Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
Sponsor
U.S. Army Medical Research and Development Command (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00317473
Collaborator
Kenya Medical Research Institute (Other), Walter Reed Army Institute of Research (WRAIR) (U.S. Fed), The PATH Malaria Vaccine Initiative (MVI) (Other), United States Agency for International Development (USAID) (U.S. Fed), GlaxoSmithKline (Industry)
135
1
4
25
5.4
Study Details
Study Description
Brief Summary
To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Study consists of 3 cohorts (12 to 23 months, 24 to 35 months, and 36 to 47 months). Within each cohort subjects were randomized in a 2:1 ration to receive one of three dose levels of FMP1/AS02A (Cohort A, 10 ug; Cohort B, 25 ug; Cohort C, 50 ug) or Imovax Rabies vaccine. Immunization was staggered among dose cohorts; subjects in Cohort B received their first immunization only after the Local Medical Monitor and Data Safety Monitoring Board reviewed Cohort A safety data for the eight-day follow-up period following their first immunization. The same procedure was followed for the immunization of Cohort C. This will be conducted in western Kenya a the Walter Reed Project Lumbewa Clinic.
Study Design
Study Type:
Interventional
Actual Enrollment
:
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Double-blind,Randomized,Controlled,Dose Escalation Phase 1 Trial in 12-47 Month Old Children in Western Kenya to Evaluate the Safety and Immunogenicity of WRAIR's MSP-1(FMP1) Malaria Vaccine Adjuvanted in GSK's AS02A Versus Rabies Vaccine.
Study Start Date
:
Jun 1, 2003
Actual Primary Completion Date
:
Jul 1, 2004
Actual Study Completion Date
:
Jul 1, 2005
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FMP1/AS02A Malaria vaccine 10ug Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57 |
Biological: FMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
|
| Experimental: FMP1/AS02A Malaria vaccine 25 ug Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70 |
Biological: FMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
|
| Experimental: FMP1/AS02A Malaria vaccine 50 ug Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84 |
Biological: FMP1/AS02A Malaria vaccine
Subjects vaccinated with FMP1/AS02 vaccine
|
| Active Comparator: Imovax Rabies Vaccine Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days |
Biological: Imovax Rabies vaccine
Subjects vaccinated on corresponding FMP1/AS02A vaccination days
|
Outcome Measures
Primary Outcome Measures
- Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination [40 days]
Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period
- Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination [90 days]
Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days)
- Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine [8 months]
Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine
Secondary Outcome Measures
- Anti-FMP1 Antibody Titer Responses [364 days]
Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 47 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
A healthy male or female child, 12 to 47 months of age at the time of screening.
-
Written informed consent obtained from at least one parent before study start.
-
Available to participate for the duration of the study (12 months).
Exclusion Criteria:
-
Acute disease at the time of entry into the study
-
Axillary temperature of 37.5 degrees C
-
Respiratory rate 50
-
Serum ALT 45 IU/l (i.e., > 1.5 X ULN)
-
Decreased renal function: serum creatinine levels > 92.2 mM/l (> 1.1 mg/dl).
-
Significant anemia (Hgb <8 gm/dL).
-
Thrombocytopenia (Platelets < 100,000 per mm3)
-
Impaired immunity: (Absolute lymphocyte count [ALC] for 1 year olds < 4.0 x 103/mm3; for 2 year olds < 3.0 x 103/mm3; for 3 year olds < 2.0 103/mm3.
-
History of homozygous sickle cell disease (SS).
-
Malnutrition (Z score; Malnutrition = Weight for height < - 3 z scores)
-
Blood transfusion or use of blood-based product in previous 6 months.
-
Prior receipt of a rabies vaccine or an investigational malaria vaccine.
-
Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
-
Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within six months of vaccination. (For cortico-steroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
-
Administration or anticipated administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
-
Previous vaccination with a vaccine containing MPL or QS21 (e.g., RTS,S).
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV testing will be undertaken as part of this study.)
-
History of allergic reactions or anaphylaxis to immunizations or to any vaccine components.
-
History of surgical splenectomy.
-
Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
-
Simultaneous participation in any other clinical trial.
-
Acute or chronic cardiovascular, pulmonary, hepatic or renal condition, which in the opinion of the PI may increase the risk to the subject from participating in the study.
-
Any other condition or circumstance that in the opinion of the investigator may pose a threat to the subject.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Walter Reed Project Kombewa Clinic | Kombewa | Nyanza Province | Kenya |
Sponsors and Collaborators
- U.S. Army Medical Research and Development Command
- Kenya Medical Research Institute
- Walter Reed Army Institute of Research (WRAIR)
- The PATH Malaria Vaccine Initiative (MVI)
- United States Agency for International Development (USAID)
- GlaxoSmithKline
Investigators
- Principal Investigator: Mark R. Withers, M.D., MPH, USAMRU-K
Study Documents (Full-Text)
None provided.More Information
Publications
- Ockenhouse CF, Angov E, Kester KE, Diggs C, Soisson L, Cummings JF, Stewart AV, Palmer DR, Mahajan B, Krzych U, Tornieporth N, Delchambre M, Vanhandenhove M, Ofori-Anyinam O, Cohen J, Lyon JA, Heppner DG; MSP-1 Working Group. Phase I safety and immunogenicity trial of FMP1/AS02A, a Plasmodium falciparum MSP-1 asexual blood stage vaccine. Vaccine. 2006 Apr 5;24(15):3009-17. Epub 2005 Nov 28.
- Pichyangkul S, Gettayacamin M, Miller RS, Lyon JA, Angov E, Tongtawe P, Ruble DL, Heppner DG Jr, Kester KE, Ballou WR, Diggs CL, Voss G, Cohen JD, Walsh DS. Pre-clinical evaluation of the malaria vaccine candidate P. falciparum MSP1(42) formulated with novel adjuvants or with alum. Vaccine. 2004 Sep 28;22(29-30):3831-40.
- Stoute JA, Gombe J, Withers MR, Siangla J, McKinney D, Onyango M, Cummings JF, Milman J, Tucker K, Soisson L, Stewart VA, Lyon JA, Angov E, Leach A, Cohen J, Kester KE, Ockenhouse CF, Holland CA, Diggs CL, Wittes J, Heppner DG Jr; MSP-1 Malaria Vaccine Working Group. Phase 1 randomized double-blind safety and immunogenicity trial of Plasmodium falciparum malaria merozoite surface protein FMP1 vaccine, adjuvanted with AS02A, in adults in western Kenya. Vaccine. 2007 Jan 2;25(1):176-84. Epub 2005 Dec 7.
Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT00317473
Other Study ID Numbers:
- WRAIR 1030
- HSRRB Log No. A-12094
- KEMRI SSC No. 761
- HSPC No. HS171
First Posted:
Apr 24, 2006
Last Update Posted:
Oct 2, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by U.S. Army Medical Research and Development Command
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subject were randomized in a 2:1 ratio between the FMP1/AS02A and Imovax vaccine groups. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | FMP1/AS02A Malaria Vaccine 10ug (Cohort A) | Imovax (Cohort A) | FMP1/AS02A Malaria Vaccine 25 ug (Cohort B) | Imovax (Cohort B) | FMP1/AS02A Malaria Vaccine 50 ug (Cohort C) | Imovax (Cohort C) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days |
| Period Title: Overall Study | ||||||
| STARTED | 30 | 15 | 30 | 15 | 30 | 15 |
| COMPLETED | 26 | 12 | 27 | 13 | 22 | 12 |
| NOT COMPLETED | 4 | 3 | 3 | 2 | 8 | 3 |
Baseline Characteristics
| Arm/Group Title | FMP1/AS02A Malaria Vaccine 10ug (Cohort A) | Imovax (Cohort A) | FMP1/AS02A Malaria Vaccine 25 ug (Cohort B) | Imovax (Cohort B) | FMP1/AS02A Malaria Vaccine 50 ug (Cohort C) | Imovax (Cohort C) | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days | Total of all reporting groups |
| Overall Participants | 29 | 15 | 30 | 15 | 30 | 15 | 134 |
| Age (Months) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Months] |
28.5
(9.6)
|
28.8
(9.7)
|
29.5
(10.9)
|
29.9
(11.2)
|
29.0
(9.9)
|
29.2
(10.9)
|
29.0
(10.1)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
17
58.6%
|
8
53.3%
|
19
63.3%
|
9
60%
|
13
43.3%
|
10
66.7%
|
76
56.7%
|
| Male |
12
41.4%
|
7
46.7%
|
11
36.7%
|
6
40%
|
17
56.7%
|
5
33.3%
|
58
43.3%
|
| Region of Enrollment (participants) [Number] | |||||||
| Kenya |
29
100%
|
15
100%
|
30
100%
|
15
100%
|
30
100%
|
15
100%
|
134
100%
|
| Temperature (celcius) (Celcius) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Celcius] |
36.36
(0.42)
|
36.30
(36.49)
|
36.49
(0.57)
|
36.46
(0.51)
|
36.50
(0.62)
|
36.85
(0.65)
|
36.45
(0.54)
|
| Pulse (bpm) (beats per minute (bpm)) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [beats per minute (bpm)] |
111.8
(21.4)
|
102.7
(24.4)
|
108.8
(14.1)
|
116.5
(18.0)
|
102.9
(17.3)
|
119.7
(19.0)
|
107.8
(18.0)
|
| Respiratory rate (bpm) (breaths per minute (bpm)) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [breaths per minute (bpm)] |
31.5
(5.3)
|
30.9
(5.5)
|
31.1
(5.3)
|
29.9
(2.8)
|
31.6
(5.2)
|
32.8
(5.4)
|
31.4
(5.2)
|
| Systolic blood pressure (mmHg) (mmHg) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [mmHg] |
96.6
(9.2)
|
96.4
(14.5)
|
95.2
(9.6)
|
96.1
(11.8)
|
97.3
(11.7)
|
94.4
(14.1)
|
96.4
(10.1)
|
| Diastolic blood pressure (mmHg) (mmHg) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [mmHg] |
55.8
(11.0)
|
54.5
(11.5)
|
51.3
(7.5)
|
53.3
(10.1)
|
53.5
(10.2)
|
52.0
(8.0)
|
53.5
(9.7)
|
| Height (cm) (cm) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [cm] |
84.7
(7.0)
|
84.3
(6.7)
|
84.8
(9.0)
|
85.7
(9.2)
|
83.1
(6.9)
|
81.2
(8.3)
|
84.2
(7.6)
|
| Weight (kg) (kg) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [kg] |
12.23
(1.97)
|
11.97
(2.10)
|
12.04
(2.52)
|
12.51
(3.11)
|
11.73
(1.93)
|
11.04
(2.17)
|
12.00
(2.14)
|
Outcome Measures
| Title | Occurrence of Solicited Symptoms During a 8 Day Follow-up Period After Each Vaccination |
|---|---|
| Description | Occurrence of any, local, or general solicited symptoms during the 8 day follow-up period |
| Time Frame | 40 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A Malaria Vaccine | Imovax Rabies Vaccine | Overall |
|---|---|---|---|
| Arm/Group Description | Subject vaccinated with FMP1/AS02A (cohorts A, B, and C) | Subject vaccinated with Imovax Rabies Vaccine (cohorts A, B, and C) | Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine (cohorts A, B, and C) |
| Measure Participants | 90 | 45 | 135 |
| Cohort A: Any Imm - Any Symptom |
24
|
11
|
35
|
| Cohort A: Any Imm - Local |
15
|
2
|
17
|
| Cohort A: Any Imm - General |
18
|
10
|
29
|
| Cohort A: Imm 1 - Any Symptom |
16
|
7
|
23
|
| Cohort A: Imm 1 - Local |
9
|
0
|
9
|
| Cohort A: Imm 1 - General |
11
|
7
|
18
|
| Cohort A: Imm 2 - Any Symptom |
13
|
6
|
19
|
| Cohort A: Imm 2 - Local |
5
|
2
|
7
|
| Cohort A: Imm 2 - General |
10
|
4
|
14
|
| Cohort A: Imm 3 - Any Symptom |
4
|
2
|
6
|
| Cohort A: Imm 3 - Local |
1
|
0
|
1
|
| Cohort A: Imm 3 - General |
4
|
2
|
6
|
| Cohort B: Any Imm - Any Symptom |
28
|
10
|
38
|
| Cohort B: Any Imm - Local |
24
|
1
|
25
|
| Cohort B: Any Imm - General |
18
|
10
|
28
|
| Cohort B: Imm 1 - Any Symptom |
21
|
6
|
27
|
| Cohort B: Imm 1 - Local |
14
|
0
|
14
|
| Cohort B: Imm 1 - General |
12
|
6
|
18
|
| Cohort B: Imm 2 - Any Symptom |
15
|
5
|
20
|
| Cohort B: Imm 2 - Local |
12
|
1
|
13
|
| Cohort B: Imm 2 - General |
8
|
5
|
13
|
| Cohort B: Imm 3 - Any Symptom |
15
|
4
|
19
|
| Cohort B: Imm 3 - Local |
11
|
0
|
11
|
| Cohort B: Imm 3 - General |
7
|
4
|
11
|
| Cohort C: Any Imm - Any Symptom |
28
|
8
|
36
|
| Cohort C: Any Imm - Local |
26
|
2
|
28
|
| Cohort C: Any Imm - General |
20
|
6
|
26
|
| Cohort C: Imm 1 - Any Symptom |
24
|
4
|
28
|
| Cohort C: Imm 1 - Local |
18
|
1
|
19
|
| Cohort C: Imm 1 - General |
15
|
3
|
18
|
| Cohort C: Imm 2 - Any Symptom |
19
|
4
|
23
|
| Cohort C: Imm 2 - Local |
17
|
1
|
18
|
| Cohort C: Imm 2 - General |
10
|
3
|
13
|
| Cohort C: Imm 3 - Any Symptom |
22
|
2
|
24
|
| Cohort C: Imm 3 - Local |
19
|
0
|
19
|
| Cohort C: Imm 3 - General |
10
|
2
|
12
|
| Title | Occurrence of Unsolicited Symptoms During a 30 Day Follow-up Period After Each Vaccination |
|---|---|
| Description | Occurrence of unsolicited symptoms during a 30 day follow-up period after each vaccination (day of vaccination and the 29 subsequent days) |
| Time Frame | 90 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A Imm 1 | FMP1/AS02A Imm 2 | FMP1/AS02A Imm 3 | FMP1/AS02A Any Imm | Imovax Imm 1 | Imovax Imm 2 | Imovax Imm 3 | Imovax Any Imm |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Subjects 1st vaccination with FMP1/AS02A | Subjects 2nd vaccination with FMP1/AS02A | Subjects 3rd vaccination with FMP1/AS02A | Subjects vaccinated within all immunization cycles | Subjects 1st vaccination with Imovax Rabies Vaccine | Subjects 2nd vaccination with Imovax Rabies Vaccine | Subjects 3rd vaccination with Imovax Rabies Vaccine | Subjects vaccinated within all immunization cycles |
| Measure Participants | 30 | 30 | 28 | 88 | 15 | 14 | 13 | 42 |
| Cohort A: Parasitic Infection |
19
|
15
|
13
|
27
|
9
|
5
|
8
|
13
|
| Cohort A: Resistance Mechanism |
13
|
18
|
14
|
28
|
5
|
7
|
4
|
10
|
| Cohort A: Skin and appendages |
7
|
14
|
11
|
20
|
8
|
5
|
4
|
11
|
| Cohort A: Respiratory System |
10
|
8
|
4
|
18
|
5
|
7
|
2
|
11
|
| Cohort A: Gastrointestinal System |
7
|
9
|
4
|
17
|
0
|
3
|
6
|
7
|
| Cohort A: Body as a Whole: General |
5
|
6
|
2
|
10
|
2
|
2
|
1
|
4
|
| Cohort A: Vision |
0
|
4
|
2
|
6
|
2
|
1
|
1
|
4
|
| Cohort A: Red Blood Cells |
1
|
1
|
2
|
4
|
0
|
0
|
0
|
0
|
| Cohort A: Unclassified |
0
|
1
|
1
|
2
|
1
|
0
|
0
|
1
|
| Cohort A: Application Site |
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
| Cohort A: Urinary System |
1
|
0
|
1
|
2
|
0
|
0
|
0
|
0
|
| Cohort B: Resistance Mechnism |
14
|
15
|
13
|
24
|
7
|
11
|
7
|
15
|
| Cohort B: Parasitic Infection |
14
|
14
|
12
|
25
|
9
|
7
|
6
|
13
|
| Cohort B: Skin and Appedages |
11
|
13
|
5
|
20
|
5
|
5
|
4
|
8
|
| Cohort B: Respiratory System |
11
|
13
|
5
|
20
|
5
|
5
|
4
|
8
|
| Cohort B: Gastrointestinal System |
6
|
6
|
5
|
13
|
2
|
1
|
3
|
6
|
| Cohort B: Body as a Whole: General |
8
|
4
|
3
|
12
|
1
|
1
|
3
|
4
|
| Cohort B: Vision |
1
|
7
|
4
|
11
|
2
|
2
|
1
|
5
|
| Cohort B: Liver and Biliary System |
1
|
0
|
3
|
4
|
1
|
1
|
0
|
2
|
| Cohort B: Unclassified |
1
|
0
|
2
|
3
|
2
|
0
|
1
|
3
|
| Cohort B: Musculoskeletal System |
1
|
1
|
1
|
3
|
0
|
0
|
0
|
0
|
| Cohort B: Red Blood Cells |
0
|
0
|
0
|
0
|
0
|
2
|
0
|
2
|
| Cohort B: Central and Peripheral Nervous |
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
| Cohort B: Hearing and Vestibular |
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
| Cohort B: Urinary System |
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
| Cohort C: Resistance Mechanism |
18
|
18
|
10
|
25
|
8
|
7
|
8
|
13
|
| Cohort C: Parasitic Infection |
14
|
11
|
8
|
17
|
10
|
10
|
7
|
13
|
| Cohort C: Skin and Appendages |
9
|
12
|
2
|
17
|
5
|
4
|
4
|
10
|
| Cohort C: Respiratory System |
10
|
1
|
4
|
12
|
7
|
3
|
3
|
10
|
| Cohort C: Gastrointestinal System |
2
|
8
|
5
|
12
|
3
|
2
|
5
|
8
|
| Cohort C: Body as a Whole: General |
4
|
4
|
3
|
10
|
1
|
1
|
2
|
3
|
| Cohort C: Vision |
7
|
1
|
1
|
8
|
2
|
2
|
0
|
4
|
| Cohort C: Unclassified |
1
|
2
|
3
|
6
|
1
|
0
|
1
|
2
|
| Cohort C: Hearing and Vestibular |
0
|
1
|
0
|
1
|
0
|
0
|
1
|
1
|
| Cohort C: Red Blood Cells |
0
|
1
|
0
|
1
|
1
|
0
|
0
|
1
|
| Cohort C: Central and Peripheral Nervous |
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
| Cohort C: Liver and Biliary System |
0
|
1
|
0
|
1
|
0
|
0
|
0
|
0
|
| Cohort C: Urinary System |
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
| Title | Occurrence of Serious Adverse Events During an 8 Month Follow-up Period Following the First Dose of Study Vaccine |
|---|---|
| Description | Occurrence of solicited and unsolicited serious adverse events during an 8 month follow-up period following the first dose of study vaccine |
| Time Frame | 8 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A Malaria Vaccine | Imovax Rabies Vaccine | Overall |
|---|---|---|---|
| Arm/Group Description | Subject vaccinated with FMP1/AS02A | Subject vaccinated with Imovax Rabies Vaccine | Subjects vaccinated with FMP1/AS02A and Imovax Rabies Vaccine |
| Measure Participants | 89 | 45 | 134 |
| Cohort A: Any SAE |
2
|
1
|
3
|
| Cohort A: Imm 1 |
0
|
0
|
0
|
| Cohort A: Imm 2 |
1
|
0
|
1
|
| Cohort A: Imm 3 |
1
|
1
|
2
|
| Cohort B: Any SAE |
0
|
0
|
0
|
| Cohort B: Imm 1 |
0
|
0
|
0
|
| Cohort B: Imm 2 |
0
|
0
|
0
|
| Cohort B: Imm 3 |
0
|
0
|
0
|
| Cohort C: Any SAE |
1
|
0
|
1
|
| Cohort C: Imm 1 |
0
|
0
|
0
|
| Cohort C: Imm 2 |
1
|
0
|
1
|
| Cohort C: Imm 3 |
0
|
0
|
0
|
| Title | Anti-FMP1 Antibody Titer Responses |
|---|---|
| Description | Antibody responses to FMP1 by ELISA following immunization with the study vaccine through 364 days following the first dose of study vaccine |
| Time Frame | 364 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A Malaria Vaccine 10ug (Cohort A) | Imovax (Cohort A) | FMP1/AS02A Malaria Vaccine 25 ug (Cohort B) | Imovax (Cohort B) | FMP1/AS02A Malaria Vaccine 50 ug (Cohort C) | Imovax (Cohort C) |
|---|---|---|---|---|---|---|
| Arm/Group Description | Subject vaccinated with 10 ug of FMP1/AS02A on days 0, 29 and 57 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | Subject vaccinated with 25 ug of FMP1/AS02A on days 14, 42, and 70 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days | Subject vaccinated with 50 ug of FMP1/AS02A on days 28, 56 and 84 FMP1/AS02A Malaria vaccine: Subjects vaccinated with FMP1/AS02 vaccine | Subject vaccinated with Imovax Rabies Vaccine on corresponding FMP1/AS021 vaccination days Imovax Rabies vaccine: Subjects vaccinated on corresponding FMP1/AS02A vaccination days |
| Measure Participants | 29 | 15 | 30 | 15 | 30 | 15 |
| Pre-Imm 1 |
2141
|
2814
|
2737
|
3226
|
2301
|
1041
|
| Day 14 |
2711
|
2857
|
4784
|
2520
|
5729
|
944
|
| Pre-Imm 2 |
2440
|
2829
|
2777
|
4282
|
4705
|
1041
|
| Day 44 |
4438
|
2562
|
8390
|
3593
|
10791
|
1105
|
| Pre-Imm 3 |
4534
|
2013
|
10240
|
2258
|
10631
|
1034
|
| Day 74 |
10151
|
1529
|
43399
|
3368
|
50166
|
790
|
| Day 90 |
10332
|
1768
|
27189
|
2909
|
34657
|
1039
|
| Day 180 |
5354
|
1788
|
13496
|
4318
|
14840
|
999
|
| Day 270 |
6190
|
1877
|
14839
|
6020
|
15380
|
1970
|
| Day 364 |
4115
|
2238
|
12043
|
4005
|
8807
|
1295
|
Adverse Events
| Time Frame | 240 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The numbers of participants experiencing each specific event is not known, only the number of occurrences of each event. Therefore, individual occurrences are listed separately in the tables | |||
| Arm/Group Title | FMP1/AS02A Malaria Vaccine | Imovax | ||
| Arm/Group Description | Subject vaccinated with FMP1/AS02A | Subject vaccinated with Imovax Rabies Vaccine | ||
All Cause Mortality |
||||
| FMP1/AS02A Malaria Vaccine | Imovax | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/90 (1.1%) | 0/45 (0%) | ||
Serious Adverse Events |
||||
| FMP1/AS02A Malaria Vaccine | Imovax | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/90 (3.3%) | 2/45 (4.4%) | ||
| Gastrointestinal disorders | ||||
| Intestinal obstruction | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| General disorders | ||||
| Anemia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Nervous system disorders | ||||
| Convulsions | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Convulsions | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Convulstions | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Convulsions | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Bronchospasm | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| FMP1/AS02A Malaria Vaccine | Imovax | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 87/90 (96.7%) | 10/45 (22.2%) | ||
| Blood and lymphatic system disorders | ||||
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Anemia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Anemia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Marlaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Anemia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Anemia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Marlaria | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Anemia | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Malaria | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Anemia | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Ear and labyrinth disorders | ||||
| Otitis externa | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis externa | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Earache | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis externa | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Otitis exrterna | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Otitis externa | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Earache | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Eye disorders | ||||
| Eye pain | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gingivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Oral candidiasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Foriegn body in throat | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Enterobiasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Stomatitis ulcerative | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Abdominal pain | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Nausea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loose stool | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Vomiting | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Stomatitis ulceratived | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rectal disorder | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loose stool | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| History of fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Diarrhea | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Toothache | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Toothache | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Abdominal pain | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gastroenteritis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Diarrhea | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Diarrhea | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Vomiting | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Anal fissure | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pruritus | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Stomatitis ulcerative | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Diarrhea | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Diarrhea | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loose stool | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Gastroenteritis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Vomiting | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Constipation | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Abdominal pain | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Diarrhea | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Gastroenteritis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Constipation | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Abdominal discomfort | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| General disorders | ||||
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Irritability | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Irritability | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Irritability | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Irritability | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Irritability | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Irritability | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Poor feeding | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| History of fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| History of fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Poor feeding | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| History of fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Poor feeding | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Poor feeding | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Gluteal ulcer | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Poor feeding | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| History of fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Fever | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| History of fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Poor feeding | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Poor feeding | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| History of fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Poor feeding | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| History of fever | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Poor feeding | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Hepatobiliary disorders | ||||
| Hepatitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Infections and infestations | ||||
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Cellulitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis media | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis media | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea corporis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Moniliasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Moniliasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pneumonia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Herpes simplex | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivtis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Moniliasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Cellulitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Moniliasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea capitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Helminthiasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Helminthiasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea corporis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjuctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis media | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis media | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Abscess | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Herpes simplex | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Helminthiasis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea corporis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Cellulitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea capitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Otitis media | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea capitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Folliculitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Cellulitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Tinea corporis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Cellulitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Helminthiasis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pneumonia | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Tinea capitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjuntivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pruritis ani | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Gingivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Tinea capitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Tinea corporis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Conjunctivitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Folliculitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| tinea corporis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Monilliasis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Septic wound | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Helminthiasis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at the injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injections site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at the injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at the injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at the injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Swelling at injection site | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pain at injection site | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pain at injection site | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pain at injection site | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pain at injection site | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Superficial burn | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injection site induration | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Conjunctivitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Septic wound secondary to trauma | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Injury | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Superficial burn | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Injection site hyperpigmentation | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Injury | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Injury | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Injury | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Investigations | ||||
| SBPT increased | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| SGPT increased | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| SGPT increased | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| SGPT increased | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| SGPT increased | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Metabolism and nutrition disorders | ||||
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetate | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Dehydration | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Loss of appetite | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Myalgia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Myalgia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Headache | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Headache | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Renal and urinary disorders | ||||
| Micturition disorder | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Urinary tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Urinary tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Micturition disorder | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Urinary tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Urinary tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Reproductive system and breast disorders | ||||
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pneumonia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Laryngitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Foriegn body in nostril | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Pneumonia | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rhinitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Lower respiratory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper resporatory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respriatory tract infection | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Coughing | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respitratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Pharyngitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respitratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coryza | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respiratory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Upper respriatory tract infection | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Coughing | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rhinitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Laryngitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Epistaxis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Bronchospasm | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Eczema | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Eczema | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Small plaques | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Furunculosis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash erythematous | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea corporis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Tinea corporis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Dermatitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Septic lesion left pinna | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Dermatitis | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Rash pustular | 1/90 (1.1%) | 1 | 0/45 (0%) | 0 |
| Dermatitis | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Eczema | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Eczema | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Skin disorder | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
| Rash pustular | 0/90 (0%) | 0 | 1/45 (2.2%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
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 | Mark A. Withers, MD PhD |
|---|---|
| Organization | USAMRU-K |
| Phone | +254-722-449-357 |
| aodika@wrp-ksm.org |
Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT00317473
Other Study ID Numbers:
- WRAIR 1030
- HSRRB Log No. A-12094
- KEMRI SSC No. 761
- HSPC No. HS171
First Posted:
Apr 24, 2006
Last Update Posted:
Oct 2, 2017
Last Verified:
May 1, 2017