Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00666380 | A Study to Determine the Effects of an Investigational Malaria Vaccine Given to Adults Living in the United States and Thereafter to Adults Living in Kenya | PHASE1 | COMPLETED | 26 | — | — | Apr 1, 2008 | Jun 1, 2009 | May 29, 2015 | 2 | United States, Kenya |
Occurrence and intensity of solicited symptoms on day of vaccination and Days 1-7 after each vaccination
Occurrence and intensity of unsolicited symptoms over a 30-day follow-up period (day of vaccination and 29 subsequent days) after each vaccination
| Arm | Type | Description |
|---|---|---|
| 10 ug of FMP010 antigen in 0.5 mL AS01B adjuvant | EXPERIMENTAL | - |
| 50 ug of FMP010 antigen in 0.5 mL AS01B adjuvant | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Plasmodium falciparum Malaria Protein 010 (FMP010) | BIOLOGICAL | Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK |
Inclusion Criteria: * A male or non-pregnant, non-lactating female 18 to 50 years of age (inclusive) at the time of screening * Free of significant health problems as established by medical history and clinical examination before entering into the study * Available to participate for duration of st...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 4 | PHASE3 | Tafenoquine, Primaquine, Chloroquine, GSK3772701, RTS,S/AS01E vaccine |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | INE963, KAE609, KLU156 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |