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| ID | Type | Description | Link |
|---|---|---|---|
| IND 9202 | Other Identifier | FDA | |
| 1123 | Other Identifier | WRAIR |
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| Name | Class |
|---|---|
| The PATH Malaria Vaccine Initiative (MVI) | OTHER |
| United States Agency for International Development (USAID) | FED |
| GlaxoSmithKline | INDUSTRY |
| Kenya Medical Research Institute |
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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMP1/AS02A | Experimental | FMP1/AS02A candidate malaria vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months |
|
| RabAvert (rabies vaccine) | Active Comparator | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMP1/AS02A | Biological | FMP1/AS02A candidate malaria vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
All subjects must satisfy the following criteria at study entry:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernhards Ogutu, M.D. | Kenya Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed Project, Kombewa Clinic | Kisumu | Nyanza Province | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15364429 | Background | 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. doi: 10.1016/j.vaccine.2004.07.023. | |
| 12742586 |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | FMP1/AS02A | 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 |
| FG001 | RabAvert (Rabies Vaccine) | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FMP1/AS02A | 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 |
| BG001 | RabAvert (Rabies Vaccine) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographics were reported per field station |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Posted | Number | events | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 |
|
14 months to include follow-up for unsolicited adverse events 30 days post dose-3
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FMP1/AS02A | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaria | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernhards R. Ogutu, PhD | Kenya Medical Research Institute | 254-57-22942 | bogutu@kisian.mimcom.net |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| OTHER |
| Walter Reed Army Institute of Research (WRAIR) | FED |
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)).
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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.
| RabAvert |
| Biological |
RabAvert rabies vaccine |
|
| starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 |
| Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | 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 | vaccination day plus post-vaccination days 1, 2, 3, and 6 |
| Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | 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 | vaccination day plus post-vaccination days 1, 2, 3, and 6 |
| Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | 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 | vaccination day and 29 subsequent days |
| Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | 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 | vaccination day and 29 subsequent days |
| Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | 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) | 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) |
| Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | 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 | vaccination day plus 29 subsequent days |
| Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | 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 | vaccination day plus 29 subsequent days |
| 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. doi: 10.1016/s0166-6851(03)00077-x. |
| 19262754 | Derived | Ogutu BR, Apollo OJ, McKinney D, Okoth W, Siangla J, Dubovsky F, Tucker K, Waitumbi JN, Diggs C, Wittes J, Malkin E, Leach A, Soisson LA, Milman JB, Otieno L, Holland CA, Polhemus M, Remich SA, Ockenhouse CF, Cohen J, Ballou WR, Martin SK, Angov E, Stewart VA, Lyon JA, Heppner DG, Withers MR; MSP-1 Malaria Vaccine Working Group. Blood stage malaria vaccine eliciting high antigen-specific antibody concentrations confers no protection to young children in Western Kenya. PLoS One. 2009;4(3):e4708. doi: 10.1371/journal.pone.0004708. Epub 2009 Mar 5. |
| Lost to Follow-up |
|
RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months
RabAvert: RabAvert rabies vaccine
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Months |
|
| Sex: Female, Male | Demographics were reported per field station. 193 participants completed the study in the FMP1/AS02A arm. 191 participants completed the study in the RabAvert arm. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Malaria Prevention - WRAIR Field Station | Baseline malaria prevention practiced by subjects at the WRAIR Field Station | Study specific baseline measures were presented per field station. 82 patients were randomized at this field station. | Count of Participants | Participants |
|
| Hemoglobin, g/dL - WRAIR Field Station | Baseline Hemoglobin values for subjects at the WRAIR Field Station | Study specific baseline measures were presented per field station. 82 patients were randomized at this field station. | Mean | Standard Deviation | g/dL |
|
| Sickle Cell Status - WRAIR Field Station | Participants at the WRAIR Field Station were analyzed for Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 82 participants were randomized at this field station. However, only 73 participants were analyzed for Sickle Cell Status and G6PD Deficiency. | Count of Participants | Participants |
|
| Alpha-Thalassemia - WRAIR Field Station | Baseline Alpha-Thalassemia values for subjects at the WRAIR Field Station | Study specific baseline measures were presented per field station. 82 patients were randomized at this field station. | Count of Participants | Participants |
|
| Parasite Density (par/µL blood) - WRAIR Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the WRAIR Field Station | Study specific baseline measures were presented per field station. 82 patients were randomized at this field station. | Mean | Standard Deviation | par/µL blood |
|
| Malaria Prevention - Abol Field Station | Baseline Malaria prevention practiced by subjects at the Abol Field Station | Study specific baseline measures were presented per field station. 26 patients were randomized at this field station. | Count of Participants | Participants |
|
| Hemoglobin, g/dL - Abol Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Abol Field Station | Study specific baseline measures were presented per field station. 26 patients were randomized at this field station. | Mean | Standard Deviation | g/dL |
|
| Sickle Cell Status - Abol Field Station | Participants at the Abol Field Station were analyzed for Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 26 patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Abol Field Station | Baseline Alpha-Thalassemia values for subjects at the Abol Field Station | Study specific baseline measures were presented per field station. 26 patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Density (par-µL blood)- Abol Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Abol Field Station | Study specific baseline measures were presented per field station. 26 patients were randomized at this field station. | Mean | Standard Deviation | par/µL blood |
|
| Baseline Malaria Prevention - Bar-Korwa Field Station | Baseline malaria prevention practiced by subjects at the Bar-Korwa Field Station | Study specific baseline measures were presented per field station. 12 patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Bar-Korwa Field Station | Baseline Hemoglobin values for subjects at the Bar-Korwa Field Station | Study specific baseline measures were presented per field station. 12 patients were randomized at this field station. | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Bar-Korwa Field Station | Participants at the Bar-Korwa Field Station were analyzed for baseline Sickle Cell status and G6PD Deficiency | Study specific baseline measures were presented per field station. 12 patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia- Bar-Korwa Field Station | Baseline Alpha-Thalassemia values for subjects at the Bar-Korwa Field Station | Study specific baseline measures were presented per field station. 12 patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Bar-Korwa Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Bar-Korwa Field Station | Study specific baseline measures were presented per field station. 12 patients were randomized at this field station. | Mean | Standard Deviation | par/µL |
|
| Baseline Malaria Prevention - Got-Aglu Field Station | Baseline malaria prevention practiced by subjects at the Got-Aglu Field Station | Study specific baseline measures were presented per field station. 31patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Got-Aglu Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Got-Aglu Field Station | Study specific baseline measures were presented per field station. 31patients were randomized at this field station. | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Got-Aglu Field Station | Participants at the Got-Aglu Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 31patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Got-Aglu Field Station | Baseline Alpha-Thalassemia values for subjects at the Got-Aglu Field Station | Study specific baseline measures were presented per field station. 31patients were randomized at this field station. | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Got-Aglu Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Got-Aglu Field Station | Study specific baseline measures were presented per field station. 31patients were randomized at this field station. | Mean | Standard Deviation | par/µL |
|
| Baseline Malarie Prevention - Kitare Field Station | Baseline malaria prevention practiced by subjects at the Kitare Field Station | Study specific baseline measures were presented per field station. 36 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Kitare Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Kitare Field Station | Study specific baseline measures were presented per field station. 36 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Kitare Field Station | Participants at the Kitare Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 36 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Kitare Field Station | Baseline Alpha-Thalassemia values for subjects at the Kitare Field Station | Study specific baseline measures were presented per field station. 36 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Kitare Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Kitare Field Station | Study specific baseline measures were presented per field station. 36 patients were randomized at this field station | Mean | Standard Deviation | par/µL |
|
| Baseline Malaria Prevention - Kuoyo-Kowe Field Station | Baseline malaria prevention practiced by subjects at the Kuoyo-Kowe Field Station | Study specific baseline measures were presented per field station. 35 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Kuoyo-Kowe Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Kuoyo-Kowe Field Station | Study specific baseline measures were presented per field station. 35 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Kuoyo-Kowe Field Station | Participants at the Kuoyo-Kowe Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 35 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Kuoyo-Kowe Field Station | Baseline Alpha-Thalassemia values for subjects at the Kuoyo-Kowe Field Station | Study specific baseline measures were presented per field station. 35 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Kuoyo-Kowe Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Kuoyo-Kowe Field Station | Study specific baseline measures were presented per field station. 35 patients were randomized at this field station | Mean | Standard Deviation | par/µL |
|
| Baseline Malaria Prevention - Manyanda Field Station | Baseline malaria prevention practiced by subjects at the Manyanda Field Station | Study specific baseline measures were presented per field station. 15 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Manyanda Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Manyanda Field Station | Study specific baseline measures were presented per field station. 15 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sick Cell Status - Manyanda Field Station | Participants at the Manyanda Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 15 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Manyanda Field Station | Baseline Alpha-Thalassemia values for subjects at the Manyanda Field Station | Study specific baseline measures were presented per field station. 15 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Manyanda Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Manyanda Field Station | Study specific baseline measures were presented per field station. 15 patients were randomized at this field station | Mean | Standard Deviation | par/µL |
|
| Baseline Malaria Prevention - Mirieri Field Station | Baseline malaria prevention practiced by subjects at the Mirieri Field Station | Study specific baseline measures were presented per field station. 29 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Mirieri Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Mirieri Field Station | Study specific baseline measures were presented per field station. 29 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Mirieri Field Station | Participants at the Mirieri Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 29 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Mirieri Field Station | Baseline Alpha-Thalassemia values for subjects at the Mirieri Field Station | Study specific baseline measures were presented per field station. 29 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Mirieri Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Mirieri Field Station | Study specific baseline measures were presented per field station. 29 patients were randomized at this field station | Mean | Standard Deviation | par/µL |
|
| Baseline Malaria Prevention - Nduru Kadero Field Station | Baseline malaria prevention practiced by subjects at the Nduru Kadero Field Station | Study specific baseline measures were presented per field station. 23 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Nduru Kadero Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Nduru Kadero Field Station | Study specific baseline measures were presented per field station. 23 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Nduru Kadero Field Station | Participants at the Nduru Kadero Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 23 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Nduru Kadero Field Station | Baseline Alpha-Thalassemia values for subjects at the Nduru Kadero Field Station | Study specific baseline measures were presented per field station. 23 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Nduru Kadero Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Nduru Kadero Field Station | Study specific baseline measures were presented per field station. 23 patients were randomized at this field station | Mean | Standard Deviation | par/µL |
|
| Baseline Malaria Prevention - Oruga Field Station | Baseline malaria prevention practiced by subjects at the Oruga Field Station | Study specific baseline measures were presented per field station. 37 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Oruga Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Oruga Field Station | Study specific baseline measures were presented per field station. 37 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Oruga Field Station | Participants at the Oruga Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 37 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Oruga Field Station | Baseline Alpha-Thalassemia values for subjects at the Oruga Field Station | Study specific baseline measures were presented per field station. 37 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Oruga Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Oruga Field Station | Study specific baseline measures were presented per field station. 37 patients were randomized at this field station | Mean | Standard Deviation | par/µL blood |
|
| Baseline Malaria Prevention - Osewre Field Station | Baseline malaria prevention practiced by subjects at the Osewre Field Station | Study specific baseline measures were presented per field station. 20 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Osewre Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Osewre Field Station | Study specific baseline measures were presented per field station. 20 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Osewre Field Station | Participants at the Osewre Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 20 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Osewre Field Station | Baseline Alpha-Thalassemia values for subjects at the Osewre Field Station | Study specific baseline measures were presented per field station. 20 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Osewre Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Osewre Field Station | Study specific baseline measures were presented per field station. 20 patients were randomized at this field station | Mean | Standard Deviation | par/µL blood |
|
| Baseline Malaria Prevention - Ranen Field Station | Baseline malaria prevention practiced by subjects at the Ranen Field Station | Study specific baseline measures were presented per field station. 22 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Ranen Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Ranen Field Station | Study specific baseline measures were presented per field station. 22 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Ranen Field Station | Participants at the Ranen Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 22 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Ranen Field Station | Baseline Alpha-Thalassemia values for subjects at the Ranen Field Station | Study specific baseline measures were presented per field station. 22 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Ranen Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Ranen Field Station | Study specific baseline measures were presented per field station. 22 patients were randomized at this field station | Mean | Standard Deviation | par/µL blood |
|
| Baseline Malaria Prevention - Reru Field Station | Baseline malaria prevention practiced by subjects at the Reru Field Station | Study specific baseline measures were presented per field station. 17 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Hemoglobin (g/dL) - Reru Field Station | Baseline Hemoglobin values (g/dL) for subjects at the Reru Field Station | Study specific baseline measures were presented per field station. 17 patients were randomized at this field station | Mean | Standard Deviation | g/dL |
|
| Baseline Sickle Cell Status - Reru Field Station | Participants at the Reru Field Station were analyzed for baseline Sickle Cell status and G6PD deficiency | Study specific baseline measures were presented per field station. 17 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Alpha-Thalassemia - Reru Field Station | Baseline Alpha-Thalassemia values for subjects at the Reru Field Station | Study specific baseline measures were presented per field station. 17 patients were randomized at this field station | Count of Participants | Participants |
|
| Baseline Parasite Density (par/µL blood) - Reru Field Station | Baseline Parasite Density values (par/µL blood) for subjects at the Reru Field Station | Study specific baseline measures were presented per field station. 17 patients were randomized at this field station | Mean | Standard Deviation | par/µL blood |
|
| Description |
|---|
| OG000 | FMP1/AS02A | 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 |
| OG001 | RabAvert (Rabies Vaccine) | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine |
|
|
| Secondary | 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 | 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 | Posted | Number | events | starting 14 days after the 3rd vaccination (day 71), every 28 days and ending on day 240 |
|
|
|
| Secondary | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - Intent to Treat (ITT) Population | 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 | Posted | Number | participants | vaccination day plus post-vaccination days 1, 2, 3, and 6 |
|
|
|
| Secondary | Vaccine-Related Solicited Symptoms During 7-day Follow-up Period by Immunization - According to Protocol (ATP) Population | 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 | Posted | Count of Participants | Participants | vaccination day plus post-vaccination days 1, 2, 3, and 6 |
|
|
|
| Secondary | Vaccine-Related Unsolicited Adverse Events by Immunization - Intent to Treat (ITT) Population | 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 | withdrawals | Posted | Number | adverse events | vaccination day and 29 subsequent days |
|
|
|
| Secondary | Vaccine-Related Unsolicited Adverse Events by Immunization - According to Protocol (ATP) Population | 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 | Posted | Number | adverse events | vaccination day and 29 subsequent days |
|
|
|
| Secondary | Number of Patients Who Showed Symptoms, Unsolicited Adverse Events, and Serious Adverse Events by Immunization | 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) | Posted | Number | Number of Participants | 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) |
|
|
|
| Secondary | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - According to Protocol (ATP) | 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 | Posted | Number | adverse events | vaccination day plus 29 subsequent days |
|
|
|
| Secondary | Vaccine-Related Local and Systemic Solicited Adverse Events by Immunization - Intent to Treat (ITT) | 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 | Posted | Number | adverse events | vaccination day plus 29 subsequent days |
|
|
|
| 1 |
| 200 |
| 15 |
| 200 |
| 197 |
| 200 |
| EG001 | RabAvert (Rabies Vaccine) | RabAvert vaccine was administered IM in the left anterolateral thigh muscle at 0, 1, and 2 months RabAvert: RabAvert rabies vaccine | 0 | 200 | 8 | 200 | 197 | 200 |
| Cerebral malaria; severe anemia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Convulsions | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foreign body in ear | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Foreign body in nostril | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaria | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyper-responsive airway disease | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Parasitemia >20% | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Severe malaria | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Severe anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hemoglobinuria | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anemai nemolytic | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Moniliasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash pustular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dermatitis fungal | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Otitis media | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Otitis externa | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthropod infestation | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus genital | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Furunculosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin discoloration | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Billous eruption | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Loss of appetite (anorexia) | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Parasitic infection | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Stomatitis ulcerative | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea bloody | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tooth ache | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rectal disorder | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tooth caries | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Melena | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Loose tooth | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal rumbling | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| History of fever | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injury | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cellulitis | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Edema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdomen enlarged | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Varicella | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rigors | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malnutrion | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injury (foreign body) | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Halitosis | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Face edema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Astnenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Blepharitis | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Convulsions | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypokinesia | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lymphocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urine abnormal | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Irritability/fussiness | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hellucination | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Drowsiness | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Penis disorder | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Weight decrease | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Earache | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cerumen | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sialoadenitis | Endocrine disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Injection site inflammation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| D000079426 |
| Vector Borne Diseases |
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| Male |
|
| SA: Secondary (100) |
|
| SA: Secondary (10) |
|
| SA: Secondary (0) |
|
| SA: Secondary (0*) |
|
| MT: Primary |
|
| MT: Secondary (200) |
|
| MT: Secondary (100) |
|
| MT: Secondary (10) |
|
| MT: Secondary (0) |
|
| MT: Secondary (0*) |
|
| SA MT: Primary |
|
| SA MT: Secondary (200) |
|
| SA MT: Secondary (100) |
|
| SA MT: Secondary (10) |
|
| SA MT: Secondary (0) |
|
| SA MT: Secondary (0*) |
|
| I1 - Fever |
|
| I1 - Drowsiness |
|
| I1 - Loss of appetite |
|
| I1 - Irritability/fussiness |
|
| I2 - Pain |
|
| I2 - Swelling |
|
| I2 - Fever |
|
| I2 - Drowsiness |
|
| I2 - Loss of appetite |
|
| I2 - Irritability/fussiness |
|
| I3 - Pain |
|
| I3 - Swelling |
|
| I3 - Fever |
|
| I3 - Drowsiness |
|
| I3 - Loss of appetite |
|
| I3 - Irritability/fussiness |
|
| I1 - Fever |
|
| I1 - Drowsiness |
|
| I1 - Loss of appetite |
|
| I1 - Irritability/fussiness |
|
| I2 - Pain |
|
| I2 - Swelling |
|
| I2 - Fever |
|
| I2 - Drowsiness |
|
| I2 - Loss of appetite |
|
| I2 - Irritability/fussiness |
|
| I3 - Pain |
|
| I3 - Swelling |
|
| I3 - Fever |
|
| I3 - Drowsiness |
|
| I3 - Loss of appetite |
|
| I3 - Irritability/fussiness |
|
| I2 - Body as a whole general |
|
|
| I3 - Body as a whole general |
|
|
| I1 - History of fever |
|
|
| I2 - History of fever |
|
|
| I3 - History of fever |
|
|
| I1 - Fever |
|
|
| I2 - Fever |
|
|
| I3 - Fever |
|
|
| I1 - Rash maculo-papular |
|
|
| I2 - Rash maculo-papular |
|
|
| I3 - Rash maculo-papular |
|
|
| I1 - Gastroenteritis |
|
|
| I2 - Gastroenteritis |
|
|
| I3 - Gastroenteritis |
|
|
| I1 - Headache |
|
|
| I2 - Headache |
|
|
| I3 - Headache |
|
|
| I1 - Injection site inflammation |
|
|
| I2 - Injection site inflammation |
|
|
| I3 - Injection site inflammation |
|
|
| I3 - Body as a whole general |
|
| I1 - History of Fever |
|
| I2 - History of Fever |
|
| I3 - History ofFever |
|
| I1 - Fever |
|
| I2 - Fever |
|
| I3 - Fever |
|
| I1 - Rash maculo-papular |
|
| I2 - Rash maculo-papular |
|
| I3 - Rash maculo-papular |
|
| I1 - Gastroenteritis |
|
| I2 - Gastroenteritis |
|
| I3 - Gastroenteritis |
|
| I1 - Headache |
|
| I2 - Headache |
|
| I3 - Headache |
|
| I1 - Injection site inflammation |
|
| I2 - Injection site inflammation |
|
| I3 - Injection site inflammation |
|
| Any serious adverse event |
|
| Red blood cell |
|
| Resistance mechanism |
|
| Body as a whole general |
|
| Skin and appendages |
|
| Gastroentestinal |
|
| Application site |
|
| Respiratory |
|
| Vision |
|
| Psychiatric |
|
| Liver and biliary |
|
| Central and peripheral nervous system |
|
| White cell and reticuloendothelial |
|
| Urinary |
|
| Platelet bleeding and clotting |
|
| Musculoskeletal |
|
| Hearing and vestibular |
|
| Endocrine |
|
| Reproductive |
|
| I1 - Systemic |
|
| I2 - Any symptom |
|
| I2 - Local |
|
| I2 - Systemic |
|
| I3 - Any symptom |
|
| I3 - Local |
|
| I3 - Systemic |
|
| I1 - Systemic |
|
| I2 - Any symptom |
|
| I2 - Local |
|
| I2 - Systemic |
|
| I3 - Any symptom |
|
| I3 - Local |
|
| I3 - Systemic |
|