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Trial record 63 of 75 for:    "Rabies" | "Immunologic Factors"

FMP2.1/AS02A: Rabies Vaccine Malaria-Experienced Adults in Bandiagara, Mali

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ClinicalTrials.gov Identifier: NCT00349713
Recruitment Status : Completed
First Posted : July 10, 2006
Results First Posted : July 24, 2017
Last Update Posted : July 24, 2017
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
University of Maryland, College Park
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Malaria
Plasmodium Falciparum Malaria
Interventions Biological: FMP2.1/AS02A
Biological: Rabies vaccine (RabAvert)
Enrollment 60
Recruitment Details 175 participants were screened; 115 were excluded; 60 subjects were randomized in a 2:1 ratio into 2 cohorts
Pre-assignment Details  
Arm/Group Title Cohort 1: FMP2.1 / AS02A Cohort 2: FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert)
Hide Arm/Group Description

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Period Title: Overall Study
Started 20 20 20
Completed 20 20 20
Not Completed 0 0 0
Arm/Group Title Cohort 1: 25ug FMP2.1 / AS02A Cohort 2: 50ug FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert) Total
Hide Arm/Group Description

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 60 participants
Female
4
  20.0%
4
  20.0%
3
  15.0%
11
  18.3%
Male
16
  80.0%
16
  80.0%
17
  85.0%
49
  81.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Mali Number Analyzed 20 participants 20 participants 20 participants 60 participants
20
 100.0%
20
 100.0%
20
 100.0%
60
 100.0%
1.Primary Outcome
Title Safety and Reactogenicity (SAEs and AEs)
Hide Description The primary objective was to evaluate the safety and reactogenicity of 2 dose levels of WRAIR's AMA1 malaria antigen (FMP2.1) adjuvanted in GlaxoSmithKline Biologicals' (GSK) AS02A compared to rabies vaccine in malaria-experienced Malian adults aged 18-55 years inclusive. Solicated AEs were recorded for the 7 day surveillance period after each vaccination. Unsolicited AEs were recorded for 30 days after each vaccination.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Summary of Adverse Events by Group and Immunization Group
Arm/Group Title Cohort 1: 25ug FMP2.1 / AS02A Cohort 2: 50ug FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert)
Hide Arm/Group Description:

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Overall Number of Participants Analyzed 20 20 20
Measure Type: Number
Unit of Measure: Number of events
Solicited: Injection Site Pain 45 53 22
Solicited: Injection Site Swelling 37 35 11
Solicited: Arm Motion Limitation 5 3 0
Solicited: Elevated Temperature 6 6 1
Solicited: Headache 7 17 9
Solicited: Chills 4 2 4
Solicited: Malaise 4 5 3
Solicited: Nausea 4 1 1
Solicited: Arthralgia 0 2 1
Solicited: Myalgia 3 6 3
Solicited: Erythema 0 0 0
Unsolicited: Cold 21 10 7
Unsolicited: Headaches 11 11 5
Unsolicited: Coughing 8 3 3
Unsolicited: Flu 6 3 3
Unsolicited: Wound 3 2 4
Unsolicited: Myalgia 2 2 4
Unsolicited: Scratch 1 2 3
Unsolicited: Diarrhea 1 2 3
Unsolicited: Pruritus 1 4 1
2.Secondary Outcome
Title Antibody Response to FMP2.1 Over Time
Hide Description Measurement of anti-AMA1 antibody titers over time
Time Frame 90 Days
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Hide Analysis Population Description
Anti-AMA1 Antibody titers on days, 0, 14, 30, 44, 60, 74, and 90
Arm/Group Title Cohort 1: 25ug FMP2.1 / AS02A Cohort 2: 50ug FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert)
Hide Arm/Group Description:

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: Antibody Titers
Day 0 53295.3  (76881) 56779.4  (53811.2) 59852  (101952.4)
Day 14 62963.8  (77633.3) 120677.4  (104675.9) 63697.6  (119009.9)
Day 30 68251.2  (87406.5) 101464.5  (99045.2) 51436.1  (95888.9)
Day 44 101478.2  (139781.1) 159449.2  (152111.2) 62498.3  (115667.3)
Day 60 103966.8  (117998.7) 187453.9  (162090.9) 77418.1  (147844.9)
Day 74 128323.7  (109759) 227692.0  (236420.5) 82794.3  (173534.6)
Day 90 87684.2  (99596.7) 162739.7  (182897.2) 52575.5  (99568.0)
3.Secondary Outcome
Title Anti-AMA1 Log Antibody Titers Over Time
Hide Description Summary of Anti-AMA1 Log Antibody titers on days 0, 14, 30, 44, 60, 74 and 90
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: 25ug FMP2.1 / AS02A Cohort 2: 50ug FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert)
Hide Arm/Group Description:

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Overall Number of Participants Analyzed 20 20 20
Mean (Standard Deviation)
Unit of Measure: log antibody titers
Day 0 4.3  (0.7) 44.4  (0.9) 4.2  (0.8)
Day 14 4.5  (0.6) 4.8  (0.6) 4.1  (0.8)
Day 30 4.5  (0.6) 4.7  (0.6) 4.1  (0.8)
Day 44 4.7  (0.5) 5.0  (0.5) 4.1  (0.8)
Day 60 4.8  (0.5) 5.1  (0.5) 4.2  (0.8)
Day 74 4.9  (0.4) 5.2  (0.4) 4.1  (0.8)
Day 90 4.8  (0.4) 5.0  (0.4) 4.0  (0.9)
4.Secondary Outcome
Title Geometric Mean Antibody Titers Over Time
Hide Description Measurement of geometric mean antibody titers on days 0, 14, 30, 44, 60, 74 and 90
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: 25ug FMP2.1 / AS02A Cohort 2: 50ug FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert)
Hide Arm/Group Description:

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Overall Number of Participants Analyzed 20 20 20
Geometric Mean (95% Confidence Interval)
Unit of Measure: Geometric Mean of Antibody Titers
Day 0
19161.2
(8569.5 to 42843.9)
23499.7
(9078.9 to 60825.6)
14354.8
(5859.8 to 35164.9)
Day 14
30795.3
(16398.1 to 57829.4)
69751.6
(37929.2 to 128272.7)
13856.7
(5568.2 to 34483.1)
Day 30
31804.9
(16571.8 to 61040.8)
55085.8
(29386.5 to 103260.1)
12690.7
(5296.6 to 30407.1)
Day 44
55246.5
(33102.4 to 92204.0)
100589.6
(61275.4 to 165127.7)
13941.2
(5719.8 to 33979.9)
Day 60
61438.6
(36763.7 to 102674.5)
119191.3
(71967.1 to 197403.6)
16030.5
(6502.6 to 39518.8)
Day 74
89856.7
(57817.9 to 139649.3)
150738.4
(97729.2 to 232500.5)
14064.5
(5534.1 to 35743.6)
Day 90
60967.1
(41140.3 to 90348.9)
102813.0
(65715.6 to 160852.4)
10425.1
(4079.6 to 26640.2)
5.Secondary Outcome
Title Subjects With 2- and 4-fold Increases in Anti-FMP2.1 Antibody Levels Over Time
Hide Description Proportion of Subjects with 2- and 4-fold increases in Anti-FMP2.1 Antibody levels on days 14, 30, 44, 60, 74 and 90
Time Frame 90 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1: 25ug FMP2.1 / AS02A Cohort 2: 50ug FMP2.1 / AS02A Cohorts 1 and 2: Rabies Vaccine (RabAvert)
Hide Arm/Group Description:

20 subject to receive 25ug of FMP2.1 vaccine in 0.25mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive 50ug of FMP2.1 vaccine in 0.5mL of GSK Biologicals' adjuvant AS02A

FMP2.1/AS02A: FMP2.1 in GSK Biologicals' AS02A

20 subjects to receive Rabies vaccine (RabAvert). 10 subjects from Cohort 1 and 10 subjects from Cohort 2

Rabies vaccine (RabAvert): RabAvert Rabies vaccine

Overall Number of Participants Analyzed 20 20 20
Measure Type: Number
Unit of Measure: number of participants with increase
Day 14 2-fold increase 5 9 0
Day 14 4-fold increase 1 5 0
Day 30 2-fold increase 2 4 0
Day 30 4-fold increase 2 4 0
Day 44 2-fold increase 3 6 0
Day 44 4-fold increase 3 6 0
Day 60 2-fold increase 6 7 0
Day 60 4-fold increase 6 7 0
Day 74 2-fold increase 9 11 0
Day 74 4-fold increase 9 11 0
Day 90 2-fold increase 6 7 0
Day 90 4-fold increase 6 7 0
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: 25 ug FMP2.1 / AS02 Cohort 2: 50 ug FMP2.1 / AS02A Cohort 3: Rabies Vaccine (RabAvert)
Hide Arm/Group Description 25 ug FMPs.1 / AS02 50 ug FMP2.1 / AS02A Rabies vaccine, All events reports instead of AE's per vaccination group 20 subjects (10 from Cohort 1 and 10 from Cohort 2)
All-Cause Mortality
Cohort 1: 25 ug FMP2.1 / AS02 Cohort 2: 50 ug FMP2.1 / AS02A Cohort 3: Rabies Vaccine (RabAvert)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: 25 ug FMP2.1 / AS02 Cohort 2: 50 ug FMP2.1 / AS02A Cohort 3: Rabies Vaccine (RabAvert)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: 25 ug FMP2.1 / AS02 Cohort 2: 50 ug FMP2.1 / AS02A Cohort 3: Rabies Vaccine (RabAvert)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      20/20 (100.00%)      20/20 (100.00%)    
Cardiac disorders       
Extrasystol * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Heart racing * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Palpitation * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Premature/ectopic heart beat * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Tachycardia at 100beats/min * 1  1/20 (5.00%)  1 3/20 (15.00%)  3 0/20 (0.00%)  0
Ear and labyrinth disorders       
Left otalgia * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Right otitis * 1  2/20 (10.00%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Ringing in the ears * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Eye disorders       
Chalazion * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 1/20 (5.00%)  1
Eye pain * 1  2/20 (10.00%)  2 1/20 (5.00%)  1 0/20 (0.00%)  0
Eye tearing and itching * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Keratitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Ocular affection * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Right eye pain * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Right eye pterygium * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Visual floaters * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders       
Abdominal pain * 1  2/20 (10.00%)  2 4/20 (20.00%)  4 1/20 (5.00%)  1
Bilious vomiting * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Blood streak in stool * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Dental cavity tooth #18 * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Diarrhea * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 3/20 (15.00%)  3
Dysentery * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Dyspepsia * 1  2/20 (10.00%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Epigastric pain * 1  2/20 (10.00%)  2 2/20 (10.00%)  2 0/20 (0.00%)  0
Eructation * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Gastritis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 2/20 (10.00%)  2
Gingivitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Heartburn * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Hypochondrium pain * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Left upper premolar tooth pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Liquid diarrhea * 1  1/20 (5.00%)  1 2/20 (10.00%)  2 0/20 (0.00%)  0
Nausea  1  5/20 (25.00%)  5 2/20 (10.00%)  2 0/20 (0.00%)  0
Pain in right hypochondium * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Pain of right hypochondrium * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Pain with shaking of the right hypochondrium * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Presence of blood in stools * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Right inguinal hernia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Toothache * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Vomiting  1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
General disorders       
Excessive sweating * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Facial sweating * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Fatigue * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Febrile at 37.5 C  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Febrile to 37.8 C  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Fever  1  6/20 (30.00%)  6 4/20 (20.00%)  4 0/20 (0.00%)  0
Flu like symptoms * 1  11/20 (55.00%)  11 8/20 (40.00%)  8 0/20 (0.00%)  0
Malaise  1  6/20 (30.00%)  6 7/20 (35.00%)  7 0/20 (0.00%)  0
Physical weakness * 1  2/20 (10.00%)  2 3/20 (15.00%)  3 0/20 (0.00%)  0
Subjective evening fever  1  2/20 (10.00%)  2 2/20 (10.00%)  2 0/20 (0.00%)  0
Sweats * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Swelling of right thumb * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Temperature = 37.5C  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Thumb inflammation * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Immune system disorders       
Allergic cold symptoms * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Allergic conjunctivitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Hives * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Infections and infestations       
Bacterial conjunctivitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Conjunctivitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 2/20 (10.00%)  2
Dental abscess tooth #21 * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Dermatomycosis of inguinal folds * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Epididymitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 1/20 (5.00%)  1
Conjunctivitis left eye * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Periodontitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pityriasis versicolor * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Purulent conjunctivitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Right eye conjunctivitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Super infected wounds on left leg * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Syndrome of tissue hyperfusion * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Syndrome typhic * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Typhoid syndrome * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Uncomplicated malaria episode * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Injury, poisoning and procedural complications       
Acute injection site pain  1  2/20 (10.00%)  2 3/20 (15.00%)  3 0/20 (0.00%)  0
Foreign body in eye causing tearing * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Induced injection site pain  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Injection site edema (grade 1)  1  4/20 (20.00%)  4 2/20 (10.00%)  2 0/20 (0.00%)  0
Injection site edema (grade 2  1  20/20 (100.00%)  20 9/20 (45.00%)  9 0/20 (0.00%)  0
Injection site edema (grade 3)  1  9/20 (45.00%)  9 20/20 (100.00%)  20 0/20 (0.00%)  0
Injection site pain (grade 1)  1  20/20 (100.00%)  20 20/20 (100.00%)  20 1/20 (5.00%)  1
Injection site pain (grade 2)  1  1/20 (5.00%)  1 3/20 (15.00%)  3 0/20 (0.00%)  0
Injection site pain with pulsatile sensation (grade 1)  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Injection site pain extending to left elbow (grade 1)  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Injection site pain extending to left shoulder (grade 1)  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Injection site pain with movement (grade 1)  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Injection site pruritus  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Injection site pulsation (grade 1)  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Injury * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 8/20 (40.00%)  8
Left food punture wound * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Left foot scratch * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Left foot wound on lateral, external aspect * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Needle stick injury * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pain at venipuncture site  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Post-traumatic pain of the right elbow and wrist * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Post-traumatic right foot pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Right ankle pain after dislocation since 2002 * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Right ankle traumatic wound * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Right index finger traumatic wound * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Right leg traumatic wound * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Right wrist scratch on posterior aspect * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Scratch * 1  1/20 (5.00%)  1 2/20 (10.00%)  2 3/20 (15.00%)  3
Scratch of anterior/external aspect of the thigh * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Sense of pulsation at injection site * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Traumatic leg wound * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Traumatic pain of left toes * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Traumatic wound of right ring fingure * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Traumatic wound of the middle finger * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Traumatic wound of the right knee * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Wound * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 4/20 (20.00%)  4
Investigations       
Elevated temperature  1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Metabolism and nutrition disorders       
Anorxia * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Edema of left anterior forearm * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Post-traumatic edema of forehead * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Acute lower back pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Acute left inferior deltoid pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Arthralgia  1  0/20 (0.00%)  0 1/20 (5.00%)  1 2/20 (10.00%)  2
Burning muscular pain * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Chills  1  6/20 (30.00%)  6 3/20 (15.00%)  3 1/20 (5.00%)  1
Coxalgy * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Hip pain * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 0/20 (0.00%)  0
Joint pain  1  2/20 (10.00%)  2 1/20 (5.00%)  1 0/20 (0.00%)  0
Limitation of arm movement  1  5/20 (25.00%)  5 3/20 (15.00%)  3 0/20 (0.00%)  0
Lombalgia * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 4/20 (20.00%)  4
Lower back pain * 1  2/20 (10.00%)  2 2/20 (10.00%)  2 0/20 (0.00%)  0
Mucsle aches * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Muscle pain of abdominal muscles and at venipuncture site * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Muscular pain of right lower extremity following trauma * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Myalgia  1  5/20 (25.00%)  5 11/20 (55.00%)  11 4/20 (20.00%)  4
Pain in anterior left forearm * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Pain of right knee * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pulled groin muscle * 1  2/20 (10.00%)  2 0/20 (0.00%)  0 0/20 (0.00%)  0
Right lumbar pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Sensation of arm heaviness * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Sensation of head heaviness * 1  0/20 (0.00%)  0 3/20 (15.00%)  3 0/20 (0.00%)  0
Nervous system disorders       
Diffuse headache  1  0/20 (0.00%)  0 2/20 (10.00%)  2 0/20 (0.00%)  0
Dizziness * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Evening headache * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Frontal headache  1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Headache  1  20/20 (100.00%)  20 17/20 (85.00%)  17 5/20 (25.00%)  5
Headache in frontal region  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Headache in temporal region  1  1/20 (5.00%)  1 3/20 (15.00%)  3 0/20 (0.00%)  0
Headaches  1  3/20 (15.00%)  3 7/20 (35.00%)  7 5/20 (25.00%)  5
Loss of balance with movement * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Migraine  1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Paroxysmal vertigo * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Torticollis * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 1/20 (5.00%)  1
Transient loss of balance * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Vertigo * 1  2/20 (10.00%)  2 1/20 (5.00%)  1 0/20 (0.00%)  0
Psychiatric disorders       
Insomnia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Renal and urinary disorders       
Burning with urination * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Pain with urination * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Urethral discharge * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 0/20 (0.00%)  0
Urinary tract infection * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 5/20 (25.00%)  5
Reproductive system and breast disorders       
Dysmenorrhea * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Left pelvic pain * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Positive urine pregnancy test * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Vulvitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Whitish leukorrhea * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Acute pharyngitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Acute rhinitis * 1  3/20 (15.00%)  3 0/20 (0.00%)  0 0/20 (0.00%)  0
Acute sinusitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Acute viral rhinitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Cold * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 7/20 (35.00%)  7
Cold symptoms * 1  13/20 (65.00%)  13 5/20 (25.00%)  5 0/20 (0.00%)  0
Cold symptoms with productive cough * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Cough * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 3/20 (15.00%)  3
Dry cough * 1  8/20 (40.00%)  8 1/20 (5.00%)  1 0/20 (0.00%)  0
Flu * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 3/20 (15.00%)  3
Frontal sinusitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Left rhinitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Nighttime cough * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Nighttime wet cough triggered by cigarette smoke * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Oropharyngitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Productive cough * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 0/20 (0.00%)  0
Rhinitis * 1  8/20 (40.00%)  8 9/20 (45.00%)  9 0/20 (0.00%)  0
Rhinitis of mucous membranes * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Rhinobronchitis * 1  2/20 (10.00%)  2 3/20 (15.00%)  3 2/20 (10.00%)  2
Rhinopharyngitis * 1  0/20 (0.00%)  0 2/20 (10.00%)  2 1/20 (5.00%)  1
Rhinosinusitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Right tonsillitis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Sinisitis + Rhinitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Sinusitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Tonsillitis * 1  4/20 (20.00%)  4 1/20 (5.00%)  1 1/20 (5.00%)  1
Viral rhinopharyngitis * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Skin and subcutaneous tissue disorders       
Abrasion from scratching * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Bilateral ocular pruritus * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Bilateral pruritus of forearms * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Boil * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Bullous pruritic lesions of upper extremities * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Erythema extending from injection site * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Furuncle * 1  1/20 (5.00%)  1 1/20 (5.00%)  1 0/20 (0.00%)  0
Generalized pruritus and skin papules * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Isolated pruritus of the umbilical region * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Non-pruritic papule * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Papule of the posterior ankle and inferior left abdominal flank * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Papule on mid-flank of right abdomen * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Papule pruritus * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 3/20 (15.00%)  3
Papule unpruritus * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 1/20 (5.00%)  1
Papules + pruritus following an insect bite * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pruritic papules * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Pruritus * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 1/20 (5.00%)  1
Pruritis of internal face of thighs * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pruritis papule * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pruritis with papules and excoriation * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Pruritis with skin abrasions from scratching * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Surgical and medical procedures       
Dental extraction * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Groin elongation * 1  0/20 (0.00%)  0 0/20 (0.00%)  0 2/20 (10.00%)  2
Gum pain following tooth extraction * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Painful dental cavity (tooth extraction) * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
post-operative pain at wound site * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Surgical hernia repair * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Vascular disorders       
Elevated blood pressure = 150/90 mmHg  1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
Epistaxis * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Hemorrhoids * 1  0/20 (0.00%)  0 1/20 (5.00%)  1 0/20 (0.00%)  0
Orthostatic hypotension * 1  1/20 (5.00%)  1 0/20 (0.00%)  0 0/20 (0.00%)  0
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
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
Name/Title: Mahamadou A. Thera, MD, MPH, Professor
Organization: University of Bamako
Phone: 223-20-22-81-09
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00349713     History of Changes
Other Study ID Numbers: 04-031
N01AI085346-006 ( U.S. NIH Grant/Contract )
N01AI085346-005 ( U.S. NIH Grant/Contract )
N01AI085346-000 ( U.S. NIH Grant/Contract )
102231 ( Malaria-037) ( Other Identifier: GSK )
HSRRB A-12855 ( Other Identifier: USAMRMC )
First Submitted: July 6, 2006
First Posted: July 10, 2006
Results First Submitted: December 20, 2016
Results First Posted: July 24, 2017
Last Update Posted: July 24, 2017