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RSV vaccine GSK3003892A

Phase 1

Infections, Respiratory Syncytial Virus | Monoclonal antibody | Respiratory |GSK plc|Last Updated: May 30, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment128
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01905215Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) VaccinesPHASE1 COMPLETED 128 — — Jul 22, 2013Mar 16, 2015May 30, 20173 Canada
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Study Endpoints
Primary Endpoints
Occurrence of each solicited local and general adverse event (AE)
During the 7 days (Days 0-6) follow-up period after vaccination
Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
At Day 0
Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality
At Day 60
Occurrence of any unsolicited AE
During a 30-day (Days 0-29) follow-up period after vaccination
Occurrence of any Serious Adverse Events (SAEs)
From Day 0 to Day 60
Secondary Endpoints
Humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups
At pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60)
Persistence of the humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups
At Day 180 and Day 360
Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality
At Day 180 and Day 360
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group AEXPERIMENTALSubjects in this group will receive a single dose of formulation 1 of RSV vaccine
Group BEXPERIMENTALSubjects in this group will receive a single dose of formulation 2 of RSV vaccine
Group CEXPERIMENTALSubjects in this group will receive a single dose of formulation 3 of RSV vaccine
Group DEXPERIMENTALSubjects in this group will receive a single dose of formulation 4 of RSV vaccine
Group EEXPERIMENTALSubjects in this group will receive a single dose of formulation 5 of RSV vaccine
Group FEXPERIMENTALSubjects in this group will receive a single dose of formulation 6 of RSV vaccine
Group Placebo 1PLACEBO_COMPARATORSubjects in this group will receive a single dose of placebo
Group Placebo 2PLACEBO_COMPARATORSubjects in this group will receive a single dose of placebo
Interventions
NameTypeDescription
RSV vaccine GSK3003892A (formulation 1)BIOLOGICALIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
RSV vaccine GSK3003893A (formulation 2)BIOLOGICALIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
RSV vaccine GSK3003895A (formulation 3)BIOLOGICALIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
RSV vaccine GSK3003896A (formulation 4)BIOLOGICALIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
RSV vaccine GSK3003898A (formulation 5)BIOLOGICALIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
RSV vaccine GSK3003899A (formulation 6)BIOLOGICALIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Placebo comparatorDRUGIntramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
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Eligibility Criteria
Age Range18 Years — 44 Years
SexMALE
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * A male between, and including, 18 and 44 years of age at the time of vaccination. * Healthy subjects as establis...

Countries:Canada
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