Double-blind, Randomized, Controlled Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine
Sponsor
U.S. Army Medical Research and Development Command (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00223990
Collaborator
The PATH Malaria Vaccine Initiative (MVI) (Other), United States Agency for International Development (USAID) (U.S. Fed), GlaxoSmithKline (Industry), Kenya Medical Research Institute (Other), Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)
400
1
2
25.8
15.5
Study Details
Study Description
Brief Summary
This trial is currently evaluating one candidate malaria vaccine, FMP1/AS02A. This candidate malaria vaccine is being developed for the routine immunization of infants and children living in malaria-endemic areas. This vaccine would offer protection against malaria disease due to the parasite Plasmodium falciparum.
Prior to the start of this study, FMP1/AS02A had been given to approximately 60 malaria-naïve adults and 40 adults and 90 children living in malaria-endemic regions.
This study will investigate whether the candidate vaccine prevents malaria disease for 6 months post-vaccination.
One half of the enrolled subjects will receive FMP1/AS02A and the other half rabies vaccine (RabAvert).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Field trial of a candidate antigen/adjuvant conducted at one study center with 12 outlying (satellite) field stations. Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine). The planned immunization schedule was 0, 1, and 2 months for both study arms; however, the 4-week intervals between doses could be extended for up to 2 additional weeks if temporary suspension was deemed advisable due to serious adverse events (SAEs) or other concerns. Vaccinations were administered intramuscularly (IM) in the left anterolateral thigh muscle unless a compelling reason for using an alternate injection site was evident. Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration. Active case detection occurred during the Efficacy Follow-up Period (169 days, starting 14 days after the third vaccination (Day 71)), active case detection commenced with visits approximately every 28 days to the Walter Reed Project Kombewa clinic and terminated after 6 months (approximately Day 240). The primary study analysis for all endpoints was completed on the cleaned Efficacy Follow-up Period database after a data-lock-point. The Addendum Efficacy Follow-up Period (125 days) started with the end of the Efficacy Follow-up Period (approximately Day 240) and active case detection commenced with visits approximately every 28 days to the Walter Reed Project Kombewa Clinic and terminated after 10 months (approximately Day 364). The study addendum analysis for all endpoints was completed after the Addendum Efficacy Follow-up Period database after a data-lock-point.
Malaria cases were detected actively and passively. Active case detection was handled through scheduled (1) facilitated participant visits to the Kombewa Clinic and (2) field worker visits to participant homes. Passive case detection was handled through unscheduled, self-presentation of participants to the Kombewa Clinic. At scheduled clinic visits, blood samples were taken from all subjects to determine parasite density and hemoglobin levels. At home visits, subjects with fever or other illness within the 24 hours were transported to the clinic for collection of blood samples.
Study Design
Study Type:
Interventional
Actual Enrollment
:
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine (RabAvert)).Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine (RabAvert)).
Masking:
Double (Participant, Investigator)
Masking Description:
Both study participants and those investigators responsible for evaluation of the endpoints will be blinded as to who receives the test article versus the comparator. On vaccination days, the comparator vaccine will be in the same package as received from the manufacturer. After agitation it will appear clear and pink. The FMP1 antigen and the AS02A adjuvant will be packaged separately. The reconstituted FMPI antigen in the AS02A adjuvant/diluent will have a milky white appearance. Because the vaccines will have a markedly different appearance, contents of the syringe will be concealed as described later in this section. The two vaccine preparation teams, consisting of the study pharmacist, pharmacy assistants, and drug manager (an experienced nurse, clinician, or pharmacist), will be responsible for vaccine preparation. They will also verify that the proper vaccine and vaccine dose is prepared and delivered to each subject.
Primary Purpose:
Prevention
Official Title:
A Dbl-blind,Randomized,Controlled,Phase IIb Field Trial in 12-47 Month-old Children in Western Kenya to Eval the Efficacy,Safety and Immunogenicity of the FMP1/AS02A Malaria Vaccine vs Rabies Vaccine
Actual Study Start Date
:
Apr 8, 2005
Actual Primary Completion Date
:
Apr 26, 2006
Actual Study Completion Date
:
Jun 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FMP1/AS02A FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months |
Biological: FMP1/AS02A
FMP1/AS02A candidate malaria vaccine
|
| Active Comparator: RabAvert (rabies vaccine) RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months |
Biological: RabAvert
RabAvert rabies vaccine
|
Outcome Measures
Primary Outcome Measures
- Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population [starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240]
Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ITT population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = >37.5°C with presence of a density of asexual stage P. falciparum >50K parasites/µL blood Secondary (200) = >37.5°C with presence of a density of asexual stage P. falciparum >200K parasites/µL blood Secondary (100) = >37.5°C with presence of a density of asexual stage P. falciparum >100K parasites/µL blood Secondary (10) = >37.5°C with presence of a density of asexual stage P. falciparum >10K parasites/µL blood Secondary (0) = >37.5°C with presence of a density of asexual stage P. falciparum >0 parasites/µL blood Secondary (0*) = >37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum >0 parasites/µL blood
Secondary Outcome Measures
- Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population [starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240]
Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ATP population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = >37.5°C with presence of a density of asexual stage P. falciparum >50K parasites/µL blood Secondary (200) = >37.5°C with presence of a density of asexual stage P. falciparum >200K parasites/µL blood Secondary (100) = >37.5°C with presence of a density of asexual stage P. falciparum >100K parasites/µL blood Secondary (10) = >37.5°C with presence of a density of asexual stage P. falciparum >10K parasites/µL blood Secondary (0) = >37.5°C with presence of a density of asexual stage P. falciparum >0 parasites/µL blood Secondary (0*) = >37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum >0 parasites/µL blood
- Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population [vaccination day plus post-vaccination days 1, 2, 3, and 6]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
- Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population [vaccination day plus post-vaccination days 1, 2, 3, and 6]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
- Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population [vaccination day and 29 subsequent days]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
- Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population [vaccination day and 29 subsequent days]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
- Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization [vaccination day plus post-vaccine days 1, 2, 3, and 6; 30 day follow-up for unsolicited events and follow-up for SAEs to continue for duration of study (364 days)]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration (364 days)
- Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) [vaccination day plus 29 subsequent days]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
- Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) [vaccination day plus 29 subsequent days]
Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Months
to 47 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
-
A healthy male or female child, 12 to 47 months of age on the day of screening
-
Written informed consent obtained from at least one parent/guardian before study start
-
Available to participate for the study duration (about 14 months)
Exclusion Criteria:
-
Acute disease at the time of entry into the study that in the opinion of the investigator may pose a threat to the subject
-
Prior receipt of a rabies vaccine or any investigational 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 corticosteroids, 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/AS02A)
-
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. (No HIV test will be performed as part of this study.)
-
History of allergic reactions or anaphylaxis to immunizations or to any vaccine components, such as eggs
-
History of surgical splenectomy
-
Administration of immunoglobulins, blood transfusions, or any other blood products within the six 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 that 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 | Kisumu | Nyanza Province | Kenya |
Sponsors and Collaborators
- U.S. Army Medical Research and Development Command
- The PATH Malaria Vaccine Initiative (MVI)
- United States Agency for International Development (USAID)
- GlaxoSmithKline
- Kenya Medical Research Institute
- Walter Reed Army Institute of Research (WRAIR)
Investigators
- Principal Investigator: Bernhards Ogutu, M.D., Kenya Medical Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Angov E, Aufiero BM, Turgeon AM, Van Handenhove M, Ockenhouse CF, Kester KE, Walsh DS, McBride JS, Dubois MC, Cohen J, Haynes JD, Eckels KH, Heppner DG, Ballou WR, Diggs CL, Lyon JA. Development and pre-clinical analysis of a Plasmodium falciparum Merozoite Surface Protein-1(42) malaria vaccine. Mol Biochem Parasitol. 2003 May;128(2):195-204.
- 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.
Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT00223990
Other Study ID Numbers:
- A-13228
- IND 9202
- 1123
First Posted:
Sep 22, 2005
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021
Keywords provided by U.S. Army Medical Research and Development Command
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Subjects were screened no more than 45 days prior to the first inoculation and were randomized on the first day of vaccination 1:1 between two arms (FMP1/AS02A and rabies vaccine) at the Walter Reed Project Kombewa Clinic in Kombewa Division, Kisumu District, Nyanze Province, Western Kenya (and 12 small field stations within Kombewa Division). |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Period Title: Overall Study | ||
| STARTED | 200 | 200 |
| COMPLETED | 193 | 191 |
| NOT COMPLETED | 7 | 9 |
Baseline Characteristics
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) | Total |
|---|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine | Total of all reporting groups |
| Overall Participants | 200 | 200 | 400 |
| Age (Months) [Mean (Standard Deviation) ] | |||
| Walter Reed Project Field Station |
28.6
(10.6)
|
29.2
(10.9)
|
28.9
(10.7)
|
| Abol Field Station |
34.3
(9.7)
|
28.9
(10.0)
|
31.6
(10.0)
|
| Bar-Korwa Field Station |
22.0
(6.2)
|
32.8
(5.9)
|
26.6
(8.0)
|
| Got-Aglu Field Station |
29.1
(11.8)
|
25.0
(8.6)
|
26.8
(10.2)
|
| Kitare Field Station |
30.2
(10.7)
|
29.9
(10.0)
|
30.1
(10.2)
|
| Kuoyo-Kowe Field Station |
31.1
(9.3)
|
31.7
(9.4)
|
31.4
(9.2)
|
| Manyanda Field Station |
30.6
(6.4)
|
31.1
(8.2)
|
30.9
(7.0)
|
| Mirieri Field Station |
30.3
(10.0)
|
26.5
(10.1)
|
28.8
(10.0)
|
| Nduru Field Station |
26.1
(10.2)
|
34.6
(10.2)
|
30.9
(10.9)
|
| Oruga Field Station |
30.5
(9.5)
|
33.1
(9.6)
|
31.8
(9.5)
|
| Osewre Field Station |
31.1
(11.3)
|
30.7
(8.4)
|
30.9
(9.8)
|
| Ranen Field Station |
26.2
(10.9)
|
32.2
(11.2)
|
29.5
(11.2)
|
| Reru Field Station |
26.9
(11.0)
|
30.3
(10.8)
|
28.9
(10.7)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
8%
|
17
8.5%
|
33
8.3%
|
| Male |
25
12.5%
|
24
12%
|
49
12.3%
|
| Female |
7
3.5%
|
4
2%
|
11
2.8%
|
| Male |
7
3.5%
|
8
4%
|
15
3.8%
|
| Female |
3
1.5%
|
3
1.5%
|
6
1.5%
|
| Male |
4
2%
|
2
1%
|
6
1.5%
|
| Female |
6
3%
|
6
3%
|
12
3%
|
| Male |
8
4%
|
11
5.5%
|
19
4.8%
|
| Female |
10
5%
|
5
2.5%
|
15
3.8%
|
| Male |
9
4.5%
|
12
6%
|
21
5.3%
|
| Female |
8
4%
|
7
3.5%
|
15
3.8%
|
| Male |
9
4.5%
|
11
5.5%
|
20
5%
|
| Female |
5
2.5%
|
5
2.5%
|
10
2.5%
|
| Male |
3
1.5%
|
2
1%
|
5
1.3%
|
| Female |
13
6.5%
|
3
1.5%
|
16
4%
|
| Male |
5
2.5%
|
8
4%
|
13
3.3%
|
| Female |
8
4%
|
5
2.5%
|
13
3.3%
|
| Male |
2
1%
|
8
4%
|
10
2.5%
|
| Female |
7
3.5%
|
7
3.5%
|
14
3.5%
|
| Male |
12
6%
|
11
5.5%
|
23
5.8%
|
| Female |
3
1.5%
|
6
3%
|
9
2.3%
|
| Male |
8
4%
|
3
1.5%
|
11
2.8%
|
| Female |
6
3%
|
5
2.5%
|
11
2.8%
|
| Male |
4
2%
|
7
3.5%
|
11
2.8%
|
| Female |
5
2.5%
|
5
2.5%
|
10
2.5%
|
| Male |
2
1%
|
5
2.5%
|
7
1.8%
|
| Race and Ethnicity Not Collected (Count of Participants) | |||
| Count of Participants [Participants] |
0
0%
|
||
| Region of Enrollment (Count of Participants) | |||
| Kenya |
200
100%
|
200
100%
|
400
100%
|
| Malaria Prevention - WRAIR Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
34
17%
|
31
15.5%
|
65
16.3%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
6
3%
|
7
3.5%
|
13
3.3%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin, g/dL - WRAIR Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
1.16
(1.377)
|
10.53
(1.18)
|
10.40
(1.29)
|
| Sickle Cell Status - WRAIR Field Station (Count of Participants) | |||
| AA |
37
18.5%
|
36
18%
|
73
18.3%
|
| AS |
3
1.5%
|
5
2.5%
|
8
2%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
1
0.5%
|
0
0%
|
1
0.3%
|
| G6PD deficient |
4
2%
|
6
3%
|
10
2.5%
|
| Alpha-Thalassemia - WRAIR Field Station (Count of Participants) | |||
| Hetero |
17
8.5%
|
20
10%
|
37
9.3%
|
| Normal |
21
10.5%
|
20
10%
|
41
10.3%
|
| Homo |
3
1.5%
|
1
0.5%
|
4
1%
|
| Parasite Density (par/µL blood) - WRAIR Field Station (par/µL blood) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL blood] |
5045.3
(13280.0)
|
5716.3
(24832.9)
|
5380.8
(19792.3)
|
| Malaria Prevention - Abol Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
11
5.5%
|
11
5.5%
|
22
5.5%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Hemoglobin, g/dL - Abol Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.69
(0.70)
|
9.99
(1.13)
|
10.37
(0.98)
|
| Sickle Cell Status - Abol Field Station (Count of Participants) | |||
| AA |
12
6%
|
7
3.5%
|
19
4.8%
|
| AS |
2
1%
|
4
2%
|
6
1.5%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
1
0.5%
|
1
0.3%
|
| G6PD deficient |
0
0%
|
1
0.5%
|
1
0.3%
|
| Baseline Alpha-Thalassemia - Abol Field Station (Count of Participants) | |||
| Hetero |
6
3%
|
3
1.5%
|
9
2.3%
|
| Normal |
7
3.5%
|
8
4%
|
15
3.8%
|
| Homo |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Baseline Density (par-µL blood)- Abol Field Station (par/µL blood) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL blood] |
1509.6
(2816.8)
|
303.5
(754.7)
|
963.0
(2180.0)
|
| Baseline Malaria Prevention - Bar-Korwa Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
7
3.5%
|
5
2.5%
|
12
3%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use moquito coils or sprays |
0
0%
|
1
0.5%
|
1
0.3%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Bar-Korwa Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.24
(0.91)
|
10.28
(0.84)
|
10.26
(0.84)
|
| Baseline Sickle Cell Status - Bar-Korwa Field Station (Count of Participants) | |||
| AA |
3
1.5%
|
4
2%
|
7
1.8%
|
| AS |
4
2%
|
1
0.5%
|
5
1.3%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
0
0%
|
1
0.5%
|
1
0.3%
|
| Baseline Alpha-Thalassemia- Bar-Korwa Field Station (Count of Participants) | |||
| Hetero |
0
0%
|
2
1%
|
2
0.5%
|
| Normal |
6
3%
|
3
1.5%
|
9
2.3%
|
| Homo |
1
0.5%
|
0
0%
|
1
0.3%
|
| Baseline Parasite Density (par/µL blood) - Bar-Korwa Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
1481.1
(3918.5)
|
1679.0
(2907.7)
|
1563.5
(3385.3)
|
| Baseline Malaria Prevention - Got-Aglu Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
8
4%
|
8
4%
|
16
4%
|
| Use topical mosquito repellents |
1
0.5%
|
0
0%
|
1
0.3%
|
| Use mosquito coils or sprays |
4
2%
|
7
3.5%
|
11
2.8%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Got-Aglu Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.42
(1.36)
|
10.30
(1.38)
|
10.35
(1.35)
|
| Baseline Sickle Cell Status - Got-Aglu Field Station (Count of Participants) | |||
| AA |
8
4%
|
14
7%
|
22
5.5%
|
| AS |
5
2.5%
|
3
1.5%
|
8
2%
|
| AD |
1
0.5%
|
0
0%
|
1
0.3%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
2
1%
|
3
1.5%
|
5
1.3%
|
| Baseline Alpha-Thalassemia - Got-Aglu Field Station (Count of Participants) | |||
| Hetero |
9
4.5%
|
10
5%
|
19
4.8%
|
| Normal |
4
2%
|
6
3%
|
10
2.5%
|
| Homo |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Baseline Parasite Density (par/µL blood) - Got-Aglu Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
2427.1
(6899.7)
|
3932.5
(7509.3)
|
3252.7
(7161.3)
|
| Baseline Malarie Prevention - Kitare Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
17
8.5%
|
16
8%
|
33
8.3%
|
| Use topical mosquito repellents |
1
0.5%
|
0
0%
|
1
0.3%
|
| Use mosquito coils or sprays |
0
0%
|
1
0.5%
|
1
0.3%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Kitare Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.42
(1.10)
|
9.96
(0.94)
|
10.20
(1.04)
|
| Baseline Sickle Cell Status - Kitare Field Station (Count of Participants) | |||
| AA |
14
7%
|
10
5%
|
24
6%
|
| AS |
5
2.5%
|
7
3.5%
|
12
3%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
1
0.5%
|
2
1%
|
3
0.8%
|
| Baseline Alpha-Thalassemia - Kitare Field Station (Count of Participants) | |||
| Hetero |
9
4.5%
|
10
5%
|
19
4.8%
|
| Normal |
7
3.5%
|
6
3%
|
13
3.3%
|
| Homo |
3
1.5%
|
1
0.5%
|
4
1%
|
| Baseline Parasite Density (par/µL blood) - Kitare Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
1645.5
(4375.6)
|
550.1
(1416.7)
|
1144.8
(3355.7)
|
| Baseline Malaria Prevention - Kuoyo-Kowe Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
9
4.5%
|
12
6%
|
21
5.3%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
3
1.5%
|
4
2%
|
7
1.8%
|
| Other |
1
0.5%
|
0
0%
|
1
0.3%
|
| Baseline Hemoglobin (g/dL) - Kuoyo-Kowe Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.75
(1.20)
|
10.19
(1.28)
|
10.46
(1.25)
|
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station (Count of Participants) | |||
| AA |
13
6.5%
|
16
8%
|
29
7.3%
|
| AS |
4
2%
|
2
1%
|
6
1.5%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
5
2.5%
|
2
1%
|
7
1.8%
|
| Baseline Alpha-Thalassemia - Kuoyo-Kowe Field Station (Count of Participants) | |||
| Hetero |
3
1.5%
|
8
4%
|
11
2.8%
|
| Normal |
13
6.5%
|
7
3.5%
|
20
5%
|
| Homo |
1
0.5%
|
3
1.5%
|
4
1%
|
| Baseline Parasite Density (par/µL blood) - Kuoyo-Kowe Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
1073.0
(2664.)
|
1185.0
(4230.4)
|
1130.6
(3502.5)
|
| Baseline Malaria Prevention - Manyanda Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
7
3.5%
|
6
3%
|
13
3.3%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
2
1%
|
1
0.5%
|
3
0.8%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Manyanda Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.34
(1.29)
|
10.46
(7.67)
|
10.39
(1.42)
|
| Baseline Sick Cell Status - Manyanda Field Station (Count of Participants) | |||
| AA |
6
3%
|
4
2%
|
10
2.5%
|
| AS |
2
1%
|
3
1.5%
|
5
1.3%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
0
0%
|
0
0%
|
0
0%
|
| Baseline Alpha-Thalassemia - Manyanda Field Station (Count of Participants) | |||
| Hetero |
3
1.5%
|
1
0.5%
|
4
1%
|
| Normal |
5
2.5%
|
6
3%
|
11
2.8%
|
| Homo |
0
0%
|
0
0%
|
0
0%
|
| Baseline Parasite Density (par/µL blood) - Manyanda Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
148.9
(330.1)
|
2441.0
(4236.4)
|
1218.5
(3024.4)
|
| Baseline Malaria Prevention - Mirieri Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
10
5%
|
6
3%
|
16
4%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
1
0.5%
|
3
1.5%
|
4
1%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Mirieri Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
11.10
(0.97)
|
10.48
(1.38)
|
10.87
(1.16)
|
| Baseline Sickle Cell Status - Mirieri Field Station (Count of Participants) | |||
| AA |
16
8%
|
8
4%
|
24
6%
|
| AS |
2
1%
|
3
1.5%
|
5
1.3%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
3
1.5%
|
0
0%
|
3
0.8%
|
| Baseline Alpha-Thalassemia - Mirieri Field Station (Count of Participants) | |||
| Hetero |
8
4%
|
6
3%
|
14
3.5%
|
| Normal |
8
4%
|
4
2%
|
12
3%
|
| Homo |
2
1%
|
1
0.5%
|
3
0.8%
|
| Baseline Parasite Density (par/µL blood) - Mirieri Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
1669.4
(3848.2)
|
15775
(51756.8)
|
7019.6
(31662.4)
|
| Baseline Malaria Prevention - Nduru Kadero Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
5
2.5%
|
8
4%
|
13
3.3%
|
| Use topical mosquito repellents |
1
0.5%
|
0
0%
|
1
0.3%
|
| Use mosquito coils or sprays |
5
2.5%
|
2
1%
|
7
1.8%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Nduru Kadero Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.48
(1.18)
|
10.78
(1.28)
|
10.66
(1.21)
|
| Baseline Sickle Cell Status - Nduru Kadero Field Station (Count of Participants) | |||
| AA |
9
4.5%
|
11
5.5%
|
20
5%
|
| AS |
1
0.5%
|
2
1%
|
3
0.8%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
0
0%
|
1
0.5%
|
1
0.3%
|
| Baseline Alpha-Thalassemia - Nduru Kadero Field Station (Count of Participants) | |||
| Hetero |
5
2.5%
|
10
5%
|
15
3.8%
|
| Normal |
4
2%
|
2
1%
|
6
1.5%
|
| Homo |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Baseline Parasite Density (par/µL blood) - Nduru Kadero Field Station (par/µL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL] |
1676.5
(5123.2)
|
6749.7
(20674.1)
|
4543.9
(15826.8)
|
| Baseline Malaria Prevention - Oruga Field Station (Count of Participants) | |||
| Alwasy sleep under mosquito net |
15
7.5%
|
12
6%
|
27
6.8%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
1
0.5%
|
3
1.5%
|
4
1%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Oruga Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.57
(1.00)
|
9.96
(1.23)
|
10.27
(1.15)
|
| Baseline Sickle Cell Status - Oruga Field Station (Count of Participants) | |||
| AA |
15
7.5%
|
16
8%
|
31
7.8%
|
| AS |
3
1.5%
|
2
1%
|
5
1.3%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
1
0.5%
|
0
0%
|
1
0.3%
|
| G6PD deficient |
2
1%
|
2
1%
|
4
1%
|
| Baseline Alpha-Thalassemia - Oruga Field Station (Count of Participants) | |||
| Hetero |
4
2%
|
7
3.5%
|
11
2.8%
|
| Normal |
10
5%
|
9
4.5%
|
19
4.8%
|
| Homo |
5
2.5%
|
2
1%
|
7
1.8%
|
| Baseline Parasite Density (par/µL blood) - Oruga Field Station (par/µL blood) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL blood] |
1481.6
(3068.2)
|
3034.9
(5151.7)
|
2237.3
(4226.0)
|
| Baseline Malaria Prevention - Osewre Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
8
4%
|
6
3%
|
14
3.5%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
2
1%
|
1
0.5%
|
3
0.8%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Osewre Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.06
(1.62)
|
10.18
(1.08)
|
10.12
(1.37)
|
| Baseline Sickle Cell Status - Osewre Field Station (Count of Participants) | |||
| AA |
11
5.5%
|
9
4.5%
|
20
5%
|
| AS |
0
0%
|
0
0%
|
0
0%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
0
0%
|
2
1%
|
2
0.5%
|
| Baseline Alpha-Thalassemia - Osewre Field Station (Count of Participants) | |||
| Hetero |
3
1.5%
|
5
2.5%
|
8
2%
|
| Normal |
8
4%
|
3
1.5%
|
11
2.8%
|
| Homo |
0
0%
|
1
0.5%
|
1
0.3%
|
| Baseline Parasite Density (par/µL blood) - Osewre Field Station (par/µL blood) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL blood] |
5288.3
(10961.1)
|
1129.7
(2548.3)
|
3416.9
(8394.9)
|
| Baseline Malaria Prevention - Ranen Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
5
2.5%
|
12
6%
|
17
4.3%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
3
1.5%
|
0
0%
|
3
0.8%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Ranen Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.01
(1.03)
|
10.34
(1.24)
|
10.19
(1.14)
|
| Baseline Sickle Cell Status - Ranen Field Station (Count of Participants) | |||
| AA |
9
4.5%
|
9
4.5%
|
18
4.5%
|
| AS |
1
0.5%
|
3
1.5%
|
4
1%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Baseline Alpha-Thalassemia - Ranen Field Station (Count of Participants) | |||
| Hetero |
6
3%
|
5
2.5%
|
11
2.8%
|
| Normal |
2
1%
|
6
3%
|
8
2%
|
| Homo |
2
1%
|
1
0.5%
|
3
0.8%
|
| Baseline Parasite Density (par/µL blood) - Ranen Field Station (par/µL blood) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL blood] |
3734.0
(11675.1)
|
5906.4
(14161.9)
|
4871.9
(12761.4)
|
| Baseline Malaria Prevention - Reru Field Station (Count of Participants) | |||
| Always sleep under mosquito net |
3
1.5%
|
7
3.5%
|
10
2.5%
|
| Use topical mosquito repellents |
0
0%
|
0
0%
|
0
0%
|
| Use mosquito coils or sprays |
3
1.5%
|
5
2.5%
|
8
2%
|
| Other |
0
0%
|
0
0%
|
0
0%
|
| Baseline Hemoglobin (g/dL) - Reru Field Station (g/dL) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [g/dL] |
10.44
(1.57)
|
10.14
(1.03)
|
10.26
(1.24)
|
| Baseline Sickle Cell Status - Reru Field Station (Count of Participants) | |||
| AA |
5
2.5%
|
8
4%
|
13
3.3%
|
| AS |
2
1%
|
2
1%
|
4
1%
|
| AD |
0
0%
|
0
0%
|
0
0%
|
| A+ Hb Kenya |
0
0%
|
0
0%
|
0
0%
|
| G6PD deficient |
2
1%
|
2
1%
|
4
1%
|
| Baseline Alpha-Thalassemia - Reru Field Station (Count of Participants) | |||
| Hetero |
4
2%
|
5
2.5%
|
9
2.3%
|
| Normal |
2
1%
|
4
2%
|
6
1.5%
|
| Homo |
1
0.5%
|
1
0.5%
|
2
0.5%
|
| Baseline Parasite Density (par/µL blood) - Reru Field Station (par/µL blood) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [par/µL blood] |
823.5
(1490.1)
|
5377.5
(13315.9)
|
3502.3
(10291.2)
|
Outcome Measures
| Title | Subjects Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - Intent to Treat (ITT) Population |
|---|---|
| Description | Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ITT population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = >37.5°C with presence of a density of asexual stage P. falciparum >50K parasites/µL blood Secondary (200) = >37.5°C with presence of a density of asexual stage P. falciparum >200K parasites/µL blood Secondary (100) = >37.5°C with presence of a density of asexual stage P. falciparum >100K parasites/µL blood Secondary (10) = >37.5°C with presence of a density of asexual stage P. falciparum >10K parasites/µL blood Secondary (0) = >37.5°C with presence of a density of asexual stage P. falciparum >0 parasites/µL blood Secondary (0*) = >37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum >0 parasites/µL blood |
| Time Frame | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 200 | 200 |
| SA: Primary |
107
|
121
|
| SA: Secondary (200) |
25
|
29
|
| SA: Secondary (100) |
68
|
80
|
| SA: Secondary (10) |
130
|
143
|
| SA: Secondary (0) |
158
|
165
|
| SA: Secondary (0*) |
185
|
182
|
| MT: Primary |
105
|
116
|
| MT: Secondary (200) |
23
|
27
|
| MT: Secondary (100) |
64
|
76
|
| MT: Secondary (10) |
130
|
138
|
| MT: Secondary (0) |
156
|
161
|
| MT: Secondary (0*) |
186
|
182
|
| SA MT: Primary |
101
|
113
|
| SA MT: Secondary (200) |
22
|
27
|
| SA MT: Secondary (100) |
60
|
76
|
| SA MT: Secondary (10) |
125
|
138
|
| SA MT: Secondary (0) |
151
|
160
|
| SA MT: Secondary (0*) |
183
|
182
|
| Title | Time to First Clinical Episode of P Falciparum Malaria During the Efficacy Follow-up Period Adjusted for Time at Risk - According to Protocol (ATP) Population |
|---|---|
| Description | Days to first clinical episode of P falciparum malaria during the efficacy f/u period for ATP population Time at Risk adjusted for: SA= study absence MT= malaria treatment SA MT= study absence and malaria treatment Case Definitions: Primary = >37.5°C with presence of a density of asexual stage P. falciparum >50K parasites/µL blood Secondary (200) = >37.5°C with presence of a density of asexual stage P. falciparum >200K parasites/µL blood Secondary (100) = >37.5°C with presence of a density of asexual stage P. falciparum >100K parasites/µL blood Secondary (10) = >37.5°C with presence of a density of asexual stage P. falciparum >10K parasites/µL blood Secondary (0) = >37.5°C with presence of a density of asexual stage P. falciparum >0 parasites/µL blood Secondary (0*) = >37.5°C OR history of fever in the last 24 hrs with presence of a density of asexual stage P. falciparum >0 parasites/µL blood |
| Time Frame | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 200 | 200 |
| SA: Primary |
85
|
86
|
| SA: Secondary (200) |
17
|
13
|
| SA: Secondary (100) |
49
|
50
|
| SA: Secondary (10) |
103
|
107
|
| SA: Secondary (0) |
130
|
138
|
| SA: Secondary (0*) |
171
|
168
|
| MT: Primary |
80
|
79
|
| MT: Secondary (200) |
16
|
12
|
| MT: Secondary (100) |
46
|
47
|
| MT: Secondary (10) |
100
|
101
|
| MT: Secondary (0) |
127
|
131
|
| MT: Secondary (0*) |
173
|
168
|
| SA MT: Primary |
78
|
76
|
| SA MT: Secondary (200) |
15
|
12
|
| SA MT: Secondary (100) |
44
|
47
|
| SA MT: Secondary (10) |
96
|
100
|
| SA MT: Secondary (0) |
122
|
131
|
| SA MT: Secondary (0*) |
168
|
168
|
| Title | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time Frame | vaccination day plus post-vaccination days 1, 2, 3, and 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 200 | 200 |
| I1 - Pain |
140
70%
|
9
4.5%
|
| I1 - Swelling |
51
25.5%
|
1
0.5%
|
| I1 - Fever |
61
30.5%
|
11
5.5%
|
| I1 - Drowsiness |
1
0.5%
|
0
0%
|
| I1 - Loss of appetite |
27
13.5%
|
6
3%
|
| I1 - Irritability/fussiness |
14
7%
|
1
0.5%
|
| I2 - Pain |
113
56.5%
|
6
3%
|
| I2 - Swelling |
28
14%
|
0
0%
|
| I2 - Fever |
46
23%
|
3
1.5%
|
| I2 - Drowsiness |
1
0.5%
|
0
0%
|
| I2 - Loss of appetite |
21
10.5%
|
4
2%
|
| I2 - Irritability/fussiness |
7
3.5%
|
0
0%
|
| I3 - Pain |
66
33%
|
1
0.5%
|
| I3 - Swelling |
16
8%
|
1
0.5%
|
| I3 - Fever |
17
8.5%
|
6
3%
|
| I3 - Drowsiness |
0
0%
|
0
0%
|
| I3 - Loss of appetite |
5
2.5%
|
3
1.5%
|
| I3 - Irritability/fussiness |
3
1.5%
|
0
0%
|
| Title | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time Frame | vaccination day plus post-vaccination days 1, 2, 3, and 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 195 | 190 |
| I1 - Pain |
137
68.5%
|
8
4%
|
| I1 - Swelling |
50
25%
|
1
0.5%
|
| I1 - Fever |
61
30.5%
|
10
5%
|
| I1 - Drowsiness |
1
0.5%
|
0
0%
|
| I1 - Loss of appetite |
27
13.5%
|
6
3%
|
| I1 - Irritability/fussiness |
13
6.5%
|
1
0.5%
|
| I2 - Pain |
113
56.5%
|
5
2.5%
|
| I2 - Swelling |
28
14%
|
0
0%
|
| I2 - Fever |
46
23%
|
3
1.5%
|
| I2 - Drowsiness |
1
0.5%
|
0
0%
|
| I2 - Loss of appetite |
21
10.5%
|
3
1.5%
|
| I2 - Irritability/fussiness |
7
3.5%
|
0
0%
|
| I3 - Pain |
66
33%
|
1
0.5%
|
| I3 - Swelling |
15
7.5%
|
1
0.5%
|
| I3 - Fever |
17
8.5%
|
6
3%
|
| I3 - Drowsiness |
0
0%
|
0
0%
|
| I3 - Loss of appetite |
5
2.5%
|
3
1.5%
|
| I3 - Irritability/fussiness |
3
1.5%
|
0
0%
|
| Title | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time Frame | vaccination day and 29 subsequent days |
Outcome Measure Data
| Analysis Population Description |
|---|
| withdrawals |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 200 | 200 |
| I1 - Body as a whole general |
14
|
7
|
| I2 - Body as a whole general |
7
|
3
|
| I3 - Body as a whole general |
4
|
0
|
| I1 - History of fever |
13
|
7
|
| I2 - History of fever |
7
|
3
|
| I3 - History of fever |
4
|
0
|
| I1 - Fever |
1
|
0
|
| I2 - Fever |
0
|
0
|
| I3 - Fever |
0
|
0
|
| I1 - Rash maculo-papular |
0
|
0
|
| I2 - Rash maculo-papular |
0
|
0
|
| I3 - Rash maculo-papular |
1
|
0
|
| I1 - Gastroenteritis |
0
|
1
|
| I2 - Gastroenteritis |
0
|
0
|
| I3 - Gastroenteritis |
0
|
0
|
| I1 - Headache |
0
|
0
|
| I2 - Headache |
0
|
0
|
| I3 - Headache |
1
|
0
|
| I1 - Injection site inflammation |
0
|
0
|
| I2 - Injection site inflammation |
0
|
0
|
| I3 - Injection site inflammation |
0
|
1
|
| Title | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time Frame | vaccination day and 29 subsequent days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 195 | 190 |
| I1 - Body as a whole general |
13
|
6
|
| I2 - Body as a whole general |
7
|
2
|
| I3 - Body as a whole general |
4
|
0
|
| I1 - History of Fever |
12
|
6
|
| I2 - History of Fever |
7
|
2
|
| I3 - History ofFever |
4
|
0
|
| I1 - Fever |
1
|
0
|
| I2 - Fever |
0
|
0
|
| I3 - Fever |
0
|
0
|
| I1 - Rash maculo-papular |
0
|
0
|
| I2 - Rash maculo-papular |
0
|
0
|
| I3 - Rash maculo-papular |
1
|
0
|
| I1 - Gastroenteritis |
0
|
1
|
| I2 - Gastroenteritis |
0
|
0
|
| I3 - Gastroenteritis |
0
|
0
|
| I1 - Headache |
0
|
0
|
| I2 - Headache |
0
|
0
|
| I3 - Headache |
1
|
0
|
| I1 - Injection site inflammation |
0
|
0
|
| I2 - Injection site inflammation |
0
|
0
|
| I3 - Injection site inflammation |
0
|
1
|
| Title | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). Follow-up of SAEs continued for study duration (364 days) |
| Time Frame | vaccination day plus post-vaccine days 1, 2, 3, and 6; 30 day follow-up for unsolicited events and follow-up for SAEs to continue for duration of study (364 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 200 | 200 |
| Any solicited symptom |
195
97.5%
|
85
42.5%
|
| Any unsolicited AE |
197
98.5%
|
197
98.5%
|
| Any serious adverse event |
16
8%
|
8
4%
|
| Red blood cell |
176
88%
|
167
83.5%
|
| Resistance mechanism |
167
83.5%
|
160
80%
|
| Body as a whole general |
174
87%
|
115
57.5%
|
| Skin and appendages |
132
66%
|
132
66%
|
| Gastroentestinal |
128
64%
|
116
58%
|
| Application site |
176
88%
|
15
7.5%
|
| Respiratory |
61
30.5%
|
69
34.5%
|
| Vision |
36
18%
|
35
17.5%
|
| Psychiatric |
30
15%
|
3
1.5%
|
| Liver and biliary |
10
5%
|
12
6%
|
| Central and peripheral nervous system |
12
6%
|
9
4.5%
|
| White cell and reticuloendothelial |
6
3%
|
10
5%
|
| Urinary |
6
3%
|
4
2%
|
| Platelet bleeding and clotting |
1
0.5%
|
4
2%
|
| Musculoskeletal |
1
0.5%
|
3
1.5%
|
| Hearing and vestibular |
1
0.5%
|
2
1%
|
| Endocrine |
0
0%
|
2
1%
|
| Reproductive |
2
1%
|
0
0%
|
| Title | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time Frame | vaccination day plus 29 subsequent days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 195 | 190 |
| I1 - Any symptom |
157
|
22
|
| I1 - Local |
139
|
9
|
| I1 - Systemic |
82
|
16
|
| I2 - Any symptom |
131
|
10
|
| I2 - Local |
113
|
5
|
| I2 - Systemic |
62
|
6
|
| I3 - Any symptom |
76
|
10
|
| I3 - Local |
66
|
1
|
| I3 - Systemic |
21
|
9
|
| Title | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) |
|---|---|
| Description | Each subject participated in the study approximately 14 months with 7-day follow-up for solicited adverse events (five visits: vaccination day plus post-vaccination days 1, 2, 3, and 6) and 30-day follow-up for unsolicited events (vaccination day plus 29 subsequent days). I1 = Immunization 1 I2 = Immunization 2 I3 = Immunization 3 |
| Time Frame | vaccination day plus 29 subsequent days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) |
|---|---|---|
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Measure Participants | 200 | 200 |
| I1 - Any symptom |
160
|
24
|
| I1 - Local |
142
|
10
|
| I1 - Systemic |
83
|
17
|
| I2 - Any symptom |
131
|
11
|
| I2 - Local |
113
|
5
|
| I2 - Systemic |
62
|
7
|
| I3 - Any symptom |
76
|
10
|
| I3 - Local |
66
|
1
|
| I3 - Systemic |
21
|
9
|
Adverse Events
| Time Frame | 14 months to include follow-up for unsolicited adverse events 30 days post dose-3 | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | FMP1/AS02A | RabAvert (Rabies Vaccine) | ||
| Arm/Group Description | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months FMP1/AS02A: FMP1/AS02A candidate malaria vaccine | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine | ||
All Cause Mortality |
||||
| FMP1/AS02A | RabAvert (Rabies Vaccine) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/200 (0.5%) | 0/200 (0%) | ||
Serious Adverse Events |
||||
| FMP1/AS02A | RabAvert (Rabies Vaccine) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/200 (7.5%) | 8/200 (4%) | ||
| Blood and lymphatic system disorders | ||||
| Malaria | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Gastrointestinal disorders | ||||
| Gastroenteritis | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Immune system disorders | ||||
| Allergic reaction | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Infections and infestations | ||||
| Cellulitis | 2/200 (1%) | 2 | 0/200 (0%) | 0 |
| Cerebral malaria; severe anemia | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Pneumonia | 2/200 (1%) | 2 | 0/200 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||
| Foreign body in ear | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Foreign body in nostril | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Investigations | ||||
| Parasitemia >20% | 9/200 (4.5%) | 9 | 4/200 (2%) | 4 |
| Nervous system disorders | ||||
| Convulsions | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hyper-responsive airway disease | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| FMP1/AS02A | RabAvert (Rabies Vaccine) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 197/200 (98.5%) | 197/200 (98.5%) | ||
| Blood and lymphatic system disorders | ||||
| Malaria | 172/200 (86%) | 172 | 166/200 (83%) | 166 |
| Anemia | 4/200 (2%) | 4 | 7/200 (3.5%) | 7 |
| Severe malaria | 3/200 (1.5%) | 3 | 2/200 (1%) | 2 |
| Severe anemia | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Hemoglobinuria | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Anemai nemolytic | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Lymphocytopenia | 2/200 (1%) | 2 | 6/200 (3%) | 6 |
| Lymphadenopathy | 2/200 (1%) | 2 | 4/200 (2%) | 4 |
| Leukocytosis | 2/200 (1%) | 2 | 0/200 (0%) | 0 |
| Splenomegaly | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Lymphocytosis | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Thrombocytopenia | 1/200 (0.5%) | 1 | 4/200 (2%) | 4 |
| Ear and labyrinth disorders | ||||
| Earache | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Cerumen | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Endocrine disorders | ||||
| Sialoadenitis | 0/200 (0%) | 0 | 2/200 (1%) | 2 |
| Gastrointestinal disorders | ||||
| Diarrhea | 39/200 (19.5%) | 39 | 43/200 (21.5%) | 43 |
| Loss of appetite (anorexia) | 39/200 (19.5%) | 39 | 41/200 (20.5%) | 41 |
| Parasitic infection | 21/200 (10.5%) | 21 | 20/200 (10%) | 20 |
| Gastroenteritis | 14/200 (7%) | 14 | 21/200 (10.5%) | 21 |
| Abdominal pain | 13/200 (6.5%) | 13 | 13/200 (6.5%) | 13 |
| Vomiting | 13/200 (6.5%) | 13 | 12/200 (6%) | 12 |
| Stomatitis ulcerative | 6/200 (3%) | 6 | 6/200 (3%) | 6 |
| Glossitis | 6/200 (3%) | 6 | 1/200 (0.5%) | 1 |
| Diarrhea bloody | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Constipation | 3/200 (1.5%) | 3 | 1/200 (0.5%) | 1 |
| Tooth ache | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Stomatitis | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Rectal disorder | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Gingivitis | 2/200 (1%) | 2 | 0/200 (0%) | 0 |
| Abdominal distention | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Tooth caries | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Melena | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Loose tooth | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Abdominal rumbling | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| General disorders | ||||
| History of fever | 70/200 (35%) | 70 | 61/200 (30.5%) | 61 |
| Injury | 24/200 (12%) | 24 | 28/200 (14%) | 28 |
| Fever | 33/200 (16.5%) | 33 | 16/200 (8%) | 16 |
| Cellulitis | 3/200 (1.5%) | 3 | 7/200 (3.5%) | 7 |
| Edema | 3/200 (1.5%) | 3 | 1/200 (0.5%) | 1 |
| Pain | 2/200 (1%) | 2 | 0/200 (0%) | 0 |
| Abdomen enlarged | 0/200 (0%) | 0 | 2/200 (1%) | 2 |
| Varicella | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Rigors | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Malnutrion | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Malaise | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Injury (foreign body) | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Halitosis | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Face edema | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Astnenia | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Hepatic function abnormal | 10/200 (5%) | 10 | 12/200 (6%) | 12 |
| Hepatomegaly | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Immune system disorders | ||||
| Blepharitis | 1/200 (0.5%) | 1 | 3/200 (1.5%) | 3 |
| Infections and infestations | ||||
| Infection | 2/200 (1%) | 2 | 3/200 (1.5%) | 3 |
| Moniliasis | 4/200 (2%) | 4 | 0/200 (0%) | 0 |
| Herpes simplex | 2/200 (1%) | 2 | 1/200 (0.5%) | 1 |
| Abscess | 1/200 (0.5%) | 1 | 2/200 (1%) | 2 |
| Mastoiditis | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Conjunctivitis | 36/200 (18%) | 36 | 33/200 (16.5%) | 33 |
| Injury, poisoning and procedural complications | ||||
| Injection site inflammation | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Metabolism and nutrition disorders | ||||
| Weight decrease | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Dehydration | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 0/200 (0%) | 0 | 2/200 (1%) | 2 |
| Arthritis | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Arthralgia | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 6/200 (3%) | 6 | 4/200 (2%) | 4 |
| Convulsions | 4/200 (2%) | 4 | 3/200 (1.5%) | 3 |
| Hypokinesia | 2/200 (1%) | 2 | 1/200 (0.5%) | 1 |
| Dizziness | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Psychiatric disorders | ||||
| Irritability/fussiness | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Hellucination | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Drowsiness | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Renal and urinary disorders | ||||
| Urinary tract infection | 6/200 (3%) | 6 | 4/200 (2%) | 4 |
| Urine abnormal | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Dysuria | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Penis disorder | 2/200 (1%) | 2 | 0/200 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Upper respiratory tract infection | 167/200 (83.5%) | 167 | 159/200 (79.5%) | 159 |
| Rhinitis | 33/200 (16.5%) | 33 | 39/200 (19.5%) | 39 |
| Coughing | 20/200 (10%) | 20 | 30/200 (15%) | 30 |
| Pneumonia | 4/200 (2%) | 4 | 6/200 (3%) | 6 |
| Pharyngitis | 6/200 (3%) | 6 | 2/200 (1%) | 2 |
| Epistaxis | 2/200 (1%) | 2 | 1/200 (0.5%) | 1 |
| Rhonchi | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Asthma | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash pustular | 66/200 (33%) | 66 | 71/200 (35.5%) | 71 |
| Eczema | 54/200 (27%) | 54 | 46/200 (23%) | 46 |
| Dermatitis fungal | 33/200 (16.5%) | 33 | 27/200 (13.5%) | 27 |
| Otitis media | 8/200 (4%) | 8 | 8/200 (4%) | 8 |
| Folliculitis | 6/200 (3%) | 6 | 6/200 (3%) | 6 |
| Otitis externa | 1/200 (0.5%) | 1 | 9/200 (4.5%) | 9 |
| Rash | 6/200 (3%) | 6 | 2/200 (1%) | 2 |
| Rash maculo-papular | 6/200 (3%) | 6 | 1/200 (0.5%) | 1 |
| Urticaria | 1/200 (0.5%) | 1 | 5/200 (2.5%) | 5 |
| Pruritus | 1/200 (0.5%) | 1 | 3/200 (1.5%) | 3 |
| Arthropod infestation | 2/200 (1%) | 2 | 2/200 (1%) | 2 |
| Skin ulceration | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Pruritus genital | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Furunculosis | 1/200 (0.5%) | 1 | 1/200 (0.5%) | 1 |
| Skin discoloration | 1/200 (0.5%) | 1 | 0/200 (0%) | 0 |
| Rash erythematous | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Papule | 0/200 (0%) | 0 | 1/200 (0.5%) | 1 |
| Billous eruption | 0/200 (0%) | 0 | 1/200 (0.5%) | 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 | Bernhards R. Ogutu, PhD |
|---|---|
| Organization | Kenya Medical Research Institute |
| Phone | 254-57-22942 |
| bogutu@kisian.mimcom.net |
Responsible Party:
U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier:
NCT00223990
Other Study ID Numbers:
- A-13228
- IND 9202
- 1123
First Posted:
Sep 22, 2005
Last Update Posted:
Feb 12, 2021
Last Verified:
Feb 1, 2021