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| ID | Type | Description | Link |
|---|---|---|---|
| U19AI065683 | U.S. NIH Grant/Contract | View source | |
| 2U01AI065683-06 | U.S. NIH Grant/Contract | View source | |
| GSKBio: Malaria 051 (106874) |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Walter Reed Army Institute of Research (WRAIR) | FED |
| GlaxoSmithKline | INDUSTRY |
The purpose of this study is to test the safety and dosages of a malaria vaccine in 100 children, 1-6 years old, in Bandiagara, Mali. The study is testing the safety of the vaccine when it is given to people who are regularly exposed to malaria and it will provide information regarding optimal vaccine dosage. This study will compare 3 injections of different vaccine doses to a rabies vaccine that is already approved. During the study, the child's health will be checked in the clinic and during home visits. Children may participate for about 14 months, and blood will be taken from each child throughout the study. If the child becomes sick from malaria, he/she will be treated. Information from this study may be used to develop a malaria vaccine that will help control the disease.
This study is a randomized, controlled, dose-escalation, phase I trial of the FMP2.1/AS02A malaria vaccine, using rabies vaccine as a control. This study is linked to DMID protocol 07-0003. The primary objective of this study is to evaluate the safety and reactogenicity of FMP2.1/AS02A in children naturally exposed to P. falciparum malaria infection. The secondary objective is to measure the magnitude and duration of antibody response to FMP2.1 by enzyme-linked immunosorbent assay (ELISA). One hundred healthy children aged 1-6 years in Bandiagara, Mali, will be randomized to 1 of 3 possible groups. Twenty subjects will be enrolled in cohort 1 and 40 subjects each in cohorts 2 and 3. Children within each cohort will be randomized in a 3:1 ratio to receive 10, 25 or 50 micrograms of FMP2.1 (in cohorts 1, 2 and 3, respectively) adjuvanted with a proportionate volume of the AS02A, or rabies vaccine. Thus a total of 75 children will receive the malaria vaccine and 25 the rabies vaccine. Immunizations will be given on days 0, 30 and 60 in a staggered fashion, with the first administrations of the 25 and 50 microgram dose levels of FMP2.1 following the first administration of the 10 and 25 microgram dose levels, respectively, by 2-3 weeks. Solicited adverse events will be recorded on the days of immunization and days 1, 2, 3 and 7 after each immunization, and unsolicited adverse events will be recorded for 30 days after each immunization. Children will be followed for 1 year after the last immunization. Sera will be collected for anti-FMP2.1 antibody titers on the days of immunization and 14 days after each immunization as well as 3, 6, 9 and 12 months after the first immunization. Each child will participate in the study for up to 414 days, which includes the screening period. The primary outcome measures include: occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination), occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days); and occurrence of serious adverse events throughout the study period. The secondary outcome measure is titers and activity of anti-FMP2.1 antibody at each time point where serology samples are analyzed, measured by ELISA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: FMP2.1/AS02A 10 mcg dose or rabies vaccine. | Experimental | 20 children will be randomized to receive either the 10 mcg dose of FMP2.1/AS02A (n=15) or rabies vaccine (n=5) on study days 0, 30 +/- 7, and 60 +/- 7. |
|
| Group 2: FMP2.1/AS02A 25 mcg dose or rabies vaccine. | Experimental | 40 children will be randomized to receive either the 25 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7. |
|
| Group 3: FMP2.1/AS02A 50 mcg dose or rabies vaccine. | Experimental | 40 children will be randomized to receive either the 50 mcg dose of FMP2.1/AS02A (n=30) or rabies vaccine (n=10) on study days 0, 30 +/- 7, and 60 +/- 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMP2.1/AS02A | Biological | FMP2.1 will be reconstituted in AS02A adjuvant. Dosages: 10, 25, or 50 mcg of FMP2.1 or 0.1, 0.25 or 0.5 mL of FMP2.1/AS02A administered by intramuscular injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. | The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions. | 7 Days following any vaccination |
| Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60. | The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions. | Day of vaccination and 30 subsequent days. |
| Number of Subjects Spontaneously Reporting Any Serious Adverse Event. | Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes. | 1 year after the last vaccination. |
| Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. | The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions. | 7 Days following any vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Day 0 |
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bamako, Malaria Research and Training Center | Bamako | Mali |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20140214 | Result | Thera MA, Doumbo OK, Coulibaly D, Laurens MB, Kone AK, Guindo AB, Traore K, Sissoko M, Diallo DA, Diarra I, Kouriba B, Daou M, Dolo A, Baby M, Sissoko MS, Sagara I, Niangaly A, Traore I, Olotu A, Godeaux O, Leach A, Dubois MC, Ballou WR, Cohen J, Thompson D, Dube T, Soisson L, Diggs CL, Takala SL, Lyke KE, House B, Lanar DE, Dutta S, Heppner DG, Plowe CV. Safety and immunogenicity of an AMA1 malaria vaccine in Malian children: results of a phase 1 randomized controlled trial. PLoS One. 2010 Feb 4;5(2):e9041. doi: 10.1371/journal.pone.0009041. |
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Parents in Bandiagara Mali were made aware of the study by a radio announcement and voluntarily brought their children to the Bandiagara Malaria Project (BMP) clinic on the campus of the Bandiagara District Hospital in Bandiagara, Mali. The first subject was enrolled on November 3, 2006 and the final subject was enrolled on December 12, 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | FMP2.1/AS02A 10 Mcg | Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| FG001 | FMP2.1/AS02A 25 Mcg | Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| FG002 | FMP2.1/AS02A 50 Mcg | Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| FG003 | RabAvert(R) | Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FMP2.1/AS02A 10 Mcg | Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| BG001 | FMP2.1/AS02A 25 Mcg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Occurrence of Solicited Systemic Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. | The number of participants reporting drowsiness irritability/fussiness, loss of appetite, vomiting, and feverishness. Participants are counted only once but may have experienced symptoms on multiple occasions. | This outcome includes all enrolled subjects. | Posted | Number | Participants | 7 Days following any vaccination |
|
Solicited symptoms were recorded 7-day surveillance period (day of vaccination and study days 1, 2, 3 and 7) after each dose, and unsolicited AEs were recorded for 30 days after each immunization. SAEs were collected through 1 year post last dose.
The solicited symptoms are reported separately after each vaccination. The occurrence of a solicited symptom on any day(s) at any severity within the 7-day period was considered one event
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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 | FMP2.1/AS02A 10 Mcg | Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | MedDRA (11.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher V. Plowe | University of Maryland School of Medicine | 410-706-3082 | cplowe@medicine.umaryland.edu |
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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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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| University of Maryland, Baltimore |
| OTHER |
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| Rabies vaccine (RabAvert) | Biological | RabAvert, white, freeze-dried vaccine for reconstitution with diluent. Dosage: 1.0 mL of rabies vaccine. |
|
This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA.
| Day 30 +/- 7 days |
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Day 60 +/- 7 days |
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Day 90 +/- 10 days |
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Day 180 +/- 14 days |
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272. | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Day 272 +/- 14 days |
| Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Day 364 +/- 14 days |
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| BG002 | FMP2.1/AS02A 50 Mcg | Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| BG003 | RabAvert(R) | Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| OG002 | FMP2.1/AS02A 50 Mcg | Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. |
| OG003 | RabAvert(R) | Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60. |
|
|
| Primary | Occurrence of Unsolicited Symptoms During a 30-day Surveillance Period Following Vaccinations at Days 0, 30, and 60. | The number of participants spontaneously reporting any symptom (defined as any Adverse Event considered associated with the product) within 30 days of any vaccination. Participants are counted only once but may have experienced events on multiple occasions. | This outcome includes all enrolled subjects. | Posted | Number | Participants | Day of vaccination and 30 subsequent days. |
|
|
|
| Primary | Number of Subjects Spontaneously Reporting Any Serious Adverse Event. | Any untoward medical occurrence that resulted in death, persistent/significant disability/incapacity, required in-patient hospitalization or prolongation thereof, was life threatening or a congenital anomaly/birth defect in offspring of a study subject; or may have jeopardized the participant or required intervention to prevent one of the outcomes. | This outcome includes all enrolled subjects. | Posted | Number | Participants | 1 year after the last vaccination. |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 0 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 0 |
|
|
|
| Primary | Occurrence of Solicited Local Symptoms During a 7-day Surveillance Period (Systematically Collected) Following Vaccinations at Days 0, 30, and 60. | The number of participants reporting pain, swelling and erythema. Participants are counted only once but may have experienced symptoms on multiple occasions. | This outcome includes all enrolled subjects. | Posted | Number | Participants | 7 Days following any vaccination |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 30 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 30 +/- 7 days |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 60 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 60 +/- 7 days |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 90 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 90 +/- 10 days |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 180 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 180 +/- 14 days |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 272. | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point are available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 272 +/- 14 days |
|
|
|
| Secondary | Anti-FMP2.1 Antibody Titers Measured by ELISA, at Day 364 | This outcome is the mean of the log anti-FMP2.1 antibody response measured by ELISA. | Participants included are those meeting all eligibility criteria, and who have received at least one immunization with any of the study or control vaccines and for whom immunogenicity data at the indicated time point is available. | Posted | Mean | 95% Confidence Interval | log anti-FMP2.1 titer | Day 364 +/- 14 days |
|
|
|
| 1 |
| 15 |
| 15 |
| 15 |
| EG001 | FMP2.1/AS02A 25 Mcg | Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. | 1 | 30 | 30 | 30 |
| EG002 | FMP2.1/AS02A 50 Mcg | Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60. | 0 | 30 | 30 | 30 |
| EG003 | RabAvert(R) | Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60. | 2 | 25 | 25 | 25 |
| White blood cell count increased | Investigations | MedDRA (8.1) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dental discomfort | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Rectal prolapse | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Tooth loss | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyrexia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Amoebic dysentery | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Giardiasis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Hepatitis A | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Herpetic stomatitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Hymenolepiasis | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Infection parasitic | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Mumps | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (11.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (9.0) | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Streptococcal infection | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
|
| Trichomoniasis intestinal | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (10.1) | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (11.0) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (9.0) | Non-systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA (10.0) | Non-systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
|
| Pica | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Non-systematic Assessment |
|
| Vomiting - post dose 1 | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Injection site pain - post dose 1 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Injection site swelling - post dose 1 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia - post dose 1 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Anorexia - post dose 1 | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Injection site pain - post dose 2 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Injection site swelling - post dose 2 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia - post dose 2 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Anorexia - post dose 2 | Metabolism and nutrition disorders | MedDRA (12.0) | Systematic Assessment |
|
| Vomiting - post dose 3 | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment |
|
| Injection site pain - post dose 3 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Injection site swelling - - post dose 3 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
| Pyrexia - post dose 3 | General disorders | MedDRA (12.0) | Systematic Assessment |
|
Not provided
| D000079426 |
| Vector Borne Diseases |
| Swelling |
|
| Erythema |
|