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Phase I Pediatric 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: NCT00358332
Recruitment Status : Completed
First Posted : July 31, 2006
Results First Posted : March 4, 2009
Last Update Posted : October 24, 2011
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Walter Reed Army Institute of Research (WRAIR)
GlaxoSmithKline
University of Maryland, Baltimore
Information provided by:
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Prevention
Condition Plasmodium Falciparum Malaria
Interventions Biological: FMP2.1/AS02A
Biological: Rabies vaccine (RabAvert)
Enrollment 100
Recruitment Details Parents in Bandiagara Mali were made aware of the study by a radio announcement and voluntarily brought their children to the Bandiagara Malaria Project (BMP) clinic on the campus of the Bandiagara District Hospital in Bandiagara, Mali. The first subject was enrolled on November 3, 2006 and the final subject was enrolled on December 12, 2006.
Pre-assignment Details  
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Period Title: Overall Study
Started 15 30 30 25
Completed 15 27 29 25
Not Completed 0 3 1 0
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R) Total
Hide Arm/Group Description Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60. Total of all reporting groups
Overall Number of Baseline Participants 15 30 30 25 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 30 participants 30 participants 25 participants 100 participants
<=18 years
15
 100.0%
30
 100.0%
30
 100.0%
25
 100.0%
100
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
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 15 participants 30 participants 30 participants 25 participants 100 participants
3.5  (1.8) 3.5  (1.7) 3.6  (1.7) 3.2  (1.9) 3.4  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 30 participants 30 participants 25 participants 100 participants
Female
7
  46.7%
15
  50.0%
12
  40.0%
15
  60.0%
49
  49.0%
Male
8
  53.3%
15
  50.0%
18
  60.0%
10
  40.0%
51
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Mali Number Analyzed 15 participants 30 participants 30 participants 25 participants 100 participants
15 30 30 25 100
1.Primary Outcome
Title Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Hide Description The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions.
Time Frame 7 Days following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome includes all enrolled subjects.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 30 25
Measure Type: Number
Unit of Measure: Participants
Drowsiness 0 0 0 0
Irritability/Fussiness 0 0 0 0
Loss of Appetite 3 0 1 0
Vomiting 2 0 0 0
Feverishness 3 17 16 4
2.Primary Outcome
Title Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60.
Hide Description The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions.
Time Frame Day of vaccination and 30 subsequent days.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome includes all enrolled subjects.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 30 25
Measure Type: Number
Unit of Measure: Participants
4 7 10 2
3.Primary Outcome
Title Number of Subjects Spontaneously Reporting Any Serious Adverse Event.
Hide Description Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes.
Time Frame 1 year after the last vaccination.
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome includes all enrolled subjects.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 30 25
Measure Type: Number
Unit of Measure: Participants
1 1 0 2
4.Primary Outcome
Title Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60.
Hide Description The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions.
Time Frame 7 Days following any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome includes all enrolled subjects.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 30 25
Measure Type: Number
Unit of Measure: Participants
Site Pain 11 27 27 6
Swelling 13 28 30 11
Erythema 0 0 1 0
5.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 0
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 30 25
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
2.73
(1.99 to 3.47)
2.70
(2.22 to 3.17)
3.04
(2.65 to 3.42)
2.66
(2.18 to 3.14)
6.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 30 +/- 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 29 24
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
4.09
(3.78 to 4.41)
4.20
(4.04 to 4.36)
4.31
(4.18 to 4.44)
2.57
(2.05 to 3.09)
7.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 60 +/- 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 29 24
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
4.78
(4.61 to 4.96)
4.98
(4.84 to 5.11)
4.97
(4.89 to 5.05)
2.53
(2.03 to 3.03)
8.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 90 +/- 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 30 29 25
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
4.93
(4.75 to 5.11)
5.22
(5.06 to 5.37)
5.05
(4.91 to 5.19)
2.41
(1.98 to 2.84)
9.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 180 +/- 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 29 29 25
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
4.53
(4.33 to 4.73)
4.73
(4.60 to 4.86)
4.57
(4.42 to 4.72)
2.15
(1.75 to 2.54)
10.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272.
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 272 +/- 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 14 29 29 25
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
4.25
(4.05 to 4.45)
4.43
(4.29 to 4.58)
4.51
(4.33 to 4.70)
2.13
(1.78 to 2.48)
11.Secondary Outcome
Title Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364
Hide Description This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
Time Frame Day 364 +/- 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available.
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description:
Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
Overall Number of Participants Analyzed 15 27 29 25
Mean (95% Confidence Interval)
Unit of Measure: log anti-FMP2.1 titer
4.36
(4.16 to 4.56)
4.68
(4.46 to 4.91)
4.42
(4.27 to 4.57)
2.56
(2.20 to 2.92)
Time Frame Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
Adverse Event Reporting Description The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
 
Arm/Group Title FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Hide Arm/Group Description Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
All-Cause Mortality
FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      1/30 (3.33%)      0/30 (0.00%)      2/25 (8.00%)    
Investigations         
Alanine aminotransferase increased * 1  0/15 (0.00%)  0 1/30 (3.33%)  1 0/30 (0.00%)  0 2/25 (8.00%)  2
White blood cell count increased * 2  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
2
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FMP2.1/AS02A 10 Mcg FMP2.1/AS02A 25 Mcg FMP2.1/AS02A 50 Mcg RabAvert(R)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      30/30 (100.00%)      30/30 (100.00%)      25/25 (100.00%)    
Blood and lymphatic system disorders         
Anaemia * 1  1/15 (6.67%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 1/25 (4.00%)  1
Lymphadenopathy * 2  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Splenomegaly * 1  2/15 (13.33%)  2 2/30 (6.67%)  2 0/30 (0.00%)  0 1/25 (4.00%)  2
Cardiac disorders         
Tachycardia * 3  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Ear and labyrinth disorders         
Cerumen impaction * 4  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Eye disorders         
Conjunctivitis * 1  2/15 (13.33%)  8 3/30 (10.00%)  3 7/30 (23.33%)  8 5/25 (20.00%)  5
Conjunctivitis allergic * 5  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Eye pruritus * 3  2/15 (13.33%)  2 0/30 (0.00%)  0 0/30 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders         
Abdominal pain * 2  2/15 (13.33%)  2 12/30 (40.00%)  13 4/30 (13.33%)  4 1/25 (4.00%)  1
Aphthous stomatitis * 5  0/15 (0.00%)  0 2/30 (6.67%)  2 0/30 (0.00%)  0 0/25 (0.00%)  0
Dental caries * 4  2/15 (13.33%)  2 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Dental discomfort * 4  0/15 (0.00%)  0 1/30 (3.33%)  1 2/30 (6.67%)  2 0/25 (0.00%)  0
Diarrhoea * 5  4/15 (26.67%)  9 8/30 (26.67%)  18 10/30 (33.33%)  14 9/25 (36.00%)  17
Diarrhoea haemorrhagic * 2  0/15 (0.00%)  0 1/30 (3.33%)  1 2/30 (6.67%)  2 0/25 (0.00%)  0
Gingivitis * 1  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 1/25 (4.00%)  1
Oral disorder * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 1/25 (4.00%)  1
Rectal prolapse * 5  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Salivary hypersecretion * 1  1/15 (6.67%)  2 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Stomatitis * 3  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Tooth loss * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Umbilical hernia * 2  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Vomiting * 5  1/15 (6.67%)  2 5/30 (16.67%)  5 1/30 (3.33%)  1 2/25 (8.00%)  3
Pyrexia * 4  4/15 (26.67%)  6 9/30 (30.00%)  13 4/30 (13.33%)  5 3/25 (12.00%)  3
Vomiting – post dose 1  6  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Vomiting – post dose 3  6  1/14 (7.14%)  1 0/27 (0.00%)  0 0/27 (0.00%)  0 0/23 (0.00%)  0
General disorders         
Asthenia * 1  0/15 (0.00%)  0 0/30 (0.00%)  0 2/30 (6.67%)  2 0/25 (0.00%)  0
Injection site pain – post dose 1  6  8/15 (53.33%)  8 19/30 (63.33%)  19 16/30 (53.33%)  16 2/25 (8.00%)  2
Injection site swelling – post dose 1  6  11/15 (73.33%)  11 12/30 (40.00%)  12 28/30 (93.33%)  28 6/25 (24.00%)  6
Pyrexia – post dose 1  6  0/15 (0.00%)  0 9/30 (30.00%)  9 8/30 (26.67%)  8 0/25 (0.00%)  0
Injection site pain – post dose 2  6  7/15 (46.67%)  7 15/30 (50.00%)  15 19/28 (67.86%)  19 4/25 (16.00%)  4
Injection site swelling – post dose 2  6  7/15 (46.67%)  7 22/30 (73.33%)  22 22/28 (78.57%)  22 4/25 (16.00%)  4
Pyrexia – post dose 2  6  2/15 (13.33%)  2 8/30 (26.67%)  8 6/28 (21.43%)  6 2/25 (8.00%)  2
Injection site pain – post dose 3  6  3/14 (21.43%)  3 12/27 (44.44%)  12 16/27 (59.26%)  16 1/23 (4.35%)  1
Injection site swelling - – post dose 3  6  10/14 (71.43%)  10 16/27 (59.26%)  16 23/27 (85.19%)  23 3/23 (13.04%)  3
Pyrexia – post dose 3  6  2/14 (14.29%)  2 5/27 (18.52%)  5 7/27 (25.93%)  7 4/23 (17.39%)  4
Hepatobiliary disorders         
Jaundice * 2  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Infections and infestations         
Amoebic dysentery * 1  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 1/25 (4.00%)  1
Bronchiolitis * 1  0/15 (0.00%)  0 2/30 (6.67%)  2 0/30 (0.00%)  0 2/25 (8.00%)  2
Bronchitis * 1  6/15 (40.00%)  14 11/30 (36.67%)  19 12/30 (40.00%)  20 11/25 (44.00%)  18
Candidiasis * 4  0/15 (0.00%)  0 2/30 (6.67%)  3 0/30 (0.00%)  0 1/25 (4.00%)  1
Ear infection * 5  5/15 (33.33%)  6 12/30 (40.00%)  15 6/30 (20.00%)  7 10/25 (40.00%)  11
Fungal skin infection * 3  5/15 (33.33%)  5 5/30 (16.67%)  7 9/30 (30.00%)  9 4/25 (16.00%)  4
Furuncle * 4  1/15 (6.67%)  1 2/30 (6.67%)  3 3/30 (10.00%)  3 2/25 (8.00%)  3
Gastroenteritis * 5  1/15 (6.67%)  1 3/30 (10.00%)  3 0/30 (0.00%)  0 3/25 (12.00%)  3
Giardiasis * 5  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Hepatitis A * 3  1/15 (6.67%)  1 1/30 (3.33%)  1 1/30 (3.33%)  1 1/25 (4.00%)  1
Herpetic stomatitis * 3  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Hymenolepiasis * 2  1/15 (6.67%)  1 1/30 (3.33%)  1 2/30 (6.67%)  2 0/25 (0.00%)  0
Infection parasitic * 3  1/15 (6.67%)  1 2/30 (6.67%)  2 0/30 (0.00%)  0 0/25 (0.00%)  0
Malaria * 4  10/15 (66.67%)  20 16/30 (53.33%)  25 21/30 (70.00%)  28 15/25 (60.00%)  25
Mumps * 5  0/15 (0.00%)  0 0/30 (0.00%)  0 4/30 (13.33%)  4 0/25 (0.00%)  0
Nasopharyngitis * 1  10/15 (66.67%)  14 13/30 (43.33%)  22 15/30 (50.00%)  19 15/25 (60.00%)  28
Oral herpes * 5  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Otitis media * 2  2/15 (13.33%)  2 3/30 (10.00%)  3 1/30 (3.33%)  1 5/25 (20.00%)  7
Pharyngitis * 3  5/15 (33.33%)  5 4/30 (13.33%)  6 5/30 (16.67%)  5 4/25 (16.00%)  4
Pneumonia * 1  1/15 (6.67%)  1 1/30 (3.33%)  1 4/30 (13.33%)  4 3/25 (12.00%)  3
Pyoderma * 3  5/15 (33.33%)  8 8/30 (26.67%)  8 8/30 (26.67%)  8 10/25 (40.00%)  10
Rhinitis * 5  13/15 (86.67%)  27 17/30 (56.67%)  30 22/30 (73.33%)  42 20/25 (80.00%)  39
Skin infection * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Streptococcal infection * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Tonsillitis * 3  6/15 (40.00%)  7 4/30 (13.33%)  5 7/30 (23.33%)  7 6/25 (24.00%)  7
Tooth abscess * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 1/30 (3.33%)  1 0/25 (0.00%)  0
Trichomoniasis intestinal * 4  2/15 (13.33%)  2 3/30 (10.00%)  4 3/30 (10.00%)  4 1/25 (4.00%)  1
Typhoid fever * 3  0/15 (0.00%)  0 3/30 (10.00%)  3 0/30 (0.00%)  0 1/25 (4.00%)  1
Urinary tract infection * 4  1/15 (6.67%)  1 1/30 (3.33%)  1 0/30 (0.00%)  0 0/25 (0.00%)  0
Vulvovaginitis * 3  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 1/25 (4.00%)  1
Wound infection * 4  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Injury, poisoning and procedural complications         
Forearm fracture * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Injury * 1  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 1/25 (4.00%)  1
Joint injury * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Thermal burn * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 1/30 (3.33%)  1 0/25 (0.00%)  0
Wound * 2  3/15 (20.00%)  3 6/30 (20.00%)  6 5/30 (16.67%)  5 2/25 (8.00%)  2
Investigations         
Alanine aminotransferase increased * 3  1/15 (6.67%)  1 0/30 (0.00%)  0 2/30 (6.67%)  2 0/25 (0.00%)  0
Cardiac murmur * 1  0/15 (0.00%)  0 2/30 (6.67%)  2 0/30 (0.00%)  0 0/25 (0.00%)  0
Lymphocyte count decreased * 4  0/15 (0.00%)  0 1/30 (3.33%)  1 1/30 (3.33%)  1 2/25 (8.00%)  2
White blood cell count increased * 3  1/15 (6.67%)  1 0/30 (0.00%)  0 3/30 (10.00%)  4 2/25 (8.00%)  3
Metabolism and nutrition disorders         
Pica * 3  0/15 (0.00%)  0 2/30 (6.67%)  3 0/30 (0.00%)  0 1/25 (4.00%)  1
Anorexia – post dose 1  6  2/15 (13.33%)  2 0/30 (0.00%)  0 1/30 (3.33%)  1 0/25 (0.00%)  0
Anorexia – post dose 2  6  2/15 (13.33%)  2 0/30 (0.00%)  0 0/28 (0.00%)  0 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Joint range of motion decreased * 2  0/15 (0.00%)  0 0/30 (0.00%)  0 2/30 (6.67%)  2 0/25 (0.00%)  0
Nervous system disorders         
Convulsion * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Headache * 3  2/15 (13.33%)  3 6/30 (20.00%)  8 2/30 (6.67%)  2 0/25 (0.00%)  0
Somnolence * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough * 3  11/15 (73.33%)  15 24/30 (80.00%)  39 17/30 (56.67%)  26 18/25 (72.00%)  34
Rhinorrhoea * 4  8/15 (53.33%)  8 11/30 (36.67%)  17 11/30 (36.67%)  14 9/25 (36.00%)  13
Skin and subcutaneous tissue disorders         
Eczema * 5  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Prurigo * 3  2/15 (13.33%)  2 2/30 (6.67%)  2 0/30 (0.00%)  0 1/25 (4.00%)  1
Rash papular * 5  1/15 (6.67%)  1 3/30 (10.00%)  3 0/30 (0.00%)  0 1/25 (4.00%)  1
Skin lesion * 5  2/15 (13.33%)  2 3/30 (10.00%)  4 2/30 (6.67%)  2 1/25 (4.00%)  1
Skin ulcer * 1  1/15 (6.67%)  1 0/30 (0.00%)  0 0/30 (0.00%)  0 0/25 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.0)
2
Term from vocabulary, MedDRA (11.0)
3
Term from vocabulary, MedDRA (9.1)
4
Term from vocabulary, MedDRA (10.0)
5
Term from vocabulary, MedDRA (10.1)
6
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
Name/Title: Christopher V. Plowe
Organization: University of Maryland School of Medicine
Phone: 410-706-3082
Responsible Party: Director, ORA, HHS/NIAID/DMID
ClinicalTrials.gov Identifier: NCT00358332     History of Changes
Other Study ID Numbers: 05-0146
U19AI065683 ( U.S. NIH Grant/Contract )
2U01AI065683-06 ( U.S. NIH Grant/Contract )
GSKBio: Malaria 051 (106874)
First Submitted: July 27, 2006
First Posted: July 31, 2006
Results First Submitted: December 9, 2008
Results First Posted: March 4, 2009
Last Update Posted: October 24, 2011