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Phase II AMA-1 Malaria Vaccine FMP2.1/AS02A Trial in Mali

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: NCT00460525
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : August 10, 2010
Last Update Posted : November 9, 2018
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: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Condition Plasmodium Falciparum Malaria
Interventions Biological: FMP2.1/AS02A
Biological: Rabies Vaccine
Enrollment 400
Recruitment Details Subjects were recruited from the population of healthy children aged 1-6 years residing in the town of Bandiagara.
Pre-assignment Details  
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description Rabies vaccine administered on Days 0, 30, and 60. 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Period Title: Overall Study
Started 201 199
Completed 190 194
Not Completed 11 5
Arm/Group Title Rabies Vaccine FMP2.1/AS02A Total
Hide Arm/Group Description Rabies vaccine administered on Days 0, 30, and 60. 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60. Total of all reporting groups
Overall Number of Baseline Participants 201 199 400
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 199 participants 400 participants
<=18 years
201
 100.0%
199
 100.0%
400
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants 199 participants 400 participants
3.4  (1.5) 3.4  (1.6) 3.4  (1.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants 199 participants 400 participants
Female
112
  55.7%
103
  51.8%
215
  53.8%
Male
89
  44.3%
96
  48.2%
185
  46.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mali Number Analyzed 201 participants 199 participants 400 participants
201 199 400
1.Primary Outcome
Title Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the First Vaccination
Hide Description Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after each vaccination. "Reported Limitation of Arm Motion" refers to the parents' report of the symptom while "Limitation of Arm Motion" refers to the clinicians' assessment of the symptom, collected separately.
Time Frame 0-7 days after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccination are included.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 201 199
Measure Type: Number
Unit of Measure: Participants
Drowsiness 0 5
Irritability/Fussiness 0 12
Loss of Appetite 3 25
Vomiting 1 4
Fever 30 61
Site Pain 55 157
Swelling 34 153
Erythema 0 12
Reported Limitation of Arm Motion 4 55
Limitation of Arm Motion 2 54
2.Primary Outcome
Title Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Second Vaccination.
Hide Description Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. "Reported Limitation of Arm Motion" refers to the parents' report of the symptom while "Limitation of Arm Motion" refers to the clinicians' assessment of the symptom, collected separately.
Time Frame 0-7 days after the second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccination are included.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 193 193
Measure Type: Number
Unit of Measure: Participants
Drowsiness 0 0
Irritability/Fussiness 1 5
Loss of Appetite 1 10
Vomiting 3 3
Fever 13 64
Site Pain 57 132
Swelling 69 151
Erythema 0 1
Reported Limitation of Arm Motion 0 31
Limitation of Arm Motion 2 37
3.Primary Outcome
Title Number of Subjects Reporting Solicited Adverse Events During the 7-day Surveillance Period After the Third Vaccination.
Hide Description Solicited symptoms were recorded by study staff at clinic visits on Days 0, 1, 2 and 7 after vaccination. "Reported Limitation of Arm Motion" refers to the parents' report of the symptom while "Limitation of Arm Motion" refers to the clinicians' assessment of the symptom, collected separately.
Time Frame 0-7 days after the third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccination are included.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 187 184
Measure Type: Number
Unit of Measure: Participants
Drowsiness 1 0
Irritability/Fussiness 2 6
Loss of Appetite Post 0 3
Vomiting 2 2
Fever 18 64
Site Pain 48 134
Swelling 90 159
Erythema 0 3
Reported Limitation of Arm Motion 4 26
Limitation of Arm Motion 2 28
4.Primary Outcome
Title Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the First Vaccination
Hide Description Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.
Time Frame Day 0-29 after first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccination are included.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 201 199
Measure Type: Number
Unit of Measure: Adverse Events
Blood and lymphatic system disorders 7 4
Ear and labyrinth disorders 0 0
Eye disorders 5 5
Gastrointestinal disorders 17 11
General disorders, administrative site conditions 16 44
Hepatobiliary disorders 2 0
Infections and infestations 56 53
Injury, poisoning, and procedural complications 5 4
Investigations 45 42
Metabolism and nutrition disorders 0 0
Musculoskeletal and connective tissue disorders 0 0
Nervous system disorders 3 2
Psychiatric disorders 0 4
Renal and urinary disorders 1 1
Reproductive system and breast disorders 1 2
Respiratory, thoracic and mediastinal disorders 23 28
Skin and subcutaneous tissue disorders 5 6
Vascular disorders 0 0
5.Primary Outcome
Title Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Second Vaccination
Hide Description Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.
Time Frame Day 0-29 after second vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccination are included.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 193 193
Measure Type: Number
Unit of Measure: Adverse Events
Blood and lymphatic system disorders 1 2
Ear and labyrinth disorders 0 1
Eye disorders 1 1
Gastrointestinal disorders 19 11
General disorders, administrative site conditions 9 26
Hepatobiliary disorders 0 0
Infections and infestations 67 68
Injury, poisoning, and procedural complications 6 3
Investigations 71 74
Metabolism and nutrition disorders 0 1
Musculoskeletal and connective tissue disorders 0 1
Nervous system disorders 0 1
Psychiatric disorders 1 1
Renal and urinary disorders 0 1
Reproductive system and breast disorders 0 1
Respiratory, thoracic and mediastinal disorders 17 16
Skin and subcutaneous tissue disorders 4 5
Vascular disorders 0 0
6.Primary Outcome
Title Number of Unsolicited Non-serious Adverse Events Reported During the 30-day Surveillance Period After the Third Vaccination
Hide Description Unsolicited non-serious adverse events reported are those occurring within 30 days after vaccination. The categories are the MedDRA System Organ Classes for which at least one adverse event was reported. All non-serious adverse events are included, regardless of severity or relationship to vaccination.
Time Frame Day 0-29 after third vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects receiving the vaccination are included.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 187 184
Measure Type: Number
Unit of Measure: Adverse Events
Blood and lymphatic system disorders 7 1
Ear and labyrinth disorders 0 0
Eye disorders 8 7
Gastrointestinal disorders 13 16
General disorders, administrative site conditions 14 29
Hepatobiliary disorders 0 0
Infections and infestations 84 73
Injury, poisoning, and procedural complications 6 5
Investigations 110 109
Metabolism and nutrition disorders 2 0
Musculoskeletal and connective tissue disorders 0 0
Nervous system disorders 5 1
Psychiatric disorders 1 1
Renal and urinary disorders 0 0
Reproductive system and breast disorders 0 0
Respiratory, thoracic and mediastinal disorders 32 36
Skin and subcutaneous tissue disorders 7 9
Vascular disorders 0 1
7.Primary Outcome
Title Time to First Clinical Malaria Episode With Significant Parasitemia (2500/mm^3) and Temperature of Greater Than or Equal to 37.5 Degrees C.
Hide Description Time to first clinical malaria episode is displayed in a life table format to display the number of subjects at risk, the number with first clinical episode and the number censored at each time point.
Time Frame Occurring between randomization and 6 months after the assigned date of the 3rd immunization.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 201 199
Measure Type: Number
Unit of Measure: Participants
Days 0 - 30, Number at Risk 201 199
Days 0 - 30, Number with First Episode 1 0
Days 0 -30, Number Censored 4 1
Days 31 - 60, Number at Risk 196 198
Days 31 - 60, Number with First Episode 9 10
Days 31 - 60, Number Censored 1 0
Days 61 - 90 Number at Risk 186 188
Days 61 - 90, Number with First Episode 40 25
Days 61 - 90, Number Censored 0 1
Days 91 - 120, Number at Risk 146 162
Days 91 - 120, Number with First Episode 28 33
Days 91 - 120, Number Censored 0 0
Days 121 - 150, Number at Risk 118 129
Days 121 - 150, Number with First Episode 16 10
Days 121 - 150, Number Censored 1 1
Days 151 - 180, Number at Risk 101 118
Days 151 - 180, Number with First Episode 5 9
Days 151 - 180, Number Censored 2 1
Days 181 - 210, Number at Risk 94 108
Days 181 - 210, Number with First Episode 5 5
Days 181 - 210, Number Censored 0 0
Days 211 - 240, Number at Risk 89 103
Days 211 - 240, Number with First Episode 2 3
Days 211 - 240, Number Censored 87 100
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rabies Vaccine, FMP2.1/AS02A
Comments Time to first clinical malaria episode with significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C was analyzed by fitting a Cox Proportional Hazards model. The null hypothesis of no vaccine efficacy was tested by the stratified log-rank test (score test). The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.175
Comments The a priori threshold for statistical significance was set at 0.05.
Method Regression, Cox
Comments No adjustments were made.
Method of Estimation Estimation Parameter Vaccine Efficacy, VE=1-RR=1-exp(ß)
Estimated Value 0.17
Confidence Interval 95%
-0.09 to 0.37
Estimation Comments Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Cox model fit.
8.Primary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description A serious adverse event was defined as any untoward medical occurrence that results in death, is life threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or prolongation of existing hospitalization or is a congenital anomaly/birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the participant or may require intervention to prevent one of the other outcomes listed above was considered serious.
Time Frame 24 months after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 201 199
Measure Type: Number
Unit of Measure: Participants
2 8
9.Secondary Outcome
Title Incidence Density of Clinical Malaria Episode
Hide Description Clinical malaria episode was defined by significant parasitemia (2500/mm^3) and temperature of greater than or equal to 37.5 degrees C. Event rate was determined by dividing the number of episodes (150 for the Rabies group and 121 for the FMP2.1/ASO2A group) by the number of Person Years at Risk (PYAR) (126.341 for Rabies group and 127.411 for the FMP2.1/ASO2A group).
Time Frame Between randomization and 6 months after 3rd immunization.
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 201 199
Measure Type: Number
Unit of Measure: Events Per PYAR
1.187263 0.949683
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rabies Vaccine, FMP2.1/AS02A
Comments Incidence density, defined as number of clinical malaria episodes per PYAR, was compared using Poisson regression. The null hypothesis of no vaccine efficacy was tested. The point and interval estimates for vaccine efficacy were obtained by transforming those for treatment effect in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments The a priori threshold for statistical significance was set at 0.05.
Method Poisson regression
Comments No adjustments
Method of Estimation Estimation Parameter Vaccine Efficacy, VE=1-RR=1-exp(ß)
Estimated Value 0.20
Confidence Interval 95%
-0.02 to 0.37
Estimation Comments Vaccine efficacy (VE) was defined as one minus the relative risk (RR), which was estimated by exponentiating the treatment parameter (ß) from the Poisson model fit.
10.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by Enzyme Linked ImmunoSorbent Assay (ELISA) at Day 0
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 0 prior to the first vaccination.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 201 199
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
430.4
(298.0 to 621.4)
393.1
(273.2 to 565.5)
11.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 30.
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 30, prior to the second vaccination.
Time Frame Day 30 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 195 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
403.7
(275.8 to 591.0)
21248.7
(17616.8 to 25629.5)
12.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 60.
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 60, prior to the third vaccination.
Time Frame Day 60 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 194 195
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
512.2
(350.1 to 749.3)
98199.0
(86574.6 to 111384.1)
13.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 90.
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 90.
Time Frame Day 90 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 191 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
781.8
(524.8 to 1164.5)
188449.1
(165625.5 to 214417.8)
14.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 150.
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 150.
Time Frame Day 150 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 188 194
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
1202.9
(813.3 to 1779.0)
100746.5
(85163.0 to 119181.5)
15.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 240.
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 240.
Time Frame Day 240 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 189 193
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
774.6
(525.5 to 1141.8)
65031.7
(54999.2 to 76894.4)
16.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 364
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 364.
Time Frame Day 364 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 185 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
505.0
(353.9 to 720.5)
42596.8
(36549.9 to 49644.1)
17.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 547
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 547.
Time Frame Day 547 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 183 183
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
1589.3
(1075.0 to 2349.7)
81205.1
(66166.2 to 99662.1)
18.Secondary Outcome
Title Geometric Mean Titers of Anti-FMP2.1 Antibody Measured by ELISA at Day 730
Hide Description Titers of Anti-FMP2.1 antibody were determined by ELISA from sera collected at Day 730.
Time Frame Day 730 after initial vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Analyses are ITT. No imputation techniques were used.
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description:
Rabies vaccine administered on Days 0, 30, and 60.
50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
Overall Number of Participants Analyzed 168 179
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
636.5
(431.4 to 939.0)
40605.3
(33946.8 to 48569.8)
Time Frame Solicited adverse events were collected for 7 days after each immunization. Serious adverse events and unsolicited non-serious adverse events were collected for 24 months after initial vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rabies Vaccine FMP2.1/AS02A
Hide Arm/Group Description Rabies vaccine administered on Days 0, 30, and 60. 50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
All-Cause Mortality
Rabies Vaccine FMP2.1/AS02A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Rabies Vaccine FMP2.1/AS02A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/201 (1.00%)      8/199 (4.02%)    
Gastrointestinal disorders     
Ileus paralytic * 2  0/201 (0.00%)  0 1/199 (0.50%)  1
General disorders     
Pyrexia * 2  0/201 (0.00%)  0 1/199 (0.50%)  1
Infections and infestations     
Malaria * 1  0/201 (0.00%)  0 2/199 (1.01%)  2
Cerebral malaria * 2  0/201 (0.00%)  0 1/199 (0.50%)  1
Metabolism and nutrition disorders     
Dehydration * 2  0/201 (0.00%)  0 1/199 (0.50%)  1
Nervous system disorders     
Febrile Convulsion * 3  0/201 (0.00%)  0 1/199 (0.50%)  1
Status epilepticus * 2  1/201 (0.50%)  1 0/199 (0.00%)  0
Febrile convulsion * 3  1/201 (0.50%)  1 0/199 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory distress * 4  0/201 (0.00%)  0 1/199 (0.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
2
Term from vocabulary, MedDRA (11.0)
3
Term from vocabulary, MedDRA (10.1)
4
Term from vocabulary, MedDRA (9.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rabies Vaccine FMP2.1/AS02A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   198/201 (98.51%)      199/199 (100.00%)    
Eye disorders     
Conjunctivitis * 1  55/201 (27.36%)  71 49/199 (24.62%)  61
Gastrointestinal disorders     
Abdominal Pain * 1  39/201 (19.40%)  57 45/199 (22.61%)  74
Diarrhoea * 1  64/201 (31.84%)  96 48/199 (24.12%)  81
Vomiting * 2  17/201 (8.46%)  20 24/199 (12.06%)  30
General disorders     
Pyrexia * 3  50/201 (24.88%)  65 89/199 (44.72%)  120
Injection site erythema  7  0/201 (0.00%)  0 13/199 (6.53%)  13
Injection site pain  7  92/201 (45.77%)  114 180/199 (90.45%)  324
Injection site swelling  7  129/201 (64.18%)  167 192/199 (96.48%)  438
Irritability  7  1/201 (0.50%)  1 17/199 (8.54%)  19
Pyrexia  7  46/201 (22.89%)  52 104/199 (52.26%)  133
Infections and infestations     
Bronchitis * 4  126/201 (62.69%)  273 121/199 (60.80%)  259
Ear infection * 2  47/201 (23.38%)  65 46/199 (23.12%)  55
Fungal skin infection * 2  27/201 (13.43%)  31 24/199 (12.06%)  27
Furuncle * 1  18/201 (8.96%)  18 17/199 (8.54%)  20
Mumps * 3  19/201 (9.45%)  19 12/199 (6.03%)  12
Nasopharyngitis * 3  43/201 (21.39%)  59 41/199 (20.60%)  54
Pharyngitis * 5  31/201 (15.42%)  32 33/199 (16.58%)  40
Pneumonia * 5  31/201 (15.42%)  37 33/199 (16.58%)  42
Pyoderma * 6  54/201 (26.87%)  71 60/199 (30.15%)  89
Rhinitis * 3  127/201 (63.18%)  244 123/199 (61.81%)  251
Salmonellosis * 7  11/201 (5.47%)  13 5/199 (2.51%)  5
Staphylococcal infection * 3  12/201 (5.97%)  12 11/199 (5.53%)  11
Tinea capitis * 2  30/201 (14.93%)  36 26/199 (13.07%)  27
Tonsillitis * 5  19/201 (9.45%)  22 18/199 (9.05%)  22
Trichomoniasis intestinal * 4  12/201 (5.97%)  13 19/199 (9.55%)  21
Varicella * 4  57/201 (28.36%)  57 49/199 (24.62%)  50
Injury, poisoning and procedural complications     
Wound * 1  39/201 (19.40%)  51 41/199 (20.60%)  49
Investigations     
Alanine aminotransferase increased * 6  12/201 (5.97%)  13 10/199 (5.03%)  11
Granulocyte count increased * 4  36/201 (17.91%)  37 24/199 (12.06%)  24
Haemoglobin increased * 2  94/201 (46.77%)  145 92/199 (46.23%)  143
Lymphocyte count decreased * 3  12/201 (5.97%)  12 13/199 (6.53%)  14
Lymphocyte count increased * 3  10/201 (4.98%)  12 16/199 (8.04%)  16
Platelet count increased * 3  47/201 (23.38%)  60 59/199 (29.65%)  80
Red blood cell count increased * 2  15/201 (7.46%)  16 4/199 (2.01%)  5
White blood cell count decreased * 3  18/201 (8.96%)  21 17/199 (8.54%)  19
White blood cell count increased * 3  17/201 (8.46%)  19 18/199 (9.05%)  19
Metabolism and nutrition disorders     
Anorexia * 2  11/201 (5.47%)  11 4/199 (2.01%)  4
Anorexia  7  4/201 (1.99%)  4 32/199 (16.08%)  35
Nervous system disorders     
Headache * 3  25/201 (12.44%)  34 30/199 (15.08%)  36
Respiratory, thoracic and mediastinal disorders     
Cough * 3  109/201 (54.23%)  166 104/199 (52.26%)  190
Rhinorrhoea * 5  39/201 (19.40%)  46 28/199 (14.07%)  30
Skin and subcutaneous tissue disorders     
Rash papular * 7  7/201 (3.48%)  8 11/199 (5.53%)  13
Skin lesion * 7  6/201 (2.99%)  8 11/199 (5.53%)  11
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (12.1)
2
Term from vocabulary, MedDRA (11.0)
3
Term from vocabulary, MedDRA (10.1)
4
Term from vocabulary, MedDRA (10.0)
5
Term from vocabulary, MedDRA (9.0)
6
Term from vocabulary, MedDRA (9.1)
7
Term from vocabulary, MedDRA (12.0)
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mahamadou A. Thera, MD, MPH
Organization: Department of Epidemiology of Parasitic Diseases, University of Bamako
Phone: 223-222-8109
EMail: mthera@mrtcbko.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT00460525    
Other Study ID Numbers: 07-0003
U01AI065683 ( U.S. NIH Grant/Contract )
2U01AI065683-06 ( U.S. NIH Grant/Contract )
Malaria-056 (110060) ( Other Identifier: GSK )
HSRRB # A-14262 ( Other Identifier: USAMRMC )
First Submitted: April 12, 2007
First Posted: April 16, 2007
Results First Submitted: July 2, 2010
Results First Posted: August 10, 2010
Last Update Posted: November 9, 2018