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Trial record 1 of 1 for:    MTA61
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Dose Comparison Study of Menactra® in US Children

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ClinicalTrials.gov Identifier: NCT00700635
Recruitment Status : Completed
First Posted : June 19, 2008
Results First Posted : December 23, 2010
Last Update Posted : April 14, 2016
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
Neisseria Meningitidis
Intervention Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Conjugate
Enrollment 333
Recruitment Details Participants were enrolled from 17 June 2008 to 25 July 2008 in 13 of 15 medical centers in the US.
Pre-assignment Details A total of 333 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description Participants aged 2 to less than 4 years who received 2 doses of vaccine Participants aged 4 to less than 6 years who received 2 doses of vaccine Participants aged 6 to less than 11 years who received a single dose of vaccine
Period Title: Overall Study
Started 111 111 111
Completed 100 103 110
Not Completed 11 8 1
Reason Not Completed
Adverse Event             1             0             0
Lost to Follow-up             1             3             0
Protocol Violation             2             2             0
Withdrawal by Subject             7             3             1
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3 Total
Hide Arm/Group Description Participants aged 2 to less than 4 years who received 2 doses of vaccine Participants aged 4 to less than 6 years who received 2 doses of vaccine Participants aged 6 to less than 11 years who received a single dose of vaccine Total of all reporting groups
Overall Number of Baseline Participants 111 111 111 333
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 111 participants 333 participants
<=18 years
111
 100.0%
111
 100.0%
111
 100.0%
333
 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:  Years
Age Continuous Number Analyzed 111 participants 111 participants 111 participants 333 participants
2.46  (0.5) 4.46  (0.5) 8.05  (1.31) 4.99  (2.47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 111 participants 333 participants
Female
50
  45.0%
55
  49.5%
53
  47.7%
158
  47.4%
Male
61
  55.0%
56
  50.5%
58
  52.3%
175
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 111 participants 111 participants 333 participants
111 111 111 333
1.Primary Outcome
Title Percentage of Participants With Meningococcal Antibody Titers ≥ 8 After Each Vaccination
Hide Description Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time Frame 30 days post-vaccination
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 were evaluated in the per-protocol population.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description:
Participants aged 2 to less than 4 years who received 2 doses of vaccine
Participants aged 4 to less than 6 years who received 2 doses of vaccine
Participants aged 6 to less than 11 years who received a single dose of vaccine
Overall Number of Participants Analyzed 82 89 108
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A Post-dose 1 ≥ 8 [n = 82, 89, 107] 59 36 65
Serogroup A Post-dose 2 ≥ 8 [n = 81, 89, 0] 83 67 NA [1] 
Serogroup C Post-dose 1 ≥ 8 [n = 82, 89, 108] 72 51 62
Serogroup C Post-dose 2 ≥ 8 [n = 82, 89, 0] 95 88 NA [1] 
Serogroup Y Post-dose 1 ≥ 8 [n = 82, 89, 108] 60 65 71
Serogroup Y Post-dose 2 ≥ 8 [n = 82, 89, 0] 100 96 NA [1] 
Serogroup W-135 Post-dose 1 ≥ 8 [n = 82, 89, 108] 66 79 91
Serogroup W-135 Post-dose 2 ≥ 8 [n = 82, 89, 0] 96 96 NA [1] 
[1]
Dose 2 vaccination was not administered to the Menactra Group 3
2.Secondary Outcome
Title Percentage of Participants With Meningococcal Antibody Titers at ≥ 4 After Each Vaccination
Hide Description Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time Frame 30 days post-vaccination
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 were evaluated in the per-protocol population.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description:
Participants aged 2 to less than 4 years who received 2 doses of vaccine
Participants aged 4 to less than 6 years who received 2 doses of vaccine
Participants aged 6 to less than 11 years who received a single dose of vaccine
Overall Number of Participants Analyzed 82 89 108
Measure Type: Number
Unit of Measure: Percentage of Participants
Serogroup A Post-dose 1 ≥ 4 [n = 82, 89, 107] 73 58 79
Serogroup A Post-dose 2 ≥ 4 [n = 81, 89, 0] 94 79 NA [1] 
Serogroup C Post-dose 1 ≥ 4 [n = 82, 89, 108] 78 63 69
Serogroup C Post-dose 2 ≥ 4 [n = 82, 89, 0] 95 91 NA [1] 
Serogroup Y Post-dose 1 ≥ 4 [n = 82, 89, 108] 77 83 83
Serogroup Y Post-dose 2 ≥ 4 [n = 82, 89, 0] 100 98 NA [1] 
Serogroup W-135 Post-dose 1 ≥ 4 [n = 82, 89, 108] 83 89 96
Serogroup W-135 Post-dose 2 ≥ 4 [n = 82, 89, 0] 99 100 NA [1] 
[1]
Dose 2 vaccination was not administered to the Menactra Group 3
3.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Meningococcal Antibodies After Each Menactra® Vaccination.
Hide Description Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by serum bactericidal assay using human complement (SBA-HC)
Time Frame 30 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers (GMTs) of Serum Bactericidal Assay Human Complement (SBA-HC) for the vaccine Serogroups were analyzed in the per-protocol population.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description:
Participants aged 2 to less than 4 years who received 2 doses of vaccine
Participants aged 4 to less than 6 years who received 2 doses of vaccine
Participants aged 6 to less than 11 years who received a single dose of vaccine
Overall Number of Participants Analyzed 82 89 108
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Serogroup A Post-dose 1 [n = 82, 89, 107]
9.97
(7.37 to 13.5)
5.59
(4.35 to 7.18)
12.7
(9.53 to 16.8)
Serogroup A Post-dose 2 [n = 81, 89, 0]
24.3
(17.4 to 33.9)
13.6
(9.77 to 18.9)
NA [1] 
(NA to NA)
Serogroup C Post-dose 1 [n = 82, 89, 108]
13.4
(9.76 to 18.4)
8.99
(6.41 to 12.6)
18.5
(12.1 to 28.4)
Serogroup C Post-dose 2 [n = 82, 89, 0]
92.8
(65.5 to 132)
46.1
(32.7 to 65.2)
NA [1] 
(NA to NA)
Serogroup Y Post-dose 1 [n = 82, 89, 108]
8.42
(6.51 to 10.9)
9.13
(7.27 to 11.5)
14.2
(10.8 to 18.6)
Serogroup Y Post-dose 2 [n = 82, 89, 0]
78.4
(62.4 to 98.6)
42.0
(32.1 to 55.0)
NA [1] 
(NA to NA)
Serogroup W-135 Post-dose 1 [n = 82, 89, 108]
12.4
(9.33 to 16.5)
15.5
(11.9 to 20.2)
24.1
(19.1 to 30.5)
Serogroup W-135 Post-dose 2 [n = 82, 89, 0]
57.8
(44.2 to 75.7)
50.3
(37.9 to 66.8)
NA [1] 
(NA to NA)
[1]
Dose 2 vaccination was not administered to the Menactra Group 3.
4.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 1 Vaccination
Hide Description Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time Frame 7 days post-vaccination 1
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description:
Participants aged 2 to less than 4 years who received 2 doses of vaccine
Participants aged 4 to less than 6 years who received 2 doses of vaccine
Participants aged 6 to less than 11 years who received a single dose of vaccine
Overall Number of Participants Analyzed 111 111 111
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction Post Dose 1 67 60 67
Any Pain 53 53 58
Grade 3 Pain (Incapacitating) 1 0 2
Any Erythema 47 27 32
Grade 3 Erythema (≥ 5 cm) 5 4 8
Any Swelling 23 18 23
Grade 3 Swelling (≥ 5 cm) 4 3 5
Any Solicited Systemic Reaction Post Dose 1 52 43 38
Any Fever 7 4 1
Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) 1 1 0
Any Headache 7 15 23
Grade 3 Headache (Prevents daily activities) 0 0 0
Any Vomiting 6 4 2
Grade 3 Vomiting (≥ 3 episodes per 24 hours) 0 1 0
Any Drowsiness 21 16 14
Grade 3 Drowsiness (Disabling) 1 4 0
Any Anorexia 20 10 7
Grade 3 Anorexia (Skips ≥ 3 meals) 0 0 0
Any Irritability 35 20 11
Grade 3 Irritability (>3 hours duration) 2 4 2
Any Arthralgia 7 8 7
Grade 3 Arthralgia (Unwllling to move due to pain) 0 0 1
Any Diarrhea 17 8 3
Grade 3 Diarrhea (≥ 5 episodes per 24 hours) 2 0 0
5.Secondary Outcome
Title Percentage of Participants Reporting Solicited Injection Site and Solicited Systemic Reactions After Dose 2 Vaccination
Hide Description Solicited injection site reactions: Erythema, Swelling, Pain. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia.
Time Frame 7 days post-vaccination 2
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated participants, intent-to-treat population.
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description:
Participants aged 2 to less than 4 years who received 2 doses of vaccine
Participants aged 4 to less than 6 years who received 2 doses of vaccine
Participants aged 6 to less than 11 years who received a single dose of vaccine
Overall Number of Participants Analyzed 111 111 0
Measure Type: Number
Unit of Measure: Percentage of Participants
Any Solicited Injection Site Reaction Post Dose 2 60 64
Any Pain 48 52
Grade 3 Pain (Incapacitating) 0 1
Any Erythema 37 36
Grade 3 Erythema (≥ 5 cm) 8 4
Any Swelling 20 15
Grade 3 Swelling (≥ 5 cm) 3 2
Any Solicited Systemic Reaction Post Dose 2 53 49
Any Fever 5 13
Grade 3 Fever (> 39.0 ºC or > 102.2 ºF) 0 3
Any Headache 6 14
Grade 3 Headache (Prevents daily activities) 0 1
Any Vomiting 5 7
Grade 3 Vomiting (≥ 3 episodes per 24 hours) 1 2
Any Drowsiness 19 18
Grade 3 Drowsiness (Disabling) 1 2
Any Anorexia 21 17
Grade 3 Anorexia (Skips ≥ 3 meals) 1 1
Any Irritability 31 23
Grade 3 Irritability (>3 hours duration) 5 3
Any Arthralgia 8 7
Grade 3 Arthralgia (Unwllling to move due to pain) 0 0
Any Diarrhea 15 7
Grade 3 Diarrhea (≥ 5 episodes per 24 hours) 0 0
Time Frame Adverse event data were collected from the day of vaccination (Day 0) up to 6 months post-dose 2 vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Hide Arm/Group Description Participants aged 2 to less than 4 years who received 2 doses of vaccine Participants aged 4 to less than 6 years who received 2 doses of vaccine Participants aged 6 to less than 11 years who received a single dose of vaccine
All-Cause Mortality
Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/111 (3.60%)      3/111 (2.70%)      0/111 (0.00%)    
Gastrointestinal disorders       
Enteritis * 1  0/111 (0.00%)  0 1/111 (0.90%)  1 0/111 (0.00%)  0
Infections and infestations       
Periorbital cellulitis * 1  0/111 (0.00%)  0 1/111 (0.90%)  1 0/111 (0.00%)  0
Pharyngitis * 1  0/111 (0.00%)  0 1/111 (0.90%)  1 0/111 (0.00%)  0
Urinary tract infection * 1  1/111 (0.90%)  1 0/111 (0.00%)  0 0/111 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration * 1  2/111 (1.80%)  2 0/111 (0.00%)  0 0/111 (0.00%)  0
Psychiatric disorders       
Breath holding * 1  1/111 (0.90%)  1 0/111 (0.00%)  0 0/111 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Bronchial hyperreactivity * 1  1/111 (0.90%)  1 0/111 (0.00%)  0 0/111 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Menactra® Group 1 Menactra® Group 2 Menactra® Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   58/111 (52.25%)      57/111 (51.35%)      64/111 (57.66%)    
Gastrointestinal disorders       
Diarrhea  1  19/109 (17.43%)  19 9/108 (8.33%)  9 3/111 (2.70%)  3
Vomiting  1  6/109 (5.50%)  6 7/103 (6.80%)  7 2/111 (1.80%)  2
General disorders       
Injection site erythma  1  51/109 (46.79%)  51 37/103 (35.92%)  37 35/111 (31.53%)  35
Fever  1  8/109 (7.34%)  8 13/103 (12.62%)  13 1/111 (0.90%)  1
Irritability  1  38/109 (34.86%)  38 24/103 (23.30%)  24 12/111 (10.81%)  12
Injection site pain * 1  58/109 (53.21%)  58 57/108 (52.78%)  57 64/111 (57.66%)  64
Pyrexia * 1  14/111 (12.61%)  14 8/111 (7.21%)  8 3/111 (2.70%)  3
Injection site swelling  1  25/109 (22.94%)  25 19/108 (17.59%)  19 25/111 (22.52%)  25
Injection site induration * 1  7/111 (6.31%)  7 5/111 (4.50%)  5 2/111 (1.80%)  2
Infections and infestations       
Nasopharyngitis * 1  6/111 (5.41%)  7 4/111 (3.60%)  4 2/111 (1.80%)  2
Otitis media * 1  6/111 (5.41%)  6 1/111 (0.90%)  1 0/111 (0.00%)  0
Upper respiratory tract infection * 1  6/111 (5.41%)  6 4/111 (3.60%)  4 0/111 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  8/109 (7.34%)  8 9/108 (8.33%)  9 8/111 (7.21%)  8
Nervous system disorders       
Drowsiness  1  23/109 (21.10%)  23 18/103 (17.48%)  18 16/111 (14.41%)  16
Headache  1  8/109 (7.34%)  8 16/108 (14.81%)  16 25/111 (22.52%)  25
Psychiatric disorders       
Anorexia  1  22/109 (20.18%)  22 17/103 (16.50%)  17 8/111 (7.21%)  8
Respiratory, thoracic and mediastinal disorders       
Cough * 1  18/111 (16.22%)  25 15/111 (13.51%)  16 1/111 (0.90%)  1
Rhinorrhea * 1  10/111 (9.01%)  12 4/111 (3.60%)  4 0/111 (0.00%)  0
Nasal congestion * 1  5/111 (4.50%)  5 9/111 (8.11%)  9 2/111 (1.80%)  2
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
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: NCT00700635     History of Changes
Other Study ID Numbers: MTA61
First Submitted: May 7, 2008
First Posted: June 19, 2008
Results First Submitted: December 11, 2010
Results First Posted: December 23, 2010
Last Update Posted: April 14, 2016