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Safety and Immunogenicity Study of a Live Francisella Tularensis Vaccine

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: NCT00584844
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Tularemia
Intervention Biological: Live F tularensis Vaccine
Enrollment 484
Recruitment Details Enrollment at the Special Immunizations Clinic at USAMRIID is expected to last 5 years and include up to 1,000 subjects who were at risk of occupational exposure to F tularensis.
Pre-assignment Details  
Arm/Group Title F Tularensis Vaccine (0.0025 mL)
Hide Arm/Group Description

Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.

Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).

Period Title: Overall Study
Started 484
Completed 405
Not Completed 79
Reason Not Completed
Withdrawal by Subject             59
Screen Failure             20
Arm/Group Title F Tularensis Vaccine (0.0025 mL)
Hide Arm/Group Description

Subjects receive a small amount of F tularensis vaccine (0.0025mL) placed on a cleansed site on the skin on the volar surface of the forearm. A bifurcated needle was used to make 15 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine.

Live F tularensis Vaccine: Subjects will receive one drop of reconstituted F tularensis vaccine (approximately 0.0025 ml), applied with a bifurcated needle to the volar surface of the forearm, and the skin will be pricked 15 times over the prepared area. A booster dose will be given at the same dose volume and route of administration if the titer (days 56-84) is inadequate (< 1:20).

Overall Number of Baseline Participants 405
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
<20 years
2
   0.5%
20-29 years
108
  26.7%
30-39 years
126
  31.1%
40-49 years
106
  26.2%
50-59 years
54
  13.3%
60-69 years
9
   2.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
Female
145
  35.8%
Male
260
  64.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
Hispanic or Latino
23
   5.7%
Not Hispanic or Latino
382
  94.3%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 405 participants
American Indian or Alaska Native
2
   0.5%
Asian
13
   3.2%
Native Hawaiian or Other Pacific Islander
2
   0.5%
Black or African American
20
   4.9%
White
357
  88.1%
More than one race
11
   2.7%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 405 participants
405
1.Primary Outcome
Title Safety: Adverse Event Category Rates for All Vaccinations
Hide Description AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule.
Time Frame AEs/SAEs recorded through duration of study; immunogenicity via MA on days 0, 28-35, 56-84, and at 1 year
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Males Females
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All males in study
All females in study
Overall Number of Participants Analyzed 294 168
Measure Type: Number
Unit of Measure: Adverse events
Any AE: Mild 264 162
Any AE: Moderate 53 48
Any AE: Severe 11 10
Local: Mild 248 153
Local: Moderate 7 13
Locale: Severe 0 1
Systemic: Mild 121 105
Systemic: Moderate 48 42
Systemic: Severe 11 9
Relationship: Unrelated 30 28
Relationship: Unlikely 33 29
Relationship: Possible 86 77
Relationship: Probable 62 41
Relationship: Definate 246 153
Outcome: Resolved 271 163
Outcome: Resolved with sequelae 4 1
Treatment required:None 260 160
Treatment required: Intervention required 75 75
Treatment required: Other 7 1
Treatment required: Hospitalization 6 6
2.Secondary Outcome
Title Immunogenicity: Protocol Compliant Post-primary Titer Rates
Hide Description Percentage of subjects with less than or greater than titers (> or < 1:20) for compliant post-primary titers.
Time Frame 12 months
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Hide Analysis Population Description
As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 454 were compliant and analyzed.
Arm/Group Title Percent of Subjects
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Percentage of subjects in specific category
Overall Number of Participants Analyzed 454
Measure Type: Number
Unit of Measure: Percentage of subjects
Days 28-35: All subjects <1.20 4.1
Days 28-35: All subjects >1.20 95.9
Days 56-84: All subjects <1.20 73.3
Days 56-84: All subjects >1:20 26.7
Month 12: All subjects <1:20 3.6
Month 12: All subjects >1:20 96.4
Overall: <1:20 2.6
Overall: >1:20 97.4
3.Secondary Outcome
Title Immunogenicity: Protocol-compliant Post-boost 1 Titer Rates
Hide Description Percentage of subjects with less than or greater than titers (> or < 1:20) who received post-boost 1
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 19 were compliant and analyzed.
Arm/Group Title Percent of Subjects
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Percentage of subjects in specific category
Overall Number of Participants Analyzed 19
Measure Type: Number
Unit of Measure: Percentage of subjects
Days 28-35: <1:20 22.2
Days 28-35: >1:20 77.8
Days 56-84: <1:20 100.0
Days 56-84: >1:20 0
Month 12: <1:20 43.8
Month 12: >1:20 56.3
Overall: <1:20 26.3
Overall: >1:20 73.7
4.Secondary Outcome
Title Immunogenicity: Protocol-compliant Post-boost 2 Titer
Hide Description

Percentage of subjects with less than or greater than titers who received post-boost 2.

Responder = > 1:20 Non-responder = < 1:20

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
As stated in the protocol, only titers taken in compliance with the prescribed schedule were used in the statistical analysis. 18 were compliant and analyzed.
Arm/Group Title Percent of Subjects
Hide Arm/Group Description:
Percentage of subjects in specific category
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Percentage of subjects
Days 28-35: Non-Responder 5.6
Days 28-35:Responder 94.4
Days 56-84: Non-Responder 25.0
Days 56-84: Responder 75.0
Month 12: Non-Responder 6.3
Month 12: Responder 93.8
Overall: Non-Responder 5.3
Overall: Responder 94.7
Time Frame 12 months
Adverse Event Reporting Description AE analysis was conducted for all intent-to-treat subjects regardless of compliance with titer schedule. A single AE greater than 1 day duration that changed in severity was tabulated as one AE with only the highest severity coding. AE's were assessed on Days 1, 2, 7, 12-16, 28-35, 56-84 and 12 months.
 
Arm/Group Title Mild Moderate Severe
Hide Arm/Group Description Mild Moderate Severe
All-Cause Mortality
Mild Moderate Severe
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Mild Moderate Severe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/462 (0.00%)      10/462 (2.16%)      11/462 (2.38%)    
Cardiac disorders       
Myocardial infarction  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Ear and labyrinth disorders       
Eustachian tube dysfunction  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Hepatobiliary disorders       
Cholecystitis acute  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Cholelithiasis  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Infections and infestations       
Malaria  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Pilonidal cyst  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Injury, poisoning and procedural complications       
Burns second degree  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Femur fracture  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Foot fracture  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Ligament rupture  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Meniscus lesion  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Exostosis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Foot deformity  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Rotator cuff syndrome  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Spondylolysis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Nervous system disorders       
Neuropathy peripheral  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Psychiatric disorders       
Depression  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Renal and urinary disorders       
Nephrolithiasis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Reproductive system and breast disorders       
Menorrhagia  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Uterine haemorrhage  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Uterine prolapse  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Sleep apnoea syndrome  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.X
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mild Moderate Severe
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   426/462 (92.21%)      101/462 (21.86%)      21/462 (4.55%)    
Blood and lymphatic system disorders       
Lymph node pain  1  17/462 (3.68%)  17 1/462 (0.22%)  1 0/462 (0.00%)  0
Lymphadenopathy  1  79/462 (17.10%)  82 2/462 (0.43%)  2 0/462 (0.00%)  0
Cardiac disorders       
Myocardial infarction  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Palpitations  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Ear and labyrinth disorders       
Ear congestion  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Ear pain  1  2/462 (0.43%)  2 3/462 (0.65%)  3 0/462 (0.00%)  0
Eustachian tube dysfunction  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Eye disorders       
Conjunctivitis  1  0/462 (0.00%)  0 2/462 (0.43%)  2 0/462 (0.00%)  0
Conjunctivitis allergic  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Eye discharge  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Eye pruritus  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Ocular hyperaemia  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Photophobia  1  2/462 (0.43%)  2 2/462 (0.43%)  2 0/462 (0.00%)  0
Gastrointestinal disorders       
Abdominal discomfort  1  2/462 (0.43%)  2 1/462 (0.22%)  1 0/462 (0.00%)  0
Abdominal pain  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Abdominal pain lower  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Abdominal pain upper  1  3/462 (0.65%)  3 1/462 (0.22%)  1 0/462 (0.00%)  0
Aphthous stomatitis  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Constipation  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Diarrhoea  1  10/462 (2.16%)  10 3/462 (0.65%)  3 1/462 (0.22%)  1
Dry mouth  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Dyspepsia  1  1/462 (0.22%)  1 1/462 (0.22%)  1 0/462 (0.00%)  0
Gingival pain  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Nausea  1  18/462 (3.90%)  18 8/462 (1.73%)  8 2/462 (0.43%)  2
Toothache  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Vomiting  1  1/462 (0.22%)  1 1/462 (0.22%)  1 1/462 (0.22%)  1
General disorders       
Axillary pain  1  79/462 (17.10%)  79 6/462 (1.30%)  6 0/462 (0.00%)  0
Chest discomfort  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Chills  1  6/462 (1.30%)  7 5/462 (1.08%)  5 0/462 (0.00%)  0
Fatigue  1  36/462 (7.79%)  36 11/462 (2.38%)  11 2/462 (0.43%)  2
Feeling hot  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Influenza like illness  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Injection site discharge  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site erythema  1  355/462 (76.84%)  370 8/462 (1.73%)  8 1/462 (0.22%)  1
Injection site exfoliation  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site induration  1  104/462 (22.51%)  104 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site oedema  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site pain  1  79/462 (17.10%)  79 2/462 (0.43%)  2 0/462 (0.00%)  0
Injection site paraesthesia  1  3/462 (0.65%)  3 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site pruritus  1  111/462 (24.03%)  111 1/462 (0.22%)  1 0/462 (0.00%)  0
Injection site rash  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site vesicles  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Malaise  1  40/462 (8.66%)  40 9/462 (1.95%)  9 1/462 (0.22%)  1
Non-cardiac chest pain  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Oedema peripheral  1  1/462 (0.22%)  1 1/462 (0.22%)  1 0/462 (0.00%)  0
Pain  1  14/462 (3.03%)  14 3/462 (0.65%)  3 1/462 (0.22%)  1
Pyrexia  1  12/462 (2.60%)  12 8/462 (1.73%)  8 1/462 (0.22%)  1
Vaccination site pain  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis acute  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Cholelithiasis  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Infections and infestations       
Bronchitis  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Conjunctivitis infective  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Eye infection  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Folliculitis  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Gastroenteritis viral  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Hordeolum  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Injection site pustule  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Lower respiratory tract infection  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Lymphangitis  1  4/462 (0.87%)  4 0/462 (0.00%)  0 0/462 (0.00%)  0
Malaria  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Oral herpes  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Pharyngitis streptococcal  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Pilonidal cyst  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Respiratory tract infection  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Rhinitis  1  6/462 (1.30%)  6 1/462 (0.22%)  1 0/462 (0.00%)  0
Sinusitis  1  2/462 (0.43%)  2 2/462 (0.43%)  2 0/462 (0.00%)  0
Upper respiratory tract infection  1  1/462 (0.22%)  1 2/462 (0.43%)  2 0/462 (0.00%)  0
Urinary tract infection  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Vaginal infection  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Viral upper respiratory tract infection  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Injury, poisoning and procedural complications       
Animal bite  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Animal scratch  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Ankle fracture  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Arthropod bite  1  3/462 (0.65%)  3 0/462 (0.00%)  0 0/462 (0.00%)  0
Burns second degree  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Contusion  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Epicondylitis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Eye injury  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Femur fracture  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Foot fracture  1  0/462 (0.00%)  0 0/462 (0.00%)  0 2/462 (0.43%)  2
Joint sprain  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Ligament rupture  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Limb crushing injury  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Limb injury  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Meniscus lesion  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Muscle strain  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Skin laceration  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Vaccination complication  1  6/462 (1.30%)  6 0/462 (0.00%)  0 0/462 (0.00%)  0
Investigations       
Lymph node palpable  1  19/462 (4.11%)  19 1/462 (0.22%)  1 0/462 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  2/462 (0.43%)  2 0/462 (0.00%)  0 1/462 (0.22%)  1
Gout  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  30/462 (6.49%)  34 4/462 (0.87%)  4 0/462 (0.00%)  0
Back pain  1  3/462 (0.65%)  3 2/462 (0.43%)  2 1/462 (0.22%)  1
Exostosis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Foot deformity  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Groin pain  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Muscle spasms  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Muscle tightness  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Musculoskeletal chest pain  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Musculoskeletal pain  1  17/462 (3.68%)  19 3/462 (0.65%)  4 0/462 (0.00%)  0
Musculoskeletal stiffness  1  6/462 (1.30%)  6 1/462 (0.22%)  1 0/462 (0.00%)  0
Myalgia  1  23/462 (4.98%)  23 5/462 (1.08%)  5 0/462 (0.00%)  0
Neck pain  1  6/462 (1.30%)  6 0/462 (0.00%)  0 1/462 (0.22%)  1
Nodule on extremity  1  10/462 (2.16%)  10 1/462 (0.22%)  1 0/462 (0.00%)  0
Pain in extremity  1  42/462 (9.09%)  43 5/462 (1.08%)  5 0/462 (0.00%)  0
Pain in jaw  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Rotator cuff syndrome  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Spondylolysis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Nervous system disorders       
Disturbance in attention  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Dizziness  1  7/462 (1.52%)  7 2/462 (0.43%)  2 1/462 (0.22%)  1
Headache  1  86/462 (18.61%)  86 23/462 (4.98%)  23 3/462 (0.65%)  3
Lethargy  1  1/462 (0.22%)  1 0/462 (0.00%)  0 1/462 (0.22%)  1
Migraine  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Neuropathy peripheral  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Paraesthesia  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Sinus headache  1  2/462 (0.43%)  2 2/462 (0.43%)  2 0/462 (0.00%)  0
Tension headache  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Psychiatric disorders       
Depression  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Insomnia  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Panic attack  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Renal and urinary disorders       
Bladder discomfort  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Dysuria  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Nephrolithiasis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Reproductive system and breast disorders       
Dysmenorrhoea  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Menorrhagia  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Prostatitis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Uterine haemorrhage  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Uterine prolapse  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  23/462 (4.98%)  23 3/462 (0.65%)  3 0/462 (0.00%)  0
Dry throat  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Dysphonia  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Nasal congestion  1  27/462 (5.84%)  27 5/462 (1.08%)  5 0/462 (0.00%)  0
Oropharyngeal pain  1  34/462 (7.36%)  34 6/462 (1.30%)  6 0/462 (0.00%)  0
Postnasal drip  1  1/462 (0.22%)  1 1/462 (0.22%)  1 0/462 (0.00%)  0
Productive cough  1  3/462 (0.65%)  3 2/462 (0.43%)  2 0/462 (0.00%)  0
Respiratory tract congestion  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Rhinorrhoea  1  6/462 (1.30%)  6 1/462 (0.22%)  1 0/462 (0.00%)  0
Sinus congestion  1  13/462 (2.81%)  13 3/462 (0.65%)  3 0/462 (0.00%)  0
Sleep apnoea syndrome  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Sneezing  1  5/462 (1.08%)  5 2/462 (0.43%)  2 0/462 (0.00%)  0
Throat irritation  1  7/462 (1.52%)  7 0/462 (0.00%)  0 0/462 (0.00%)  0
Throat tightness  1  0/462 (0.00%)  0 0/462 (0.00%)  0 1/462 (0.22%)  1
Wheezing  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Skin and subcutaneous tissue disorders       
Dermatitis  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Dermatitis allergic  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Dermatitis contact  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Eczema  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Hyperhidrosis  1  2/462 (0.43%)  2 2/462 (0.43%)  2 0/462 (0.00%)  0
Night sweats  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Photosensitivity reaction  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Pruritus  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Pruritus generalised  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Rash  1  3/462 (0.65%)  3 0/462 (0.00%)  0 0/462 (0.00%)  0
Rash papular  1  2/462 (0.43%)  2 0/462 (0.00%)  0 0/462 (0.00%)  0
Rash pruritic  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Swelling face  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Surgical and medical procedures       
Sinus operation  1  3/462 (0.65%)  3 0/462 (0.00%)  0 0/462 (0.00%)  0
Vascular disorders       
Hypertension  1  1/462 (0.22%)  1 0/462 (0.00%)  0 0/462 (0.00%)  0
Phlebitis  1  0/462 (0.00%)  0 1/462 (0.22%)  1 0/462 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.X
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark Goldberg, MD
Organization: USAMRIID
Phone: 301-619-4562
EMail: mark.goldberg@amedd.mil
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00584844     History of Changes
Other Study ID Numbers: A-12775
FY03-24 ( Other Identifier: SIP )
First Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: December 28, 2016
Results First Posted: July 2, 2017
Last Update Posted: July 2, 2017