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Trial record 9 of 10 for:    Menomune A/C/Y/W 135

Study of a Tetravalent Meningococcal Diphtheria Toxoid Conjugate Vaccine in Toddlers 9 to 18 Months of Age

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00643916
Recruitment Status : Completed
First Posted : March 26, 2008
Results First Posted : January 8, 2010
Last Update Posted : February 14, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Interventions Biological: Meningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Enrollment 378
Recruitment Details Participants were enrolled from 10 December 2004 to 14 May 2005 in 15 medical centers in the US
Pre-assignment Details A total of 378 participants that met the inclusion and exclusion criteria were enrolled, 369 were vaccinated.
Arm/Group Title Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Hide Arm/Group Description Participants received Menactra vaccine at 9 and 12 months of age Participants received Menactra vaccine at 9 months and 15 months of age Participants received Menactra vaccine at 12 months and 15 months of age Participants received Menactra vaccine at 15 months of age Participants received Menactra vaccine at 18 months of age Participants received Menomune vaccine at age 3 years to <6 years of age
Period Title: Overall Study
Started 55 67 68 62 59 67
Completed 51 61 62 60 57 66
Not Completed 4 6 6 2 2 1
Reason Not Completed
Protocol Violation             0             1             1             1             0             0
Lost to Follow-up             0             1             0             0             0             0
Withdrawal by Subject             2             2             2             1             0             1
Not Vaccinated             2             2             3             0             2             0
Arm/Group Title Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years Total
Hide Arm/Group Description Participants received Menactra vaccine at 9 and 12 months of age Participants received Menactra vaccine at 9 months and 15 months of age Participants received Menactra vaccine at 12 months and 15 months of age Participants received Menactra vaccine at 15 months of age Participants received Menactra vaccine at 18 months of age Participants received Menomune vaccine at age 3 years to <6 years of age Total of all reporting groups
Overall Number of Baseline Participants 55 67 68 62 59 67 378
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 67 participants 68 participants 62 participants 59 participants 67 participants 378 participants
<=18 years
55
 100.0%
67
 100.0%
68
 100.0%
62
 100.0%
59
 100.0%
67
 100.0%
378
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
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%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 55 participants 67 participants 68 participants 62 participants 59 participants 67 participants 378 participants
8.9  (0.4) 8.9  (0.3) 11.9  (0.3) 14.9  (0.3) 17.9  (0.3) 48.0  (10.3) 18.7  (14.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 67 participants 68 participants 62 participants 59 participants 67 participants 378 participants
Female
24
  43.6%
34
  50.7%
34
  50.0%
23
  37.1%
34
  57.6%
30
  44.8%
179
  47.4%
Male
31
  56.4%
33
  49.3%
34
  50.0%
39
  62.9%
25
  42.4%
37
  55.2%
199
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 67 participants 68 participants 62 participants 59 participants 67 participants 378 participants
55 67 68 62 59 67 378
1.Primary Outcome
Title Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Hide Description [Not Specified]
Time Frame Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
Arm/Group Title Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Hide Arm/Group Description:
Participants received Menactra vaccine at 9 and 12 months of age
Participants received Menactra vaccine at 9 months and 15 months of age
Participants received Menactra vaccine at 12 months and 15 months of age
Participants received Menactra vaccine at 15 months of age
Participants received Menactra vaccine at 18 months of age
Participants received Menomune vaccine at age 3 years to <6 years of age
Overall Number of Participants Analyzed 40 50 54 55 51 63
Measure Type: Number
Unit of Measure: Percentage of Participants
Meningococcal serogroup A (Baseline) 38 44 33 40 40 71
Meningococcal serogroup A (Post dose 1) 76 67 52 76 65 87
Meningococcal serogroup A (Post dose 2) 89 89 85 0 0 0
Meningococcal serogroup C (Baseline) 5 2 0 2 4 8
Meningococcal serogroup C (Post dose 1) 83 85 85 86 77 49
Meningococcal serogroup C (Post dose 2) 100 100 100 0 0 0
Meningococcal serogroup Y (Baseline) 3 0 2 2 8 8
Meningococcal serogroup Y (Post dose 1) 21 24 35 33 47 66
Meningococcal serogroup Y (Post dose 2) 95 94 96 0 0 0
Meningococcal serogroup W-135 (Baseline) 3 0 0 2 0 10
Meningococcal serogroup W-135 (Post dose 1) 24 27 18 42 36 61
Meningococcal serogroup W-135 (Post dose 2) 92 92 96 0 0 0
2.Other Pre-specified Outcome
Title Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Hide Description Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Time Frame Day 0 up to 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.
Arm/Group Title Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Hide Arm/Group Description:
Participants received Menactra vaccine at 9 and 12 months of age
Participants received Menactra vaccine at 9 months and 15 months of age
Participants received Menactra vaccine at 12 months and 15 months of age
Participants received Menactra vaccine at 15 months of age
Participants received Menactra vaccine at 18 months of age
Participants received Menomune vaccine at age 3 years to <6 years of age
Overall Number of Participants Analyzed 53 65 65 62 57 67
Measure Type: Number
Unit of Measure: Percentage of participants
Any Solicited Injection Site Reaction-Any Dose 74 69 65 53 61 55
Any Solicited Injection Site Reaction - Dose 1 62 45 57 53 61 55
Grade 3 Solicited Injection Site Reaction - Dose 1 0 2 2 0 2 8
Any Erythema 32 20 34 37 39 33
Grade 3 Erythema (≥ 2 inches) 0 2 2 0 2 2
Any Swelling 23 8 15 15 23 12
Grade 3 Swelling (≥ 2 inches) 0 0 2 0 2 0
Any Tenderness 43 31 37 35 49 48
Grade 3 Tenderness (cries when inj. limb is moved) 0 0 0 0 0 6
Any Solicited Systemic Reaction-Any Dose 89 84 72 75 72 31
Any Solicited Systemic Reaction Dose 1 72 75 60 75 72 31
Grade 3 Solicited Systemic Reaction Dose 1 9 8 5 12 7 0
Any Fever 23 17 11 18 21 3
Grade 3 Fever (≥ 39.6 ºC) 2 3 0 3 0 0
Any Vomiting 17 20 11 8 11 5
Grade 3 Vomiting (≥ 6 episodes per day) 4 0 0 3 0 0
Any Crying Abnormal 34 36 28 30 19 13
Grade 3 Crying Abnormal (> 3 hours) 4 3 2 2 2 0
Any Drowsiness 40 38 31 35 37 18
Grade 3 Drowsiness (difficulty to wake up) 4 0 0 0 4 0
Any Appetite Lost 28 36 28 37 35 13
Grade 3 Appetite Lost (refuses ≥ 3 feeds) 4 2 5 5 0 0
Any Irritability 60 61 49 57 51 22
Grade 3 Irrtability (inconsolable) 4 5 3 3 5 0
Any Solicited Injection Site Reaction - Dose 2 63 54 48 0 0 0
Grade 3 Solicited Injection Site Reaction - Dose 2 2 7 0 0 0 0
Any Erythema 29 36 23 0 0 0
Grade 3 Erythema (≥ 2 inches) 0 2 0 0 0 0
Any Swelling 25 20 11 0 0 0
Grade 3 Swelling (≥ 2 inches) 0 3 0 0 0 0
Any Tenderness 52 42 37 0 0 0
Grade 3 Tenderness (cries when inj. limb is moved) 2 3 0 0 0 0
Any Solicited Systemic Reaction Dose 2 83 56 53 0 0 0
Grade 3 Solicited Systemic Reaction Dose 2 13 9 5 0 0 0
Any Fever 28 15 10 0 0 0
Grade 3 Fever (≥ 39.6 ºC) 2 0 0 0 0 0
Any Vomiting 19 10 8 0 0 0
Grade 3 Vomiting ≥ 6 episodes per day) 0 2 0 0 0 0
Any Crying Abnormal 50 29 27 0 0 0
Grade 3 Crying Abnormal (> 3 hours) 6 2 2 0 0 0
Any Drowsiness 42 25 18 0 0 0
Grade 3 Drowsiness (difficulty to wake up) 0 2 0 0 0 0
Any Appetite Lost 31 32 29 0 0 0
Grade 3 Appetite Lost (refuses ≥ 3 feeds) 0 3 0 0 0 0
Any Irritability 63 42 44 0 0 0
Grade 3 Irritability (inconsolable) 10 7 5 0 0 0
Time Frame Adverse events data were collected for 6 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Hide Arm/Group Description Participants received Menactra vaccine at 9 and 12 months of age Participants received Menactra vaccine at 9 months and 15 months of age Participants received Menactra vaccine at 12 months and 15 months of age Participants received Menactra vaccine at 15 months of age Participants received Menactra vaccine at 18 months of age Participants received Menomune vaccine at age 3 years to <6 years of age
All-Cause Mortality
Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      3/65 (4.62%)      4/65 (6.15%)      1/61 (1.64%)      5/57 (8.77%)      3/67 (4.48%)    
Blood and lymphatic system disorders             
Granulocytopenia * 1  0/53 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0 0/57 (0.00%)  0 0/67 (0.00%)  0
Gastrointestinal disorders             
Appendicitis perforated * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 1/57 (1.75%)  1 0/67 (0.00%)  0
Infections and infestations             
Abscess * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 0/57 (0.00%)  0 1/67 (1.49%)  1
Abscess limb * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 1/65 (1.54%)  1 0/61 (0.00%)  0 0/57 (0.00%)  0 0/67 (0.00%)  0
Bronchiolitis * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 1/65 (1.54%)  1 1/61 (1.64%)  1 0/57 (0.00%)  0 0/67 (0.00%)  0
Cellulitis * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 0/57 (0.00%)  0 1/67 (1.49%)  1
Clostridial infection * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 1/65 (1.54%)  1 0/61 (0.00%)  0 0/57 (0.00%)  0 0/67 (0.00%)  0
Croup infectious * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 1/65 (1.54%)  1 0/61 (0.00%)  0 0/57 (0.00%)  0 0/67 (0.00%)  0
Gastroenteritis rotavirus * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 0/57 (0.00%)  0 1/67 (1.49%)  1
Gastroenteritis viral * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 1/57 (1.75%)  1 0/67 (0.00%)  0
Pneumonia adenoviral * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 1/61 (1.64%)  1 0/57 (0.00%)  0 0/67 (0.00%)  0
Injury, poisoning and procedural complications             
Contusion * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 1/57 (1.75%)  1 0/67 (0.00%)  0
Femur fracture * 1  0/53 (0.00%)  0 0/65 (0.00%)  0 0/65 (0.00%)  0 0/61 (0.00%)  0 1/57 (1.75%)  1 0/67 (0.00%)  0
Nervous system disorders             
Convulsion * 1  0/53 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0 0/57 (0.00%)  0 0/67 (0.00%)  0
Febrile convulsion * 1  0/53 (0.00%)  0 1/65 (1.54%)  1 0/65 (0.00%)  0 0/61 (0.00%)  0 1/57 (1.75%)  1 0/67 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vaccinated at Age 9 and 12 Months Vaccinated at Age 9 and 15 Months Vaccinated at Age 12 and 15 Months Vaccinated at Age 15 Months Vaccinated at Age 18 Months Vaccinated at Age 3 Years to <6 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   37/53 (69.81%)      50/65 (76.92%)      48/65 (73.85%)      34/61 (55.74%)      33/57 (57.89%)      21/67 (31.34%)    
Eye disorders             
Conjunctivitis * 1  1/53 (1.89%)  1 3/65 (4.62%)  3 2/65 (3.08%)  2 3/61 (4.92%)  3 3/57 (5.26%)  4 1/67 (1.49%)  1
Gastrointestinal disorders             
Diarrhoea * 1  9/53 (16.98%)  12 13/65 (20.00%)  18 8/65 (12.31%)  9 6/61 (9.84%)  7 8/57 (14.04%)  9 2/67 (2.99%)  2
Teething * 1  8/53 (15.09%)  10 13/65 (20.00%)  22 17/65 (26.15%)  23 5/61 (8.20%)  6 5/57 (8.77%)  5 0/67 (0.00%)  0
Vomiting * 1  3/53 (5.66%)  3 4/65 (6.15%)  5 3/65 (4.62%)  3 2/61 (3.28%)  2 3/57 (5.26%)  3 0/67 (0.00%)  0
General disorders             
Injection site haemorrhage * 1  3/53 (5.66%)  3 9/65 (13.85%)  9 7/65 (10.77%)  9 0/61 (0.00%)  0 4/57 (7.02%)  4 7/67 (10.45%)  7
Pyrexia * 1  6/53 (11.32%)  6 13/65 (20.00%)  16 7/65 (10.77%)  8 3/61 (4.92%)  3 7/57 (12.28%)  7 4/67 (5.97%)  4
Infections and infestations             
Otitis media * 1  3/53 (5.66%)  3 13/65 (20.00%)  15 6/65 (9.23%)  6 5/61 (8.20%)  5 4/57 (7.02%)  4 1/67 (1.49%)  1
Otitis media acute * 1  3/53 (5.66%)  3 3/65 (4.62%)  3 3/65 (4.62%)  3 1/61 (1.64%)  1 2/57 (3.51%)  2 0/67 (0.00%)  0
Rhinitis * 1  2/53 (3.77%)  2 2/65 (3.08%)  2 3/65 (4.62%)  3 4/61 (6.56%)  4 2/57 (3.51%)  2 1/67 (1.49%)  1
Sinusitis * 1  2/53 (3.77%)  2 0/65 (0.00%)  0 4/65 (6.15%)  4 0/61 (0.00%)  0 0/57 (0.00%)  0 0/67 (0.00%)  0
Upper respiratory tract infection * 1  6/53 (11.32%)  6 13/65 (20.00%)  13 8/65 (12.31%)  9 6/61 (9.84%)  6 5/57 (8.77%)  5 2/67 (2.99%)  2
Respiratory, thoracic and mediastinal disorders             
Cough * 1  13/53 (24.53%)  15 12/65 (18.46%)  14 12/65 (18.46%)  16 7/61 (11.48%)  7 7/57 (12.28%)  7 9/67 (13.43%)  9
Nasal congestion * 1  6/53 (11.32%)  7 7/65 (10.77%)  7 5/65 (7.69%)  8 0/61 (0.00%)  0 5/57 (8.77%)  5 5/67 (7.46%)  5
Rhinorrhoea * 1  7/53 (13.21%)  9 6/65 (9.23%)  6 10/65 (15.38%)  12 7/61 (11.48%)  7 2/57 (3.51%)  2 4/67 (5.97%)  4
Wheezing * 1  0/53 (0.00%)  0 4/65 (6.15%)  4 0/65 (0.00%)  0 1/61 (1.64%)  1 0/57 (0.00%)  0 0/67 (0.00%)  0
Skin and subcutaneous tissue disorders             
Dermatitis diaper * 1  1/53 (1.89%)  1 6/65 (9.23%)  6 3/65 (4.62%)  4 3/61 (4.92%)  3 0/57 (0.00%)  0 0/67 (0.00%)  0
Rash * 1  4/53 (7.55%)  4 3/65 (4.62%)  3 4/65 (6.15%)  4 0/61 (0.00%)  0 3/57 (5.26%)  3 0/67 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 7.1
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: NCT00643916     History of Changes
Other Study ID Numbers: MTA26
First Submitted: March 24, 2008
First Posted: March 26, 2008
Results First Submitted: September 24, 2009
Results First Posted: January 8, 2010
Last Update Posted: February 14, 2014