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Trial record 1 of 1 for:    MPT01
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Safety and Immunogenicity of Intradermal Versus Subcutaneous Doses of Menomune®

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ClinicalTrials.gov Identifier: NCT00850603
Recruitment Status : Completed
First Posted : February 25, 2009
Results First Posted : April 30, 2009
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: None (Open Label);   Primary Purpose: Prevention
Conditions Meningococcal Infections
Meningitis
Intervention Biological: Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined
Enrollment 170
Recruitment Details Study participants were enrolled from 15 through 16 October 2002 in 1 US site
Pre-assignment Details A total of 170 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title 0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Hide Arm/Group Description Participants received 0.5 mL Subcutaneous Menomune® Participants received 0.1 mL Subcutaneous Menomune® Participants received 0.05 mL Intradermal Menomune® Participants received 0.1 mL Intradermal Menomune® Participants received 0.15 mL Intradermal Menomune®
Period Title: Overall Study
Started 34 34 34 34 34
Completed 34 34 34 34 34
Not Completed 0 0 0 0 0
Arm/Group Title 0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune® Total
Hide Arm/Group Description Participants received 0.5 mL Subcutaneous Menomune® Participants received 0.1 mL Subcutaneous Menomune® Participants received 0.05 mL Intradermal Menomune® Participants received 0.1 mL Intradermal Menomune® Participants received 0.15 mL Intradermal Menomune® Total of all reporting groups
Overall Number of Baseline Participants 34 34 34 34 34 170
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 34 participants 34 participants 34 participants 170 participants
<=18 years
2
   5.9%
1
   2.9%
2
   5.9%
5
  14.7%
1
   2.9%
11
   6.5%
Between 18 and 65 years
32
  94.1%
33
  97.1%
32
  94.1%
29
  85.3%
33
  97.1%
159
  93.5%
>=65 years
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:  Years
Number Analyzed 34 participants 34 participants 34 participants 34 participants 34 participants 170 participants
25.8  (9.68) 24.3  (7.10) 24.4  (7.64) 24.5  (8.46) 28.9  (12.85) 25.6  (9.42)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 34 participants 34 participants 34 participants 34 participants 170 participants
Female
22
  64.7%
23
  67.6%
16
  47.1%
15
  44.1%
17
  50.0%
93
  54.7%
Male
12
  35.3%
11
  32.4%
18
  52.9%
19
  55.9%
17
  50.0%
77
  45.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants 34 participants 34 participants 34 participants 34 participants 170 participants
34 34 34 34 34 170
1.Primary Outcome
Title Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers
Hide Description Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination.
Time Frame Baseline to 28 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
4-Fold rise analysis was in the per-protocol population with valid serology data
Arm/Group Title 0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Hide Arm/Group Description:
Participants received 0.5 mL Subcutaneous Menomune®
Participants received 0.1 mL Subcutaneous Menomune®
Participants received 0.05 mL Intradermal Menomune®
Participants received 0.1 mL Intradermal Menomune®
Participants received 0.15 mL Intradermal Menomune®
Overall Number of Participants Analyzed 34 34 34 34 34
Measure Type: Number
Unit of Measure: Percentage of participants
Meningococcal serogroup A 85 61 61 76 84
Meningococcal serogroup C 79 58 67 70 88
Meningococcal serogroup Y 64 68 61 58 66
Meningococcal serogroup W-135 88 77 73 79 97
2.Primary Outcome
Title Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination.
Hide Description GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination.
Time Frame Baseline (Day 0) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric mean titers were determined in the per-protocol population.
Arm/Group Title 0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Hide Arm/Group Description:
Participants received 0.5 mL Subcutaneous Menomune®
Participants received 0.1 mL Subcutaneous Menomune®
Participants received 0.05 mL Intradermal Menomune®
Participants received 0.1 mL Intradermal Menomune®
Participants received 0.15 mL Intradermal Menomune®
Overall Number of Participants Analyzed 34 34 34 34 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Meningococcal serogroup A (Day 0)
462.4
(222.4 to 961.4)
320.4
(127.7 to 803.8)
267.0
(114.5 to 622.7)
381.6
(195.7 to 743.8)
261.6
(131.1 to 522.1)
Meningococcal serogroup A (Day 28)
5496.3
(3262.8 to 9258.7)
3662.7
(2392.4 to 5607.7)
1775.6
(1116.3 to 2824.5)
3079.0
(2298.4 to 4124.7)
4013.3
(2575.7 to 6253.4)
Meningococcal serogroup C (Day 0)
48.1
(20.1 to 115.0)
85.1
(34.6 to 209.7)
50.8
(20.7 to 124.4)
53.0
(21.6 to 129.7)
41.5
(18.8 to 91.4)
Meningococcal serogroup C (Day 28)
2989.0
(1475.1 to 6056.5)
1751.3
(934.0 to 3283.8)
1478.0
(647.4 to 3374.3)
1307.8
(661.8 to 2584.4)
2780.6
(1428.3 to 5413.2)
Meningococcal serogroup Y (Day 0)
301.3
(138.3 to 656.5)
166.8
(73.0 to 381.5)
164.7
(73.3 to 370.2)
216.4
(103.8 to 451.2)
189.0
(93.5 to 382.1)
Meningococcal serogroup Y (Day 28)
1883.0
(1185.2 to 2991.4)
2002.7
(1163.3 to 3447.9)
1390.3
(742.1 to 2604.8)
1603.6
(1111.6 to 2313.3)
1887.6
(1120.4 to 3180.3)
Meningococcal serogroup W-135 (Day 0)
32.7
(15.3 to 69.8)
37.7
(19.0 to 74.7)
47.7
(24.5 to 93.0)
34.1
(16.0 to 72.8)
19.4
(9.7 to 38.9)
Meningococcal serogroup W-135 (Day 28)
1374.1
(846.9 to 2229.4)
856.3
(465.9 to 1573.8)
1390.3
(805.1 to 2400.9)
1307.8
(881.6 to 1940.2)
2006.7
(1204.5 to 3343.0)
3.Secondary Outcome
Title Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination.
Hide Description Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune®
Time Frame Day 0 to 7 days post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Hide Arm/Group Description:
Participants received 0.5 mL Subcutaneous Menomune®
Participants received 0.1 mL Subcutaneous Menomune®
Participants received 0.05 mL Intradermal Menomune®
Participants received 0.1 mL Intradermal Menomune®
Participants received 0.15 mL Intradermal Menomune®
Overall Number of Participants Analyzed 34 34 34 34 34
Measure Type: Number
Unit of Measure: Participants
Any Local Reaction 8 5 9 10 18
Any Grade 3 Local Reaction 0 0 0 0 0
Any Redness 2 2 8 9 18
Grade 3 Redness ( ≥ 2 inchs) 0 0 0 0 0
Any Swelling 0 1 4 5 10
Grade 3 Swelling ( ≥ 2 inchs) 0 0 0 0 0
Any Tenderness 6 4 1 1 3
Grade 3 Tenderness (disabling) 0 0 0 0 0
Any Pain 1 0 0 1 0
Grade 3 Pain (disabling) 0 0 0 0 0
Any Systemic Reaction 4 9 7 4 3
Any Grade 3 Systemic Reaction 0 2 0 0 0
Any Fever 0 0 0 0 0
Grade 3 Fever (≥ 39.6 ºC) 0 0 0 0 0
Any Chills 1 2 0 1 0
Grade 3 Chills (disabling) 0 0 0 0 0
Any Headache 2 6 3 2 1
Grade 3 Headache (disabling) 0 1 0 0 0
Any Dizziness 1 0 1 0 0
Grade 3 Dizziness (disabling) 0 0 0 0 0
Any Malaise 0 2 1 1 1
Grade 3 Malaise (disabling) 0 0 0 0 0
Any Myalgia 0 1 2 0 0
Grade 3 Myalgia (disabling) 0 0 0 0 0
Any Nausea 0 3 0 1 1
Grade 3 Nausea (disabling) 0 0 0 0 0
Any Vomiting 0 1 0 0 0
Grade 3 Vomiting (≥3 episodes) 0 0 0 0 0
Any Diarrhea 0 2 0 0 0
Grade 3 Diarrhea (≥3 episodes) 0 1 0 0 0
Any Arthralgia 1 4 2 2 1
Grade 3 Arthralgia (disabling) 0 0 0 0 0
Any Injection site Rash 1 0 1 0 1
Time Frame Adverse events data were collected from the day of vaccination for 28 days post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Hide Arm/Group Description Participants received 0.5 mL Subcutaneous Menomune® Participants received 0.1 mL Subcutaneous Menomune® Participants received 0.05 mL Intradermal Menomune® Participants received 0.1 mL Intradermal Menomune® Participants received 0.15 mL Intradermal Menomune®
All-Cause Mortality
0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/34 (0.00%)      1/34 (2.94%)      0/34 (0.00%)      0/34 (0.00%)      0/34 (0.00%)    
Gastrointestinal disorders           
Abdominal pain NOS * 1  0/34 (0.00%)  0 1/34 (2.94%)  2 0/34 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 6.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.5 mL Subcutaneous Menomune® 0.1 mL Subcutaneous Menomune® 0.05 mL Intradermal Menomune® 0.1 mL Intradermal Menomune® 0.15 mL Intradermal Menomune®
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/34 (23.53%)      9/34 (26.47%)      9/34 (26.47%)      10/34 (29.41%)      18/34 (52.94%)    
Gastrointestinal disorders           
Nausea  1  0/34 (0.00%)  0 3/34 (8.82%)  3 0/34 (0.00%)  0 1/34 (2.94%)  1 1/34 (2.94%)  1
Diarrhoea  1  0/34 (0.00%)  0 2/34 (5.88%)  2 0/34 (0.00%)  0 0/34 (0.00%)  0 0/34 (0.00%)  0
General disorders           
Injection site redness  1  2/34 (5.88%)  2 2/34 (5.88%)  2 8/34 (23.53%)  8 9/34 (26.47%)  9 18/34 (52.94%)  18
Injection site swelling  1  0/34 (0.00%)  0 1/34 (2.94%)  1 4/34 (11.76%)  4 5/34 (14.71%)  5 10/34 (29.41%)  10
Injection site tenderness  1  6/34 (17.65%)  6 4/34 (11.76%)  4 1/34 (2.94%)  1 1/34 (2.94%)  1 3/34 (8.82%)  3
Malaise  1  0/34 (0.00%)  0 2/34 (5.88%)  2 1/34 (2.94%)  1 1/34 (2.94%)  1 1/34 (2.94%)  1
Musculoskeletal and connective tissue disorders           
Chills  1  1/34 (2.94%)  1 2/34 (5.88%)  2 0/34 (0.00%)  0 1/34 (2.94%)  1 0/34 (0.00%)  0
Myalgia  1  0/34 (0.00%)  0 1/34 (2.94%)  1 2/34 (5.88%)  2 0/34 (0.00%)  0 0/34 (0.00%)  0
Arthralgia  1  1/34 (2.94%)  1 4/34 (11.76%)  4 2/34 (5.88%)  2 2/34 (5.88%)  2 1/34 (2.94%)  1
Nervous system disorders           
Headache  1  2/34 (5.88%)  2 6/34 (17.65%)  6 3/34 (8.82%)  3 2/34 (5.88%)  2 1/34 (2.94%)  1
Indicates events were collected by 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: NCT00850603     History of Changes
Other Study ID Numbers: MPT01
First Submitted: February 24, 2009
First Posted: February 25, 2009
Results First Submitted: March 13, 2009
Results First Posted: April 30, 2009
Last Update Posted: April 14, 2016