A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
Study Details
Study Description
Brief Summary
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone, and concomitantly with other routine pediatric vaccines typically administered between 12 and 15 months of age.
Primary Objective:
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135.
Secondary Objectives:
Immunogenicity
-
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with Hib and MMRV vaccines.
-
To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, when Menactra vaccine is administered alone or concomitantly with PCV vaccine.
Safety
- To describe the safety profile within 7 and 30 days of each vaccination, and serious adverse events (SAEs) throughout the course of the study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1: Menactra® Vaccine Participants will receive Menactra® vaccine at age 9 months and 12 months, respectively. |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
0.5 mL, Intramuscular
Other Names:
|
| Experimental: Group 2: Menactra® + MMRV Participants will receive Menactra® at age 9 months followed by Menactra® and Measles-Mumps-Rubella-Varicella (MMRV) vaccines at Age 12 Months |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
|
| Experimental: Group 3: Menactra® + PCV Participants will receive Menactra® at age 9 months followed by Menactra® and Pneumococcal Conjugate (PCV) vaccines at Age 12 Months |
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) [30 days post-visit 2 Menactra®]
Secondary Outcome Measures
- Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination [0-7 days post-vaccination]
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.
Other Outcome Measures
- Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) [30 days post-Visit 2 Menactra®]
- Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. [30 days post-Visit 2 Menactra®]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy, as determined by medical history and physical examination.
-
Aged 9 months (249 to 291 days) at the time of enrollment.
-
The parent or legal guardian has signed and dated the Institutional Review Board-approved informed consent form
Exclusion Criteria:
-
Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, or autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
-
Known or suspected impairment of immunologic function.
-
Acute medical illness within the last 72 hours, or temperature ≥ 100.4 ºF (≥ 38.0 ºC) at the time of enrollment.
-
History of documented invasive meningococcal disease or previous meningococcal vaccination.
-
Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian
-
Received either immune globulin or other blood products within the last 3 months, or received injected or oral corticosteroids, or other immunomodulator therapy within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting < 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.
-
Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops are not included in this exclusion criterion.
-
Suspected or known hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.
-
Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.
-
Parent or legal guardian unable or unwilling to comply with the study procedures.
-
Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.
-
Diagnosed with any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
-
Received any vaccine in the 30-day period prior to receipt of study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of any study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their 4th dose of Pneumococcal Conjugate (PCV) or Hib vaccine or their first dose of Measles-Mumps-Rubella-Varicella (MMRV) vaccine before enrollment.
-
Personal or family history of Guillain-Barré Syndrome (GBS).
-
History of seizures, including febrile seizures, or any other neurologic disorder.
-
Known hypersensitivity to dry natural rubber latex (pertinent to the Menactra® vaccine needle shield)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montgomery | Alabama | United States | 36106 | |
| 2 | Fayetteville | Arkansas | United States | 72703 | |
| 3 | Jonesboro | Arkansas | United States | 72401 | |
| 4 | Little Rock | Arkansas | United States | 72202-3591 | |
| 5 | Little Rock | Arkansas | United States | 72205 | |
| 6 | Norwich | Connecticut | United States | 06360 | |
| 7 | Cocoa Beach | Florida | United States | 32931 | |
| 8 | Viera | Florida | United States | 32955 | |
| 9 | Atlanta | Georgia | United States | 30322 | |
| 10 | Marietta | Georgia | United States | 30062 | |
| 11 | Bardstown | Kentucky | United States | 40004 | |
| 12 | Woburn | Massachusetts | United States | 01801 | |
| 13 | Bridgeton | Missouri | United States | 63044 | |
| 14 | St. Louis | Missouri | United States | 63141 | |
| 15 | Las Vegas | Nevada | United States | 89104 | |
| 16 | Rochester | New York | United States | 14620 | |
| 17 | Syracuse | New York | United States | 13210 | |
| 18 | Chapel Hill | North Carolina | United States | 27514 | |
| 19 | Goldsboro | North Carolina | United States | 27534 | |
| 20 | Laurinburg | North Carolina | United States | 28352 | |
| 21 | Sylva | North Carolina | United States | 28779 | |
| 22 | Cincinnati | Ohio | United States | 45229-3039 | |
| 23 | Cleveland | Ohio | United States | 44106 | |
| 24 | Columbus | Ohio | United States | 43205 | |
| 25 | Tulsa | Oklahoma | United States | 74127 | |
| 26 | Pittsburgh | Pennsylvania | United States | 15241 | |
| 27 | Sellersville | Pennsylvania | United States | 18960 | |
| 28 | Kingsport | Tennessee | United States | 37660 | |
| 29 | Ft. Worth | Texas | United States | 76107 | |
| 30 | Layton | Utah | United States | 84041 | |
| 31 | Ogden | Utah | United States | 84405 | |
| 32 | Pleasant Grove | Utah | United States | 84062 | |
| 33 | Provo | Utah | United States | 84604 | |
| 34 | Salt Lake City | Utah | United States | 84123 | |
| 35 | Charlottesville | Virginia | United States | 22911 | |
| 36 | Midlothian | Virginia | United States | 23113 | |
| 37 | Norfolk | Virginia | United States | 23510 | |
| 38 | Spokane | Washington | United States | 99220 | |
| 39 | La Crosse | Wisconsin | United States | 54601 |
Sponsors and Collaborators
- Sanofi Pasteur, a Sanofi Company
Investigators
- Study Director: Medical Monitor, Sanofi Pasteur Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MTA44
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled from 20 September 2006 to 29 September 2007 at 71 US clinical centers. |
|---|---|
| Pre-assignment Detail | A total of 1118 participants were enrolled, vaccinated, and included in data analysis. |
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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. |
| Period Title: Overall Study | |||
| STARTED | 407 | 293 | 418 |
| COMPLETED | 375 | 247 | 385 |
| NOT COMPLETED | 32 | 46 | 33 |
Baseline Characteristics
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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 of all reporting groups |
| Overall Participants | 407 | 293 | 418 | 1118 |
| Age (Count of Participants) | ||||
| <=18 years |
407
100%
|
293
100%
|
418
100%
|
1118
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (Days) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Days] |
278.7
(10.55)
|
279.8
(10.93)
|
279.5
(11.11)
|
279.3
(10.86)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
217
53.3%
|
128
43.7%
|
217
51.9%
|
562
50.3%
|
| Male |
190
46.7%
|
165
56.3%
|
201
48.1%
|
556
49.7%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
407
100%
|
293
100%
|
418
100%
|
1118
100%
|
Outcome Measures
| Title | Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) |
|---|---|
| Description | |
| Time Frame | 30 days post-visit 2 Menactra® |
Outcome Measure Data
| Analysis Population Description |
|---|
| Antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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. |
| Measure Participants | 277 | 180 | 267 |
| Meningococcal Serogroup A |
96
23.6%
|
93
31.7%
|
91
21.8%
|
| Meningococcal Serogroup C |
100
24.6%
|
99
33.8%
|
98
23.4%
|
| Meningococcal Serogroup Y |
96
23.6%
|
97
33.1%
|
95
22.7%
|
| Meningococcal Serogroup W-135 |
86
21.1%
|
88
30%
|
81
19.4%
|
| Title | Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC) |
|---|---|
| Description | |
| Time Frame | 30 days post-Visit 2 Menactra® |
Outcome Measure Data
| Analysis Population Description |
|---|
| Antibody titers were assessed in the per-protocol population. |
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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. |
| Measure Participants | 277 | 180 | 267 |
| Meningococcal Serogroup A |
98
24.1%
|
98
33.4%
|
97
23.2%
|
| Meningococcal Serogroup C |
100
24.6%
|
100
34.1%
|
99
23.7%
|
| Meningococcal Serogroup Y |
99
24.3%
|
99
33.8%
|
98
23.4%
|
| Meningococcal Serogroup W-135 |
93
22.9%
|
96
32.8%
|
91
21.8%
|
| Title | Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months. |
|---|---|
| Description | |
| Time Frame | 30 days post-Visit 2 Menactra® |
Outcome Measure Data
| Analysis Population Description |
|---|
| Geometric mean titers and their 95% Confidence Intervals, measured by SBA-HC, were assessed in the per-protocol population. |
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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. |
| Measure Participants | 277 | 180 | 267 |
| Meningococcal Serogroup A |
54.9
|
52
|
41
|
| Meningococcal Serogroup C |
141.8
|
161.9
|
109.5
|
| Meningococcal Serogroup Y |
52.4
|
60.2
|
39.9
|
| Meningococcal Serogroup W-135 |
24.3
|
27.9
|
17.9
|
| Title | Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination |
|---|---|
| Description | 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. |
| Time Frame | 0-7 days post-vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. |
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV |
|---|---|---|---|
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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. |
| Measure Participants | 407 | 293 | 418 |
| Any Solicited Injection Site Reaction Post-Dose 1 |
41
10.1%
|
48
16.4%
|
43
10.3%
|
| Any Tenderness |
32
7.9%
|
35
11.9%
|
32
7.7%
|
| Grade 3 Tenderness (Cries when limb is moved) |
1
0.2%
|
0
0%
|
0
0%
|
| Any Erythema |
22
5.4%
|
25
8.5%
|
22
5.3%
|
| Grade 3 Erythema (≥ 2.0 in) |
1
0.2%
|
1
0.3%
|
2
0.5%
|
| Any Swelling |
11
2.7%
|
15
5.1%
|
11
2.6%
|
| Grade 3 Swelling (≥ 2.0 in) |
0
0%
|
2
0.7%
|
1
0.2%
|
| Any Solicited Injection Site Reaction Post-Dose 2 |
43
10.6%
|
49
16.7%
|
54
12.9%
|
| Any Tenderness - Menactra Site |
36
8.8%
|
39
13.3%
|
48
11.5%
|
| Grade 3 Tenderness (Cries when limb is moved) |
0
0%
|
1
0.3%
|
1
0.2%
|
| Any Erythema - Menactra Site |
23
5.7%
|
26
8.9%
|
27
6.5%
|
| Grade 3 Erythema (≥ 2.0 in) - Menactra Site |
1
0.2%
|
2
0.7%
|
3
0.7%
|
| Any Swelling - Menactra Site |
10
2.5%
|
14
4.8%
|
17
4.1%
|
| Grade 3 Swelling (≥ 2.0 in) - Menactra Site |
1
0.2%
|
3
1%
|
2
0.5%
|
| Any Tenderness - MMRV Site |
0
0%
|
37
12.6%
|
0
0%
|
| Gr 3 Tenderness (Cries when limb moved) MMRV Site |
0
0%
|
1
0.3%
|
0
0%
|
| Any Erythema - MMRV Site |
0
0%
|
23
7.8%
|
0
0%
|
| Grade 3 Erythema (≥ 2.0 in) - MMRV Site |
0
0%
|
3
1%
|
0
0%
|
| Any Swelling - MMRV Site |
0
0%
|
12
4.1%
|
0
0%
|
| Grade 3 Swelling (≥ 2.0 in) - MMRV Site |
0
0%
|
2
0.7%
|
0
0%
|
| Any Tenderness - PCV Site |
0
0%
|
0
0%
|
47
11.2%
|
| Gr 3 Tenderness (Cries when limb moved) PCV Site |
0
0%
|
0
0%
|
1
0.2%
|
| Any Erythema - PCV Site |
0
0%
|
0
0%
|
30
7.2%
|
| Grade 3 Erythema (≥ 2.0 in) - PCV Site |
0
0%
|
0
0%
|
4
1%
|
| Any Swelling - PCV Site |
0
0%
|
0
0%
|
20
4.8%
|
| Grade 3 Swelling (≥ 2.0 in) |
0
0%
|
0
0%
|
3
0.7%
|
| Any Solicited Systemic Reaction Post-Dose 1 |
68
16.7%
|
64
21.8%
|
67
16%
|
| Any Fever (Any Route) |
13
3.2%
|
12
4.1%
|
13
3.1%
|
| Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) |
1
0.2%
|
2
0.7%
|
2
0.5%
|
| Any Vomiting |
16
3.9%
|
14
4.8%
|
15
3.6%
|
| Grade 3 Vomiting (≥ 6 episodes per 24 hr) |
1
0.2%
|
0
0%
|
0
0%
|
| Any Crying Abnormal |
34
8.4%
|
36
12.3%
|
33
7.9%
|
| Grade 3 Crying Abnormal (> 3 hours) |
2
0.5%
|
2
0.7%
|
1
0.2%
|
| Any Drowsiness |
31
7.6%
|
30
10.2%
|
30
7.2%
|
| Grade 3 Drowsiness (Sleeps most of time) |
1
0.2%
|
1
0.3%
|
0
0%
|
| Any Appetite Lost |
25
6.1%
|
26
8.9%
|
27
6.5%
|
| Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) |
1
0.2%
|
0
0%
|
0
0%
|
| Any Irritability |
55
13.5%
|
57
19.5%
|
53
12.7%
|
| Grade 3 Irritability (Inconsolable) |
2
0.5%
|
2
0.7%
|
2
0.5%
|
| Any Solicited Systemic Reaction Post-Dose 2 |
64
15.7%
|
74
25.3%
|
68
16.3%
|
| Any Fever (Any Route) |
16
3.9%
|
26
8.9%
|
22
5.3%
|
| Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) |
1
0.2%
|
4
1.4%
|
1
0.2%
|
| Any Vomiting |
7
1.7%
|
10
3.4%
|
11
2.6%
|
| Grade 3 Vomiting (≥ 6 episodes per 24 hr) |
1
0.2%
|
1
0.3%
|
0
0%
|
| Any Crying Abnormal |
35
8.6%
|
39
13.3%
|
38
9.1%
|
| Grade 3 Crying Abnormal (> 3 hours) |
2
0.5%
|
1
0.3%
|
5
1.2%
|
| Any Drowsiness |
28
6.9%
|
32
10.9%
|
33
7.9%
|
| Grade 3 Drowsiness (Sleeps most of time) |
1
0.2%
|
1
0.3%
|
1
0.2%
|
| Any Appetite Lost |
26
6.4%
|
32
10.9%
|
32
7.7%
|
| Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) |
2
0.5%
|
2
0.7%
|
2
0.5%
|
| Any Irritability |
52
12.8%
|
61
20.8%
|
57
13.6%
|
| Grade 3 Irritability (Inconsolable) |
3
0.7%
|
3
1%
|
5
1.2%
|
Adverse Events
| Time Frame | Adverse events data for each participants were collected from the day of enrollment to the end of study, 9 months. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV | |||
| Arm/Group Description | Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months. | 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. | 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. | |||
All Cause Mortality |
||||||
| Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 16/407 (3.9%) | 9/293 (3.1%) | 17/418 (4.1%) | |||
| Blood and lymphatic system disorders | ||||||
| Autoimmune neutropenia | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Gastrointestinal disorders | ||||||
| Barrett's esophagus | 0/407 (0%) | 0 | 1/293 (0.3%) | 1 | 0/418 (0%) | 0 |
| Inguinal hernia | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| Intussusception | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| General disorders | ||||||
| Pyrexia | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Infections and infestations | ||||||
| Bronchiolitis | 1/407 (0.2%) | 1 | 3/293 (1%) | 3 | 1/418 (0.2%) | 1 |
| Cellulitis | 1/407 (0.2%) | 1 | 1/293 (0.3%) | 1 | 0/418 (0%) | 0 |
| Condyloma acuminatum | 0/407 (0%) | 0 | 1/293 (0.3%) | 1 | 0/418 (0%) | 0 |
| Escherichia bacteraemia | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Febrile infection | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| Gastroenteritis | 0/407 (0%) | 0 | 1/293 (0.3%) | 1 | 3/418 (0.7%) | 3 |
| Pneumococcal sepsis | 0/407 (0%) | 0 | 1/293 (0.3%) | 1 | 0/418 (0%) | 0 |
| Pneumonia | 2/407 (0.5%) | 2 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| Pneumonia respiratory syncytial viral | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Pneumonia viral | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| Pyelonephritis | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Staphylococcal abscess | 2/407 (0.5%) | 2 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Streptococcal bacteraemia | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| Exposure to toxic agent | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| Skull fractured base | 0/407 (0%) | 0 | 1/293 (0.3%) | 1 | 0/418 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Diabetes mellitus insulin-dependent | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Nervous system disorders | ||||||
| Convulsion | 1/407 (0.2%) | 1 | 0/293 (0%) | 0 | 0/418 (0%) | 0 |
| Febrile convulsion | 2/407 (0.5%) | 5 | 0/293 (0%) | 0 | 3/418 (0.7%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Asthma | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
| Pneumonitis | 0/407 (0%) | 0 | 0/293 (0%) | 0 | 1/418 (0.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Group 1: Menactra® Vaccine | Group 2: Menactra® + MMRV | Group 3: Menactra® + PCV | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 210/407 (51.6%) | 137/293 (46.8%) | 222/418 (53.1%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhoea | 38/407 (9.3%) | 41 | 29/293 (9.9%) | 38 | 40/418 (9.6%) | 48 |
| Teething | 56/407 (13.8%) | 75 | 34/293 (11.6%) | 54 | 43/418 (10.3%) | 64 |
| General disorders | ||||||
| Pyrexia | 32/407 (7.9%) | 36 | 21/293 (7.2%) | 24 | 37/418 (8.9%) | 40 |
| Infections and infestations | ||||||
| Nasopharyngitis | 29/407 (7.1%) | 32 | 15/293 (5.1%) | 17 | 18/418 (4.3%) | 21 |
| Otitis media | 69/407 (17%) | 81 | 48/293 (16.4%) | 55 | 85/418 (20.3%) | 96 |
| Upper respiratory tract infection | 47/407 (11.5%) | 53 | 33/293 (11.3%) | 37 | 81/418 (19.4%) | 90 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 37/407 (9.1%) | 37 | 20/293 (6.8%) | 22 | 22/418 (5.3%) | 27 |
| Nasal congestion | 21/407 (5.2%) | 22 | 4/293 (1.4%) | 4 | 13/418 (3.1%) | 13 |
| Rhinorrhoea | 33/407 (8.1%) | 40 | 19/293 (6.5%) | 20 | 29/418 (6.9%) | 33 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Sanofi Pasteur Inc. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
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