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Falciparum Malaria Protein 11 with AS01B adjuvant

Phase 1

Plasmodium Falciparum Malaria | Monoclonal antibody | Infectious Disease |GSK plc|Trials Updated: Nov 26, 2018

Falciparum Malaria Protein 11 with AS01B adjuvant development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Apr 2006

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Falciparum Malaria Protein 11 with AS01B adjuvant clinical trials

Falciparum Malaria Protein 11 with AS01B adjuvant · 1 trial · 1 indication

Phase 1 1
NCT00312663Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of AmericaPlasmodium Falciparum Malaria
COMPLETED24 Analytics
PHASE1COMPLETED
Phase I/II Trial of a Malaria Vaccine in Adults Living in the United States of America
Plasmodium Falciparum Malaria
NCT0031266324
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Study Endpoints

Primary Endpoints

Safety - Most Frequently Reported Adverse Events and Grade
30 days post vaccination

An AE was defined as any reaction, side effect, or untoward event that occurred during the course of the trial whether or not the event was considered related to the study drug or clinically significant. Grade 1: Mild Grade 2: Moderate Grade 3: Severe

Secondary Endpoints

Anti-LSA-1 Antibody Response in Titer Units on Days 0, 28, 42, and 84
Days 0, 28, 42, and 84
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
10ug dose FMP011EXPERIMENTALFalciparum Malaria Protein 11 with AS01B adjuvant
50ug dose FMP011EXPERIMENTALFalciparum Malaria Protein 11 with AS01B adjuvant

Interventions

NameTypeDescription
Falciparum Malaria Protein 11 with AS01B adjuvant.BIOLOGICALmalaria experimental vaccine
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * A male or non-pregnant female 18 to 50 years of age (inclusive) at the time of screening. * Written informed consent obtained from the subject before screening procedures. * Free of obvious health problems as established by medical history and clinical examination before enter...

Countries:United States
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