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Trial record 1 of 1 for:    MTA44
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A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT00384397
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : June 2, 2011
Last Update Posted : April 14, 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: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Meningococcal Meningitis
Measles
Mumps
Rubella
Varicella
Interventions Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Enrollment 1128
Recruitment Details Participants were enrolled from 20 September 2006 to 29 September 2007 at 71 US clinical centers.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Adverse Event             0             1             2
Protocol Violation             7             15             13
Lost to Follow-up             11             13             3
Withdrawal by Subject             14             17             15
Arm/Group Title Group 1: Menactra® Vaccine Group 2: Menactra® + MMRV Group 3: Menactra® + PCV Total
Hide 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 Number of Baseline Participants 407 293 418 1118
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 407 participants 293 participants 418 participants 1118 participants
<=18 years
407
 100.0%
293
 100.0%
418
 100.0%
1118
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 407 participants 293 participants 418 participants 1118 participants
278.7  (10.55) 279.8  (10.93) 279.5  (11.11) 279.3  (10.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 407 participants 293 participants 418 participants 1118 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 407 participants 293 participants 418 participants 1118 participants
407 293 418 1118
1.Primary Outcome
Title Percentage of Participants With Antibody Titers ≥ 8 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Hide Description [Not Specified]
Time Frame 30 days post-visit 2 Menactra®
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 277 180 267
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A 96 93 91
Meningococcal Serogroup C 100 99 98
Meningococcal Serogroup Y 96 97 95
Meningococcal Serogroup W-135 86 88 81
2.Secondary Outcome
Title Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 407 293 418
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction Post-Dose 1 41 48 43
Any Tenderness 32 35 32
Grade 3 Tenderness (Cries when limb is moved) 1 0 0
Any Erythema 22 25 22
Grade 3 Erythema (≥ 2.0 in) 1 1 2
Any Swelling 11 15 11
Grade 3 Swelling (≥ 2.0 in) 0 2 1
Any Solicited Injection Site Reaction Post-Dose 2 43 49 54
Any Tenderness - Menactra Site 36 39 48
Grade 3 Tenderness (Cries when limb is moved) 0 1 1
Any Erythema - Menactra Site 23 26 27
Grade 3 Erythema (≥ 2.0 in) - Menactra Site 1 2 3
Any Swelling - Menactra Site 10 14 17
Grade 3 Swelling (≥ 2.0 in) - Menactra Site 1 3 2
Any Tenderness - MMRV Site 0 37 0
Gr 3 Tenderness (Cries when limb moved) MMRV Site 0 1 0
Any Erythema - MMRV Site 0 23 0
Grade 3 Erythema (≥ 2.0 in) - MMRV Site 0 3 0
Any Swelling - MMRV Site 0 12 0
Grade 3 Swelling (≥ 2.0 in) - MMRV Site 0 2 0
Any Tenderness - PCV Site 0 0 47
Gr 3 Tenderness (Cries when limb moved) PCV Site 0 0 1
Any Erythema - PCV Site 0 0 30
Grade 3 Erythema (≥ 2.0 in) - PCV Site 0 0 4
Any Swelling - PCV Site 0 0 20
Grade 3 Swelling (≥ 2.0 in) 0 0 3
Any Solicited Systemic Reaction Post-Dose 1 68 64 67
Any Fever (Any Route) 13 12 13
Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) 1 2 2
Any Vomiting 16 14 15
Grade 3 Vomiting (≥ 6 episodes per 24 hr) 1 0 0
Any Crying Abnormal 34 36 33
Grade 3 Crying Abnormal (> 3 hours) 2 2 1
Any Drowsiness 31 30 30
Grade 3 Drowsiness (Sleeps most of time) 1 1 0
Any Appetite Lost 25 26 27
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) 1 0 0
Any Irritability 55 57 53
Grade 3 Irritability (Inconsolable) 2 2 2
Any Solicited Systemic Reaction Post-Dose 2 64 74 68
Any Fever (Any Route) 16 26 22
Grade 3 Fever (Any Route > 103.1 ºF or > 39.5 ºC) 1 4 1
Any Vomiting 7 10 11
Grade 3 Vomiting (≥ 6 episodes per 24 hr) 1 1 0
Any Crying Abnormal 35 39 38
Grade 3 Crying Abnormal (> 3 hours) 2 1 5
Any Drowsiness 28 32 33
Grade 3 Drowsiness (Sleeps most of time) 1 1 1
Any Appetite Lost 26 32 32
Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) 2 2 2
Any Irritability 52 61 57
Grade 3 Irritability (Inconsolable) 3 3 5
3.Other Pre-specified Outcome
Title Percentage of Participants With Antibody Titers ≥ 4 After Visit 2 Menactra® Vaccination as Measured by Serum Bactericidal Assay Using Human Complement (SBA-HC)
Hide Description [Not Specified]
Time Frame 30 days post-Visit 2 Menactra®
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 277 180 267
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal Serogroup A 98 98 97
Meningococcal Serogroup C 100 100 99
Meningococcal Serogroup Y 99 99 98
Meningococcal Serogroup W-135 93 96 91
4.Other Pre-specified Outcome
Title Meningococcal Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers Following Visit 2 Vaccination(s) at 12 Months.
Hide Description [Not Specified]
Time Frame 30 days post-Visit 2 Menactra®
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 277 180 267
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A
54.9
(46.8 to 64.5)
52
(41.8 to 64.7)
41
(34.6 to 48.5)
Meningococcal Serogroup C
141.8
(123.5 to 162.9)
161.9
(136.3 to 192.3)
109.5
(94.1 to 127.5)
Meningococcal Serogroup Y
52.4
(45.4 to 60.6)
60.2
(50.4 to 71.7)
39.9
(34.4 to 46.2)
Meningococcal Serogroup W-135
24.3
(20.8 to 28.3)
27.9
(22.7 to 34.3)
17.9
(15.2 to 21)
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 [Not Specified]
 
Arm/Group Title Group 1: Menactra® Vaccine Group 2: Menactra® + MMRV Group 3: Menactra® + PCV
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 (3.93%)      9/293 (3.07%)      17/418 (4.07%)    
Blood and lymphatic system disorders       
Autoimmune neutropenia * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
Gastrointestinal disorders       
Barrett's esophagus * 1  0/407 (0.00%)  0 1/293 (0.34%)  1 0/418 (0.00%)  0
Inguinal hernia * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 0/418 (0.00%)  0
Intussusception * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 0/418 (0.00%)  0
General disorders       
Pyrexia * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
Infections and infestations       
Bronchiolitis * 1  1/407 (0.25%)  1 3/293 (1.02%)  3 1/418 (0.24%)  1
Cellulitis * 1  1/407 (0.25%)  1 1/293 (0.34%)  1 0/418 (0.00%)  0
Condyloma acuminatum * 1  0/407 (0.00%)  0 1/293 (0.34%)  1 0/418 (0.00%)  0
Escherichia bacteraemia * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
Febrile infection * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 0/418 (0.00%)  0
Gastroenteritis * 1  0/407 (0.00%)  0 1/293 (0.34%)  1 3/418 (0.72%)  3
Pneumococcal sepsis * 1  0/407 (0.00%)  0 1/293 (0.34%)  1 0/418 (0.00%)  0
Pneumonia * 1  2/407 (0.49%)  2 0/293 (0.00%)  0 0/418 (0.00%)  0
Pneumonia respiratory syncytial viral * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 1/418 (0.24%)  1
Pneumonia viral * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 0/418 (0.00%)  0
Pyelonephritis * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 1/418 (0.24%)  1
Staphylococcal abscess * 1  2/407 (0.49%)  2 0/293 (0.00%)  0 1/418 (0.24%)  1
Streptococcal bacteraemia * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
Injury, poisoning and procedural complications       
Exposure to toxic agent * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 0/418 (0.00%)  0
Skull fractured base * 1  0/407 (0.00%)  0 1/293 (0.34%)  1 0/418 (0.00%)  0
Metabolism and nutrition disorders       
Diabetes mellitus insulin-dependent * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
Nervous system disorders       
Convulsion * 1  1/407 (0.25%)  1 0/293 (0.00%)  0 0/418 (0.00%)  0
Febrile convulsion * 1  2/407 (0.49%)  5 0/293 (0.00%)  0 3/418 (0.72%)  3
Respiratory, thoracic and mediastinal disorders       
Asthma * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
Pneumonitis * 1  0/407 (0.00%)  0 0/293 (0.00%)  0 1/418 (0.24%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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 (51.60%)      137/293 (46.76%)      222/418 (53.11%)    
Gastrointestinal disorders       
Diarrhoea * 1  38/407 (9.34%)  41 29/293 (9.90%)  38 40/418 (9.57%)  48
Teething * 1  56/407 (13.76%)  75 34/293 (11.60%)  54 43/418 (10.29%)  64
General disorders       
Pyrexia * 1  32/407 (7.86%)  36 21/293 (7.17%)  24 37/418 (8.85%)  40
Infections and infestations       
Nasopharyngitis * 1  29/407 (7.13%)  32 15/293 (5.12%)  17 18/418 (4.31%)  21
Otitis media * 1  69/407 (16.95%)  81 48/293 (16.38%)  55 85/418 (20.33%)  96
Upper respiratory tract infection * 1  47/407 (11.55%)  53 33/293 (11.26%)  37 81/418 (19.38%)  90
Respiratory, thoracic and mediastinal disorders       
Cough * 1  37/407 (9.09%)  37 20/293 (6.83%)  22 22/418 (5.26%)  27
Nasal congestion * 1  21/407 (5.16%)  22 4/293 (1.37%)  4 13/418 (3.11%)  13
Rhinorrhoea * 1  33/407 (8.11%)  40 19/293 (6.48%)  20 29/418 (6.94%)  33
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00384397     History of Changes
Other Study ID Numbers: MTA44
First Submitted: October 5, 2006
First Posted: October 6, 2006
Results First Submitted: May 10, 2011
Results First Posted: June 2, 2011
Last Update Posted: April 14, 2016