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Trial record 1 of 1 for:    MTA17
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Study of Reduced Dose of Menomune® in Children Who Previously Received Meningococcal Diphtheria Toxoid Conjugate Vaccine

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ClinicalTrials.gov Identifier: NCT00772070
Recruitment Status : Completed
First Posted : October 15, 2008
Results First Posted : May 14, 2009
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
Meningococcemia
Neisseria Meningitidis
Intervention Biological: A/C/Y/W-135, Meningococcal Polysaccharide Vaccine (Menomune®)
Enrollment 173
Recruitment Details Study participants were enrolled from 10 march through 13 June 2003 in 8 US clinic sites
Pre-assignment Details A total of 173 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Previously Received TetraMenD Meningococcal Vaccine-naive
Hide Arm/Group Description Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02. Participants have never received a Meningococcal vaccine in the past.
Period Title: Overall Study
Started 102 71
Completed 100 [1] 61
Not Completed 2 10
Reason Not Completed
Lost to Follow-up             0             8
Withdrawal by Subject             0             2
Vaccination error-wrong dose/expired lot             2             0
[1]
Two participants had vaccination errors, they were removed from analysis.
Arm/Group Title Previously Received TetraMenD Meningococcal Vaccine-naive Total
Hide Arm/Group Description Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02. Participants have never received a Meningococcal vaccine in the past. Total of all reporting groups
Overall Number of Baseline Participants 100 71 171
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 71 participants 171 participants
<=18 years
100
 100.0%
71
 100.0%
171.0
Between 18 and 65 years
0
   0.0%
0
   0.0%
0.0
>=65 years
0
   0.0%
0
   0.0%
0.0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 71 participants 171 participants
4.5  (0.52) 3.8  (0.87) 4.2  (0.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 71 participants 171 participants
Female
42
  42.0%
44
  62.0%
86.0
Male
58
  58.0%
27
  38.0%
85.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 100 participants 71 participants 171 participants
100 71 171
1.Primary Outcome
Title Geometric Mean Titers (GMT) of Serum Bactericidal Activity for Each Vaccine Serogroups Before and Post-vaccination.
Hide Description [Not Specified]
Time Frame Day 0 and Days 8 and 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were determined in the per-protocol population.
Arm/Group Title Previously Received TetraMenD Meningococcal Vaccine-naive
Hide Arm/Group Description:
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
Participants have never received a Meningococcal vaccine in the past.
Overall Number of Participants Analyzed 100 61
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal Serogroup A (Day 0)
316.1
(182.6 to 547.2)
126.5
(67.3 to 237.9)
Meningococcal Serogroup A (Day 8)
11411.9
(9196.5 to 14161.1)
6720.1
(5205.0 to 8676.2)
Meningococcal Serogroup A (Day 28)
5620.6
(4321.2 to 7310.8)
2603.3
(1767.0 to 3835.3)
Meningococcal Serogroup C (Day 0)
68.4
(41.2 to 113.6)
21.2
(11.6 to 38.9)
Meningococcal Serogroup C (Day 8)
8700.9
(6185.5 to 12239.1)
2447.5
(1651.9 to 3626.3)
Meningococcal Serogroup C (Day 28)
7261.6
(5213.5 to 10114.4)
300.4
(128.8 to 700.4)
Meningococcal Serogroup Y (Day 0)
411.5
(286.9 to 590.1)
241.8
(138.3 to 422.9)
Meningococcal Serogroup Y (Day 8)
7261.6
(5696.2 to 9257.2)
3859.7
(2751.1 to 5414.9)
Meningococcal Serogroup Y (Day 28)
3798.7
(2735.7 to 5274.8)
1410.0
(939.9 to 2115.3)
Meningococcal Serogroup W-135 (Day 0)
92.5
(57.9 to 147.8)
17.5
(10.8 to 28.2)
Meningococcal Serogroup W-135 (Day 8)
11761.1
(8556.4 to 16166.0)
5194.8
(3849.3 to 7010.5)
Meningococcal Serogroup W-135 (Day 28)
6245.9
(4231.8 to 9218.5)
2103.3
(1303.7 to 3393.3)
2.Other Pre-specified Outcome
Title Percentage of Participants With at Least a 4-fold Rise in Serum Bactericidal Activity to Each Vaccine Meningococcal Serogroups.
Hide Description [Not Specified]
Time Frame Baseline to Day 8 and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Fold rise analysis was assessed in per-protocol population with valid serology data.
Arm/Group Title Previously Received TetraMenD Meningococcal Vaccine-naive
Hide Arm/Group Description:
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
Participants have never received a Meningococcal vaccine in the past.
Overall Number of Participants Analyzed 46 35
Measure Type: Number
Unit of Measure: Percentage of participants
Meningococcal Serogroup A (Day 8) 93 89
Meningococcal Serogroup C (Day 8) 91 89
Meningococcal Serogroup Y (Day 8) 96 74
Meningococcal Serogroup W-135 (Day 8) 98 100
Meningococcal Serogroup A (Day 28) 72 85
Meningococcal Serogroup C (Day 28) 93 54
Meningococcal Serogroup Y (Day 28) 78 65
Meningococcal Serogroup W-135 (Day 28) 93 100
3.Other Pre-specified Outcome
Title Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-vaccination.
Hide Description [Not Specified]
Time Frame Day 0 to 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis was on all enrolled and vaccinated subjects with available reaction data, intent-to-treat population.
Arm/Group Title Previously Received TetraMenD Meningococcal Vaccine-naive
Hide Arm/Group Description:
Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02.
Participants have never received a Meningococcal vaccine in the past.
Overall Number of Participants Analyzed 100 69
Measure Type: Number
Unit of Measure: Percentage of participants
Any Solicited Local Reaction (Days 0-7) 46 45
Any Grade 3 Solicited Local Reaction (Days 0-7) 0 0
Any Redness 23 20
Grade 3 Redness (>2 inch) 0 0
Any Swelling 11 15
Grade 3 Swelling (>2 inch) 0 0
Any Induration 14 13
Grade 3 Induration (>2 inch) 0 0
Any Pain 34 33
Grade 3 Pain (Disabling, unable to move arm) 0 0
Any Solicited Systemic Reaction (Days 0-7) 38 42
Any Grade 3 Solicited Systemic Reaction (Days 0-7) 3 4
Any Fever 10 3
Grade 3 Fever (≥ 40.0°C) 0 0
Any Fussiness 22 30
Grade 3 Fussiness (Irritability for > 3 hours) 1 1
Any Drowsiness 17 12
Grd 3 Drowsiness: not interested in usual activity 1 1
Any Anorexia 8 13
Grade 3 Anorexia (Skipped ≥ 3 meals) 1 1
Any Vomiting 5 0
Grade 3 Vomiting (≥ 3 episodes) 2 0
Any Diarrhea 6 9
Grade 3 Diarrhea (≥ 5 episodes) 0 0
Time Frame Adverse events data were collected from the day of vaccination to 28 days post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Previously Received TetraMenD Meningococcal Vaccine-naive
Hide Arm/Group Description Participants previously received one dose of a Meningococcal vaccine, TetraMenD in Study 603-02. Participants have never received a Meningococcal vaccine in the past.
All-Cause Mortality
Previously Received TetraMenD Meningococcal Vaccine-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Previously Received TetraMenD Meningococcal Vaccine-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/71 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Previously Received TetraMenD Meningococcal Vaccine-naive
Affected / at Risk (%) Affected / at Risk (%)
Total   34/100 (34.00%)   33/71 (46.48%) 
Gastrointestinal disorders     
Vomiting NOS  1  5/100 (5.00%)  0/69 (0.00%) 
Diarrhoea  1  6/100 (6.00%)  9/69 (13.04%) 
General disorders     
Injection site erythema  1  23/100 (23.00%)  20/69 (28.99%) 
Injection site swelling  1  11/100 (11.00%)  15/69 (21.74%) 
Injection site Induration  1  14/100 (14.00%)  13/69 (18.84%) 
Injection site pain  1  34/100 (34.00%)  33/69 (47.83%) 
Pyrexia  1  10/100 (10.00%)  3/69 (4.35%) 
Infections and infestations     
Nasopharyngitis * 1  3/100 (3.00%)  4/71 (5.63%) 
Metabolism and nutrition disorders     
Anorexia  1  8/100 (8.00%)  13/69 (18.84%) 
Nervous system disorders     
Somnolence  1  17/100 (17.00%)  12/69 (17.39%) 
Psychiatric disorders     
Irritability  1  22/100 (22.00%)  30/69 (43.48%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  9/100 (9.00%)  3/71 (4.23%) 
Nasal congestion * 1  6/100 (6.00%)  2/71 (2.82%) 
Rhinorrhoea * 1  5/100 (5.00%)  1/71 (1.41%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
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: NCT00772070     History of Changes
Other Study ID Numbers: MTA17
First Submitted: October 13, 2008
First Posted: October 15, 2008
Results First Submitted: March 26, 2009
Results First Posted: May 14, 2009
Last Update Posted: February 14, 2014