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Study of Two Doses of Menactra® or One Dose of Monovalent Meningococcal Group C Vaccine With Routine Immunizations

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ClinicalTrials.gov Identifier: NCT01359449
Recruitment Status : Completed
First Posted : May 24, 2011
Results First Posted : May 24, 2013
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Interventions Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®
Biological: Meningococcal Group C Conjugate vaccine: MenC
Enrollment 123
Recruitment Details Study participants were enrolled from 19 May 2011 through 14 September 2011 in one clinic site in Canada.
Pre-assignment Details A total of 123 participants that met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age) Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Period Title: Overall Study
Started 61 62
Completed 57 58
Not Completed 4 4
Reason Not Completed
Lost to Follow-up             1             0
Protocol Violation             0             2
Withdrawal by Subject             3             2
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group Total
Hide Arm/Group Description Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age) Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule. Total of all reporting groups
Overall Number of Baseline Participants 61 62 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
<=18 years
61
 100.0%
62
 100.0%
123
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 61 participants 62 participants 123 participants
12.4  (0.3) 12.4  (0.3) 12.4  (0.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 62 participants 123 participants
Female
34
  55.7%
33
  53.2%
67
  54.5%
Male
27
  44.3%
29
  46.8%
56
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 61 participants 62 participants 123 participants
61 62 123
1.Primary Outcome
Title Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Hide Description Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers of Serum Bovine Albumin Baby Rabbit titers were determined in the per protocol population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 55 62
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (at age13 months, N = 0, 60)
NA [1] 
(NA to NA)
4.34
(3.69 to 5.10)
Serogroup A (at age 19 months, N = 51, 58)
1740
(1301 to 2327)
4.35
(3.76 to 5.03)
Serogroup C (at age 13 months, N = 0, 60)
NA [1] 
(NA to NA)
71.0
(39.3 to 128)
Serogroup C (at age 19 months, N = 51, 58)
957
(594 to 1540)
11.0
(6.75 to 18.1)
Serogroup Y (at age 13 months, N = 0, 60)
NA [1] 
(NA to NA)
31.3
(19.6 to 50.0)
Serogroup Y (at age 19 months, N = 51, 58)
719
(553 to 935)
67.1
(38.4 to 117)
Serogroup W-135 (at age 13 months, N = 0, 60)
NA [1] 
(NA to NA)
5.28
(4.13 to 6.74)
Serogroup W-135 (at age 19 months, N = 51, 58)
970
(686 to 1371)
7.36
(5.24 to 10.3)
[1]
Data not determined for this group at this time point as per protocol.
2.Primary Outcome
Title Number of Participants With Serum Bovine Albumin Baby Rabbit Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Hide Description Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity using Serum Bovine Albumin Baby Rabbit titers were determined in the per-protocol population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Unit of Measure: Participants
Serogroup A (at age 13 months; N = 0, 60) NA [1]  1
Serogroup A (at age 19 months; N = 51, 58) 51 2
Serogroup C (at age 13 months; N = 0, 60) NA [1]  40
Serogroup C (at age 19 months; N = 51, 58) 49 15
Serogroup Y (at age 13 months; N = 0, 60) NA [1]  36
Serogroup Y (at age 19 months; N = 51, 58) 51 39
Serogroup W-135 (at age 13 months; N = 0, 60) NA [1]  5
Serogroup W-135 (at age 19 months; N = 51, 58) 50 11
[1]
Data not determined for this group at this time point as per protocol.
3.Secondary Outcome
Title Geometric Mean Titers of Serum Bovine Albumin Human Complement Titers Following Vaccination With Either One Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Hide Description Immunogenicity tests were performed at 19 months of age in Menactra Vaccine Group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate Vaccine Group after Menjugate® vaccination.
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers of Serum Bovine Albumin Human Complement titers were determined in the per-protocol population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 55 62
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A (at age 13 months, N = 0, 44)
NA [1] 
(NA to NA)
2.23
(2.04 to 2.44)
Serogroup A (at age 19 months, N = 49, 48)
71.7
(48.2 to 107)
2.21
(2.00 to 2.45)
Serogroup C (at age 13 months, N = 0, 50)
NA [1] 
(NA to NA)
17.4
(11.6 to 26.1)
Serogroup C (at age 19 months, N = 49, 53)
219
(152 to 315)
6.93
(4.53 to 10.6)
Serogroup Y (at age 13 months, N = 0, 45)
NA [1] 
(NA to NA)
2.00
(2.0 to 2.0)
Serogroup Y (at age 19 months, N = 49, 53)
299
(222 to 403)
2.14
(1.98 to 2.31)
Serogroup W-135 (at age 13 months, N = 0, 45)
NA [1] 
(NA to NA)
2.06
(1.97 to 2.15)
Serogroup W-135 (at age 19 months, N = 49, 50)
207
(146 to 295)
2.17
(2.01 to 2.34)
[1]
Data not determined for this group at this time point as per protocol.
4.Secondary Outcome
Title Number of Participants With Serum Bovine Albumin Human Complement Titers of ≥ 1:8 Following Vaccination With Either a Dose of Menactra® Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate® Vaccine at 12 Months of Age.
Hide Description Immunogenicity tests were performed at 19 months of age in Menactra vaccine group after Menactra® vaccination and performed at 13 months and 19 months of age in the Menjugate vaccine group after Menjugate® vaccination
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Immunogenicity using Serum Bovine Albumin Human Complement titers were determined in the per-protocol population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 55 62
Measure Type: Number
Unit of Measure: Participants
Serogroup A (at age 13 months; N = 0, 44) NA [1]  1
Serogroup A (at age 19 months; N = 49, 48) 48 1
Serogroup C (at age 13 months; N = 0, 50) NA [1]  39
Serogroup C (at age 19 months; N = 49, 53) 49 21
Serogroup Y (at age 13 months; N = 0, 45) NA [1]  0
Serogroup Y (at age 19 months; N = 49, 53) 49 2
Serogroup W-135 (at age 13 months; N = 0, 45) NA [1]  0
Serogroup W-135 (at age 19 months; N = 49, 50) 48 1
[1]
Data not determined for this group at this time point as per protocol.
5.Secondary Outcome
Title Geometric Mean Titers of Antibodies to Pediacel® Vaccine Antigens in Participants That Received a Dose of Menactra® at 12 and 18 Months of Age, Respectively, and a Booster Dose of Pediacel® Vaccine at 18 Months of Age.
Hide Description Immunogenicity tests were performed at 18 and 19 months of age, respectively, before and after Pediacel® vaccination in the Menactra vaccine group
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers of of Pediacel vaccine antigens were determined in the per-protocol population of the Menactra® vaccine group.
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 51 62
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Diphtheria (at age 18 months; N = 46, 0)
0.420
(0.283 to 0.622)
NA [1] 
(NA to NA)
Diphtheria (at age 19 months; N = 46, 0)
7.81
(6.03 to 10.1)
NA [1] 
(NA to NA)
Tetanus (at age 18 months; N = 44, 0)
0.485
(0.365 to 0.644)
NA [1] 
(NA to NA)
Tetanus (at age 19 months; N = 47, 0)
8.71
(7.02 to 10.8)
NA [1] 
(NA to NA)
PRP (at age 18 months; N = 44, 0)
0.500
(0.306 to 0.818)
NA [1] 
(NA to NA)
PRP (at age 19 months; N = 46, 0)
46.3
(32.2 to 66.4)
NA [1] 
(NA to NA)
Polio Type 1 (at age 18 months; N = 45, 0)
138
(95.2 to 201)
NA [1] 
(NA to NA)
Polio Type 1 (at age 19 months; N = 46, 0)
4552
(3436 to 6029)
NA [1] 
(NA to NA)
Polio Type 2 (at age 18 months; N = 39, 0)
203
(127 to 324)
NA [1] 
(NA to NA)
Polio Type 2 (at age 19 months; N = 46, 0)
6889
(5250 to 9039)
NA [1] 
(NA to NA)
Polio Type 3 (at age 18 months; N = 38, 0)
133
(84.2 to 209)
NA [1] 
(NA to NA)
Polio Type 3 (at age 19 months; N = 45, 0)
5322
(3705 to 7645)
NA [1] 
(NA to NA)
Pertussis Toxoid (at age 18 months; N = 45, 0)
8.61
(6.39 to 11.6)
NA [1] 
(NA to NA)
Pertussis Toxoid (at age 19 months; N = 47, 0)
162
(132 to 199)
NA [1] 
(NA to NA)
Filamentous hemagglutinin (age 18 months; N=45, 0)
19.9
(14.1 to 28.2)
NA [1] 
(NA to NA)
Filamentous hemagglutinin (age 19 months; N=47, 0)
239
(182 to 315)
NA [2] 
(NA to NA)
Pertactin (at age 18 months; N = 44, 0)
8.45
(6.46 to 11.0)
NA [1] 
(NA to NA)
Pertactin (at age 19 months; N = 45, 0)
123
(90.7 to 165)
NA [1] 
(NA to NA)
Fimbriae types 2 and 3 (age 18 months; N = 45, 0)
35.7
(26.4 to 48.3)
NA [1] 
(NA to NA)
Fimbriae types 2 and 3 (age 19 months; N = 45, 0)
622
(425 to 911)
NA [1] 
(NA to NA)
[1]
Participants in this group did not receive Pediacel® vaccine in this study.
[2]
Participants in this group did not receive Pediacel vaccine in this study.
6.Secondary Outcome
Title Summary of Participants With Booster Response for Pediacel® Vaccine Antigens After Vaccination With Pediacel® Vaccine (Menactra Vaccine Group)
Hide Description Pediacel vaccine administered only to the Menactra Vaccine Group. Booster response was defined as subjects with pre-dose titers < 4xLLOQ and have a 4-fold rise rate; or subjects with pre-dose titers ≥ 4xLLOQ and have a 2-fold rise rate
Time Frame 28 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Pediacel® vaccine antigen booster responses were determined in the per-protocol population of the Menactra® vaccine group
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 51 62
Measure Type: Number
Unit of Measure: Participants
Pertussis toxoid (N = 44, 0) 44 NA [1] 
Filamentous hemagglutinin (N = 44, 0) 43 NA [1] 
Pertactin (N = 41, 0) 38 NA [1] 
Fimbriae types 2 and 3 (N = 42, 0) 42 NA [1] 
[1]
Participants in this group did not receive Pediacel® vaccine in this study.
7.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With Either a Dose of Menactra Vaccine at 12 and 18 Months of Age, Respectively, or One Single Dose of Menjugate Vaccine at 12 Months of Age
Hide Description

Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.

Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants, intent-to-treat population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: Participants
Any injection site Tenderness 21 21
Grade 3 injection site Tenderness 0 0
Any injection site Erythema 26 23
Grade 3 injection site Erythema 0 0
Any injection site Swelling 9 8
Grade 3 injection site Swelling 0 0
Any Fever 30 18
Grade 3 Fever 1 0
Any Vomiting 5 7
Grade 3 Vomiting 0 0
Any Crying abnormal 25 22
Grade 3 Crying abnormal 0 0
Any Drowsiness 22 12
Grade 3 Drowsiness 0 0
Any Appetite lost 28 24
Grade 3 Appetite lost 0 0
Any Irritability 43 40
Grade 3 Irritability 1 1
8.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With a Second Dose of Menactra Vaccine at 18 Months of Age
Hide Description

Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.

Grade 3 reactions defined as: Tenderness - Cries when injected limb is moved, or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 50 mm; Fever - > 39.5°C; Vomiting - ≥ 6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal - > 3 hours; Drowsiness - Sleeping most of the time or difficult to wake up; Appetite lost - Refuses ≥ 3 feeds/meals or refuses most feeds/meals, and Irritability - Inconsolable.

Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: Participants
Any injection site Tenderness 30 NA [1] 
Grade 3 injection site Tenderness 2 NA [1] 
Any injection site Erythema 19 NA [1] 
Grade 3 injection site Erythema 1 NA [1] 
Any injection site Swelling 11 NA [1] 
Grade 3 injection site Swelling 0 NA [1] 
Any Fever 21 NA [1] 
Grade 3 Fever 3 NA [1] 
Any Vomiting 6 NA [1] 
Grade 3 Vomiting 1 NA [1] 
Any Crying abnormal 25 NA [1] 
Grade 3 Crying abnormal 1 NA [1] 
Any Drowsiness 20 NA [1] 
Grade 3 Drowsiness 1 NA [1] 
Any Appetite lost 32 NA [1] 
Grade 3 Appetite lost 1 NA [1] 
Any Irritability 40 NA [1] 
Grade 3 Irritability 2 NA [1] 
[1]
Participants in this group did not receive a second dose of a meningococcal vaccine in this study.
9.Secondary Outcome
Title Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Any of the Study Vaccination
Hide Description Solicited Injection site: Tenderness, Erythema and Swelling: Solicited Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site and systemic reactions were assessed in all enrolled and vaccinated participants in the Menactra vaccine group, intent to treat population
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description:
Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
Overall Number of Participants Analyzed 60 62
Measure Type: Number
Unit of Measure: Participants
Any injection site Tenderness 36 21
Any injection site Erythema 32 23
Any injection site Swelling 18 8
Any Fever 44 18
Any Vomiting 10 7
Any Crying abnormal 31 22
Any Drowsiness 31 12
Any Appetite lost 45 24
Any Irritability 50 40
Time Frame Adverse events were assessed from Day 0 (post-vaccination) up to 6 months post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Vaccine Group Menjugate® Vaccine Group
Hide Arm/Group Description Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age) Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
All-Cause Mortality
Menactra® Vaccine Group Menjugate® Vaccine Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Vaccine Group Menjugate® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/61 (1.64%)      2/62 (3.23%)    
Infections and infestations     
Bronchiolitis * 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Musculoskeletal and connective tissue disorders     
Rickets * 1  0/61 (0.00%)  0 1/62 (1.61%)  1
Nervous system disorders     
Febrile convulsion * 1  1/61 (1.64%)  1 0/62 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Menactra® Vaccine Group Menjugate® Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   50/61 (81.97%)      40/62 (64.52%)    
Gastrointestinal disorders     
Diarrhoea * 1  5/61 (8.20%)  6 6/62 (9.68%)  6
Teething * 1  13/61 (21.31%)  13 9/62 (14.52%)  10
Vomiting  1  10/61 (16.39%)  10 7/62 (11.29%)  7
General disorders     
Irritability * 1  4/61 (6.56%)  6 0/62 (0.00%)  0
Pyrexia * 1  15/61 (24.59%)  20 14/62 (22.58%)  15
Pyrexia  1  30/61 (49.18%)  30 18/62 (29.03%)  18
Injection site Tenderness  1  36/61 (59.02%)  36 21/62 (33.87%)  21
Injection site Erythema  1  32/61 (52.46%)  32 23/62 (37.10%)  23
Injection site Swelling  1  18/61 (29.51%)  18 8/62 (12.90%)  8
Infections and infestations     
Nasopharyngitis * 1  14/61 (22.95%)  19 8/62 (12.90%)  8
Otitis media * 1  7/61 (11.48%)  9 0/62 (0.00%)  0
Roseola * 1  3/61 (4.92%)  3 0/62 (0.00%)  0
Sinusitis * 1  3/61 (4.92%)  3 0/62 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  45/61 (73.77%)  45 24/62 (38.71%)  24
Nervous system disorders     
Somnolence  1  31/61 (50.82%)  31 12/62 (19.35%)  12
Psychiatric disorders     
Irritability  1  50/61 (81.97%)  50 40/62 (64.52%)  40
Crying  1  31/61 (50.82%)  31 22/62 (35.48%)  22
Respiratory, thoracic and mediastinal disorders     
Cough * 1  4/61 (6.56%)  4 1/62 (1.61%)  2
Nasal congestion * 1  5/61 (8.20%)  5 0/62 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis * 1  4/61 (6.56%)  5 1/62 (1.61%)  1
Rash maculo papular * 1  7/61 (11.48%)  7 4/62 (6.45%)  4
Rash papular * 1  4/61 (6.56%)  5 0/62 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
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Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
EMail: RegistryContactUs@sanofipasteur.com
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Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01359449     History of Changes
Other Study ID Numbers: MTA73
U1111-1117-7073 ( Other Identifier: WHO )
First Submitted: May 23, 2011
First Posted: May 24, 2011
Results First Submitted: April 4, 2013
Results First Posted: May 24, 2013
Last Update Posted: August 19, 2016