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| ID | Type | Description | Link |
|---|---|---|---|
| IND 11220 | Other Identifier | FDA |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Walter Reed Army Institute of Research (WRAIR) | FED |
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The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.
The study comprises of 3 groups and the participating subjects will be randomly allocated to one of the three groups. The first group will receive RTS,S/AS01B, the second group will receive RTS,S/AS02A and the third group will receive rabies vaccine. Immunization will be given by IM injection on 0, 1, 2 month schedule. Infants will be followed up daily for 7 days for solicited symptoms and 30 days for unsolicited symptoms after each vaccine dose. Serious adverse events will be recorded throughout the study period. A week prior to Dose 3, subjects will be treated with a licenced anti-malarial drug. Starting from two weeks after Dose 3, the subjects will be monitored for a 14-week duration for detection of malaria infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VACC 1 (RTS, S/AS01B) | Experimental | RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
|
| VACC 2 (RTS, S/AS02A) | Experimental | RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
|
| Rabipur (Rabies) Vaccine | Active Comparator | Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RTS, S/AS01B | Biological | 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B | Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days). | 7 day follow-up (day of vaccination + 6 days) |
| Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Grade 3 unsolicited symptoms reported following any number of administered doses | 6.5 months |
| Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort) | 7 day follow-up period (day of vaccination + 6 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Occurrence of SAEs | Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12) | months 6.5 thru 12 |
| Safety: Occurrence of SAEs | Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12) |
| Measure | Description | Time Frame |
|---|---|---|
| Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE | Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected >10 mIU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination | Prevaccination |
| Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| U.S. Army Research Unit-Kenya | Kisumu | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19649245 | Derived | Polhemus ME, Remich SA, Ogutu BR, Waitumbi JN, Otieno L, Apollo S, Cummings JF, Kester KE, Ockenhouse CF, Stewart A, Ofori-Anyinam O, Ramboer I, Cahill CP, Lievens M, Dubois MC, Demoitie MA, Leach A, Cohen J, Ballou WR, Heppner DG Jr. Evaluation of RTS,S/AS02A and RTS,S/AS01B in adults in a high malaria transmission area. PLoS One. 2009 Jul 31;4(7):e6465. doi: 10.1371/journal.pone.0006465. |
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GSK and WRAIR
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255 subjects were enrolled and randomized 1:1:1 into each arm at Kombewa Clinic, US Army Medical Research Unit, Kisumu Kenya.
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| ID | Title | Description |
|---|---|---|
| FG000 | RTS, S/AS02A | RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
| FG001 | RTS, S/AS01B | RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
| FG002 | Rabipur (Rabies) Vaccine | Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RTS, S/AS02A | RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
| BG001 | RTS, S/AS01B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Safety: Proportion of Subjects With Grade 3 Solicited and Unsolicited General Reactions After Vaccination of RTS, S/AS02A and RTS, S/AS01B | Proportion of subjects with grade 3 solicited and unsolicited general reactions after vaccination of RTS, S/AS02A and RTS, S/AS01B during a 7 day follow-up period (day of vaccination + 6 days). | Rabipur was a comparator vaccine and not relevant to results of this primary outcome. Results for Rabipur were not presented in data table. | Posted | Number | 95% Confidence Interval | participants | 7 day follow-up (day of vaccination + 6 days) |
|
12 months
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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 | (RTS, S/AS01B) | RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| LTC Mark Polhemus MD, MC | Kombewa Clinic, US Army Medical Research Unit, Kisumo Kenya | 877-379-3788 | GSKClinicalSupportHD@gsk.com |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C526041 | RTS,S-AS01B vaccine |
| C493155 | RTS,S-AS02A vaccine |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| RTS, S/AS02A | Biological | 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
|
| Rabipur (Rabies) Vaccine | Biological | 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months |
|
| months 0 thru 12 |
| Occurrence of Hematology Parameters Below Normal Range | Occurrence of hematology parameters below normal range (Total Cohort) | Days 0, 6, 66, and 90; Months 6 and 12 |
| Occurrence of Biochemistry Parameters Above Normal Ranges | Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort) | Days 0, 6, and 90 |
Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) |
| Day 90 |
| Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) | Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12) | Month 12 |
| Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE | Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PRE=Prevaccination | Prevaccination |
| Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90) | Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(D90)= post dose 3 (Day 90) | Day 90 |
| Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12) | Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(M12)= post dose 3 (Month 12) | Month 12 |
| Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE | Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PRE=Prevaccination | Prevaccination |
| Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90) | Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(D90)= post dose 3 (Day 90) | Day 90 |
| Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12) | Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(M12)= post dose 3 (Month 12) | Month 12 |
| Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE | Geometric mean antibody titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PRE=Prevaccination | Prevaccination |
| Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90) | Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(D90)= post dose 3 (Day 90) | Day 90 |
| Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12) | Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(M12)= post dose 3 (Month 12) | Month 12 |
| Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE | Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination | Prevaccination |
| Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) | Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | Day 90 |
| Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) | Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12) | Month 12 |
| Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination | Prevaccination |
| Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PII(D60)= post dose 2 (day 60) | 1 month post dose 2 |
| Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90) | 1 month post dose 3 |
| Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5) | 4 months post dose 3 |
| Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12) | 10 months post dose 3 |
| Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination | PRE |
| Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60) | post dose 2 (day 60) |
| Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | post dose 3 (day 90) |
| Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5) | post dose 3 (month 6.5) |
| Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination | Prevaccination |
| Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3. PII(D60)= post dose 2 (day 60) | 1 month post dose 2 |
| Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90) | 1 month post dose 3 |
| Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5) | 4 months post dose 3 |
| Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12) | 10 months post dose 3 |
| Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination | Prevaccination |
| Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60) | post dose 2 (day 60) |
| Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | post dose 3 (day 90) |
| Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5) | post dose 3 (month 6.5) |
| Efficacy: Vaccine Efficacy Against P. Falciparum Infection | Number of subjects with an episode of parasitemia (first recording of infection of asexual stage falciparum parasites >0 detected by active detection of infection (ADI) or passive case detection) | 14 days after dose 3 and extending for 14 weeks |
| Percentage of Participants With Positive and Negative Parasite Density | Percentage of participants with positive and negative parasite density at month 6.5 | at month 6.5 |
| Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia | Geometric Mean Antibody Titers (GMTs) of Asexual P. falciparum parasitemia at Month 6.5 | Month 6.5 |
| Lost to Follow-up |
|
RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.
| BG002 | Rabipur (Rabies) Vaccine | Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| RTS, S/AS01B |
RTS, S/AS01B: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. |
|
|
| Primary | Safety: Number of Administered Doses Eliciting Grade 3 Unsolicited Symptoms | Grade 3 unsolicited symptoms reported following any number of administered doses | Posted | Number | 95% Confidence Interval | administered doses | 6.5 months | Doses | Doses |
|
|
|
| Primary | Safety: Number of Doses Eliciting Solicited Local Symptoms Reported Over 7 Day Follow-up Period | Incidence overall solicited general and local reactions over 7 day follow-up period after dose 1, 2 and 3 (Total Cohort) | number of administered doses | Posted | Number | Doses | 7 day follow-up period (day of vaccination + 6 days) | Doses | Doses |
|
|
|
| Secondary | Safety: Occurrence of SAEs | Percentage of subjects experiencing SAEs classified by MedRA System Organ Class and Preferred Term (Month 6.5-12) | Number of subjects with at least one administered dose | Posted | Number | 95% Confidence Interval | % of subjects | months 6.5 thru 12 |
|
|
|
| Secondary | Safety: Occurrence of SAEs | Percentage of subjects reporting SAEs classified by MedDRA System Organ Class and Preferred Term (Month 0-12) | Number of subjects with at least one administered dose | Posted | Number | 95% Confidence Interval | % of subjects reporting symptom | months 0 thru 12 |
|
|
|
| Secondary | Occurrence of Hematology Parameters Below Normal Range | Occurrence of hematology parameters below normal range (Total Cohort) | Posted | Count of Participants | Participants | Days 0, 6, 66, and 90; Months 6 and 12 |
|
|
|
| Secondary | Occurrence of Biochemistry Parameters Above Normal Ranges | Occurrence of parameters of biochemical monitoring above normal ranges (Total Cohort) | Posted | Count of Participants | Participants | Days 0, 6, and 90 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PRE | Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected >10 mIU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination | The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | Prevaccination |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(D90) | Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 90 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-HBs Antibodies by Infection Status PIII(M12) | Seropositivity rates and GMTs for Anti-HBs antibodies by infection status (Total Cohort) Seropositive >3.3 mlU/mL; Seroprotected: >10 mlU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12) | The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PRE | Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PRE=Prevaccination | Subject with available results | Posted | Count of Participants | Participants | Prevaccination |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(D90) | Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(D90)= post dose 3 (Day 90) | Subjects with available results | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-HBs Antibodies by Vaccine Group PIII(M12) | Seropositivity rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seropositive >3.3 mlU/ML PIII(M12)= post dose 3 (Month 12) | Subjects with available results | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Other Pre-specified | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PRE | Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PRE=Prevaccination | Subjects with available results | Posted | Count of Participants | Participants | Prevaccination |
|
|
|
| Other Pre-specified | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (D90) | Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(D90)= post dose 3 (Day 90) | Subject with available results | Posted | Count of Participants | Participants | Day 90 |
|
|
|
| Other Pre-specified | Seroprotection Rates for Anti-HBs Antibodies by Vaccine Group PIII (M12) | Seroprotection rates for Anti-HBs antibodies by vaccine group (ATP Cohort for Immunogenicity). Seroprotected >10 mlU/mL PIII(M12)= post dose 3 (Month 12) | Subjects with available results | Posted | Count of Participants | Participants | Month 12 |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PRE | Geometric mean antibody titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PRE=Prevaccination | Subjects with available results | Posted | Geometric Mean | 95% Confidence Interval | titers | Prevaccination |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (D90) | Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(D90)= post dose 3 (Day 90) | Subjects with available results | Posted | Geometric Mean | 95% Confidence Interval | titers | Day 90 |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Vaccine Group PIII (M12) | Geometric mean titers (GMTs) for Anti-HBs antibodies by vaccine group (According to protocol (ATP) Cohort for Immunogenicity) PIII(M12)= post dose 3 (Month 12) | Subjects with available results | Posted | Geometric Mean | 95% Confidence Interval | titers | Month 12 |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PRE | Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PRE= Prevaccination | The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titer | Prevaccination |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (D90) | Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 90 |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-HBs Antibodies by Infection Status PIII (M12) | Geometric mean titers (GMTs) for Anti-HBs antibodies by infection status (Total Cohort) Infection defined as P. falciparum asexual parasitemia >0 PIII(M12)= post dose 3 (month 12) | The Total Vaccinated Cohort includes all vaccinated subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titer | Month 12 |
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|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PRE | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination | Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine) | Posted | Geometric Mean | 95% Confidence Interval | titers | Prevaccination |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PII (D60) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PII(D60)= post dose 2 (day 60) | Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine) | Posted | Geometric Mean | 95% Confidence Interval | titers | 1 month post dose 2 |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (D90) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90) | Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine) | Posted | Geometric Mean | 95% Confidence Interval | titers | 1 month post dose 3 |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M6.5) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5) | Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine) | Posted | Geometric Mean | 95% Confidence Interval | titers | 4 months post dose 3 |
|
|
|
| Other Pre-specified | Geometric Mean Titers (GMTs) for Anti-CS Antibodies up to Month 12 by Vaccine Group PIII (M12) | Geometric mean titers (GMTs) for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12) | Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine) | Posted | Geometric Mean | 95% Confidence Interval | titers | 10 months post dose 3 |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PRE | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination | The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titers | PRE |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PII (D60) | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60) | The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titers | post dose 2 (day 60) |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (D90) | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titers | post dose 3 (day 90) |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titers (GMTs) for Anti-CS Antibodies by Infection Status PIII (M6.5) | Geometric mean antibody titers (GMTs) for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5) | The ATP Cohort includes all evaluable subjects for whom data were available. For GMTs by infection status arms have been combined. | Posted | Geometric Mean | 95% Confidence Interval | titers | post dose 3 (month 6.5) |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PRE | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PRE= prevaccination | Immunogenicity (ATP Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine) | Posted | Number | 95% Confidence Interval | percentage of participants | Prevaccination |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PII (D60) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3. PII(D60)= post dose 2 (day 60) | Immunogenicity (According to protocol (ATP) Cohort): 222 subjects (75 RTS,S/AS01B, 74 RTS,S/AS02A, 73 rabies vaccine) | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month post dose 2 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (D90) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(D90)= post dose 3 (day 90) | Immunogenicity (According to protocol (ATP) Cohort): 213 subjects (72 RTS,S/AS01B, 72 RTS,S/AS02A, 69 rabies vaccine) | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month post dose 3 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M6.5) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M6.5)= post dose 3 (month 6.5) | Immunogenicity (According to protocol (ATP) Cohort): 207 subjects (69 RTS,S/AS01B, 69 RTS,S/AS02A, 69 rabies vaccine) | Posted | Number | 95% Confidence Interval | percentage of participants | 4 months post dose 3 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Vaccine Group PIII (M12) | Seropositivity rates for Anti-CS antibodies accessed prevaccination, 1 month post dose 2, 1 month post dose 3, 4 months post dose 3 and 10 months post dose 3 PIII(M12)= post dose 3 (month 12) | Immunogenicity (According to protocol (ATP) Cohort): 189 subjects (61 RTS,S/AS01B, 62 RTS,S/AS02A, 66 rabies vaccine) | Posted | Number | 95% Confidence Interval | percentage of participants | 10 months post dose 3 |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Infection Status PRE | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PRE= Pre-vaccination | The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | Prevaccination |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Infection Status PII (D60) | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PII(D60)= post dose 2 (day 60) | The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | post dose 2 (day 60) |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (D90) | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(D90)= post dose 3 (day 90) | The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | post dose 3 (day 90) |
|
|
|
| Other Pre-specified | Seropositivity Rates for Anti-CS Antibodies by Infection Status PIII (M6.5) | Seropositivity rates for Anti-CS antibodies by infection status on RTS,S/AS01B and RTS,S/AS02A recipients only Seropositive: >0.5EU/mL Infection defined as P. falciparum asexual parasitemia >0 PIII(M6.5)= post dose 3 (month 6.5) | The ATP Cohort includes all evaluable subjects for whom data were available. For seropositivity rates by infection status arms have been combined. | Posted | Number | 95% Confidence Interval | percentage of participants | post dose 3 (month 6.5) |
|
|
|
| Other Pre-specified | Efficacy: Vaccine Efficacy Against P. Falciparum Infection | Number of subjects with an episode of parasitemia (first recording of infection of asexual stage falciparum parasites >0 detected by active detection of infection (ADI) or passive case detection) | Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine). | Posted | Number | participants | 14 days after dose 3 and extending for 14 weeks |
|
|
|
| Other Pre-specified | Percentage of Participants With Positive and Negative Parasite Density | Percentage of participants with positive and negative parasite density at month 6.5 | Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine). Missing subject data: S/AS01B = 4, S/AS02A = 6, Rabipur = 4 | Posted | Number | % of subjects | at month 6.5 |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titers (GMTs) of Asexual P. Falciparum Parasitemia | Geometric Mean Antibody Titers (GMTs) of Asexual P. falciparum parasitemia at Month 6.5 | Efficacy (According to protocol (ATP) Cohort): 228 subjects (74 RTS,S/AS01B, 79 RTS,S/AS02A, 75 rabies vaccine). | Posted | Geometric Mean | 95% Confidence Interval | titers | Month 6.5 |
|
|
|
| 0 |
| 85 |
| 5 |
| 85 |
| 81 |
| 85 |
| EG001 | (RTS, S/AS02A) | RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. RTS, S/AS02A: 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months. | 0 | 85 | 1 | 85 | 82 | 85 |
| EG002 | Rabipur (Rabies) Vaccine | Rabipur (Rabies) Vaccine: 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months Rabipur (Rabies) Vaccine: .0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months | 0 | 85 | 5 | 85 | 82 | 85 |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wound necrosis | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| HIV infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pulmonary tuberculosis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Trichomoniasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Peptic Ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Disseminated tuberculosis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Meningitis cryptococcal | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumocystis jiroveci pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Osteoarthritis | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Encephalitis | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint pain at other location | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Muscle aches | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anal skin tags | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anal ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bowel sounds | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhea haemorrhagic | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gingivitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Glossitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lip exfoliation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hangover | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hunger | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Inflammation | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nodule | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pitting oedema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Multiple allergies | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Amoebiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ascariasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctivitis infective | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dental caries | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysentery | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Genitourinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Giardiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gonorrhea | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Helminthic infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hookworm infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malaria | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pelvic inflammatory disease | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pulpitis dental | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Schistosomiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Septic rash | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sexually transmitted disease | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Strongyloidiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Subcutaneous abscess | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tinea capitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tinea cruris | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tinea infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Trichomoniasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Typhoid fever | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaginal candidiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wound sepsis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eye injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Face injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Neck injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mean cell volume decreased | Investigations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Balanitis | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Genital ulceration | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mammory duct ectasia | Reproductive system and breast disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Epixtaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhonchi | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash pruritis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Swelling face | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
|
| Headache |
|
| Cough |
|
| Title | Measurements |
|---|---|
|
| Fatigue |
|
| Fever (Axillary) |
|
| Gastrointestinal |
|
| Headache |
|
| Joint pain at other location |
|
| Muscle aches |
|
|
| Pericardial Effusion |
|
| Cataract |
|
| Wound Necrosis |
|
| Abscess Limb |
|
| HIV Infection |
|
| Lobar Pneumonia |
|
| Malaria |
|
| Meningitis |
|
| Pneumonia |
|
| Pulmonary Tuberculosis |
|
| Trichomoniasis |
|
| Abortion |
|
| Haemoptysis |
|
| Pleural Effusion |
|
|
| Pericardial Effusion |
|
| Cataract |
|
| Peptic Ulcer Haemorrhage |
|
| Wound Necrosis |
|
| Abscess Limb |
|
| Disseminated Tuberculosis |
|
| HIV Infection |
|
| Lobar Pneumonia |
|
| Malaria |
|
| Meningitis |
|
| Meningitis Cryptococcal |
|
| Pneumocystis Jiroveci Pheumonia |
|
| Pneumonia |
|
| Pulmonary Tuberculosis |
|
| Trichomoniasis |
|
| Osteoarthritis |
|
| Encephalitis |
|
| Abortion |
|
| Haemoptysis |
|
| Pleural Effusion |
|
| Title | Measurements |
|---|---|
|
| Hemoglobin: Day 66 |
|
| Hemoglobin: Day 90 |
|
| hemoglobin: Month 6 |
|
| Hemoglobin: Month 12 |
|
| WBC: Day 0 |
|
| WBC: Day 6 |
|
| WBC: Day 66 |
|
| WBC: Day 90 |
|
| WBC: Month 6 |
|
| WBC: Month 12 |
|
| Lymphocytes: Day 0 |
|
| Lymphocytes: Day 6 |
|
| Lymphocytes: Day 66 |
|
| Lymphocytes: Day 90 |
|
| Lymphocytes: Month 6 |
|
| Lymphocytes: Month 12 |
|
| Title | Measurements |
|---|---|
|
| Bilirubin: Day 90 |
|
| ALT: Day 0 |
|
| ALT: Day 6 |
|
| ALT: Day 90 |
|
| % of Infected |
|
|
| % of Infected: PIII(D90) |
|
|
| % of Infected: PIII(M12) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|