage of Participants
|
43 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Tenderness
|
32 Percentage of Participants
|
35 Percentage of Participants
|
32 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Solicited Injection Site Reaction Post-Dose 2
|
43 Percentage of Participants
|
49 Percentage of Participants
|
54 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Erythema - Menactra Site
|
23 Percentage of Participants
|
26 Percentage of Participants
|
27 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Erythema (≥ 2.0 in) - Menactra Site
|
1 Percentage of Participants
|
2 Percentage of Participants
|
3 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Tenderness - MMRV Site
|
0 Percentage of Participants
|
37 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Gr 3 Tenderness (Cries when limb moved) MMRV Site
|
0 Percentage of Participants
|
1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Erythema - MMRV Site
|
0 Percentage of Participants
|
23 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Erythema (≥ 2.0 in) - MMRV Site
|
0 Percentage of Participants
|
3 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Swelling (≥ 2.0 in) - MMRV Site
|
0 Percentage of Participants
|
2 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Tenderness - PCV Site
|
0 Percentage of Participants
|
0 Percentage of Participants
|
47 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Gr 3 Tenderness (Cries when limb moved) PCV Site
|
0 Percentage of Participants
|
0 Percentage of Participants
|
1 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Erythema - PCV Site
|
0 Percentage of Participants
|
0 Percentage of Participants
|
30 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Erythema (≥ 2.0 in) - PCV Site
|
0 Percentage of Participants
|
0 Percentage of Participants
|
4 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Swelling - PCV Site
|
0 Percentage of Participants
|
0 Percentage of Participants
|
20 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Vomiting
|
7 Percentage of Participants
|
10 Percentage of Participants
|
11 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Vomiting (≥ 6 episodes per 24 hr)
|
1 Percentage of Participants
|
1 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Crying Abnormal
|
35 Percentage of Participants
|
39 Percentage of Participants
|
38 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Crying Abnormal (> 3 hours)
|
2 Percentage of Participants
|
1 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Drowsiness
|
28 Percentage of Participants
|
32 Percentage of Participants
|
33 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Appetite Lost
|
26 Percentage of Participants
|
32 Percentage of Participants
|
32 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)
|
2 Percentage of Participants
|
2 Percentage of Participants
|
2 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Irritability
|
52 Percentage of Participants
|
61 Percentage of Participants
|
57 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Grade 3 Irritability (Inconsolable)
|
3 Percentage of Participants
|
3 Percentage of Participants
|
5 Percentage of Participants
|
|
Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Any Solicited Systemic Reaction Post-Dose 2
|
64 Percentage of Participants
|
74 Percentage of Participants
|
68 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-Visit 2 Menactra®Population: Antibody titers were assessed in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® Vaccine
n=277 Participants
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=180 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=267 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup Y
|
99 Percentage of Participants
|
99 Percentage of Participants
|
98 Percentage of Participants
|
|
Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup W-135
|
93 Percentage of Participants
|
96 Percentage of Participants
|
91 Percentage of Participants
|
|
Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup A
|
98 Percentage of Participants
|
98 Percentage of Participants
|
97 Percentage of Participants
|
|
Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Meningococcal Serogroup C
|
100 Percentage of Participants
|
100 Percentage of Participants
|
99 Percentage of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 days post-Visit 2 Menactra®Population: Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population.
Outcome measures
| Measure |
Group 1: Menactra® Vaccine
n=277 Participants
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=180 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=267 Participants
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.
Meningococcal Serogroup A
|
54.9 Titers
Interval 46.8 to 64.5
|
52 Titers
Interval 41.8 to 64.7
|
41 Titers
Interval 34.6 to 48.5
|
|
Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.
Meningococcal Serogroup C
|
141.8 Titers
Interval 123.5 to 162.9
|
161.9 Titers
Interval 136.3 to 192.3
|
109.5 Titers
Interval 94.1 to 127.5
|
|
Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.
Meningococcal Serogroup Y
|
52.4 Titers
Interval 45.4 to 60.6
|
60.2 Titers
Interval 50.4 to 71.7
|
39.9 Titers
Interval 34.4 to 46.2
|
|
Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.
Meningococcal Serogroup W-135
|
24.3 Titers
Interval 20.8 to 28.3
|
27.9 Titers
Interval 22.7 to 34.3
|
17.9 Titers
Interval 15.2 to 21.0
|
Adverse Events
Group 1: Menactra® Vaccine
Serious events: 16 serious events
Other events: 210 other events
Deaths: 0 deaths
Group 2: Menactra® + MMRV
Serious events: 9 serious events
Other events: 137 other events
Deaths: 0 deaths
Group 3: Menactra® + PCV
Serious events: 17 serious events
Other events: 222 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Menactra® Vaccine
n=407 participants at risk
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=293 participants at risk
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=418 participants at risk
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Autoimmune neutropenia
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Gastrointestinal disorders
Barrett's esophagus
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.34%
1/293 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Gastrointestinal disorders
Intussusception
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
General disorders
Pyrexia
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Bronchiolitis
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
1.0%
3/293 • Number of events 3 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Cellulitis
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.34%
1/293 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Condyloma acuminatum
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.34%
1/293 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Febrile infection
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.34%
1/293 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.72%
3/418 • Number of events 3 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.34%
1/293 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Pneumonia
|
0.49%
2/407 • Number of events 2 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Pneumonia viral
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Pyelonephritis
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Staphylococcal abscess
|
0.49%
2/407 • Number of events 2 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.34%
1/293 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Metabolism and nutrition disorders
Diabetes mellitus insulin-dependent
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Nervous system disorders
Convulsion
|
0.25%
1/407 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/418 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Nervous system disorders
Febrile convulsion
|
0.49%
2/407 • Number of events 5 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.72%
3/418 • Number of events 3 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/407 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.00%
0/293 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
0.24%
1/418 • Number of events 1 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
Other adverse events
| Measure |
Group 1: Menactra® Vaccine
n=407 participants at risk
Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
|
Group 2: Menactra® + MMRV
n=293 participants at risk
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
|
Group 3: Menactra® + PCV
n=418 participants at risk
Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
9.3%
38/407 • Number of events 41 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
9.9%
29/293 • Number of events 38 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
9.6%
40/418 • Number of events 48 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Gastrointestinal disorders
Teething
|
13.8%
56/407 • Number of events 75 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
11.6%
34/293 • Number of events 54 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
10.3%
43/418 • Number of events 64 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
General disorders
Pyrexia
|
7.9%
32/407 • Number of events 36 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
7.2%
21/293 • Number of events 24 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
8.9%
37/418 • Number of events 40 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
29/407 • Number of events 32 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
5.1%
15/293 • Number of events 17 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
4.3%
18/418 • Number of events 21 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Otitis media
|
17.0%
69/407 • Number of events 81 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
16.4%
48/293 • Number of events 55 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
20.3%
85/418 • Number of events 96 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.5%
47/407 • Number of events 53 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
11.3%
33/293 • Number of events 37 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
19.4%
81/418 • Number of events 90 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
37/407 • Number of events 37 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
6.8%
20/293 • Number of events 22 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
5.3%
22/418 • Number of events 27 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.2%
21/407 • Number of events 22 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
1.4%
4/293 • Number of events 4 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
3.1%
13/418 • Number of events 13 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.1%
33/407 • Number of events 40 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
6.5%
19/293 • Number of events 20 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
6.9%
29/418 • Number of events 33 • Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months.
|
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