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RSV vaccine GSK3003892A

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

RSV vaccine GSK3003892A · 1 trial · 1 indication

Phase 1 1
NCT01905215Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) VaccinesInfections, Respiratory Syncytial Virus
COMPLETED128 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines
Infections, Respiratory Syncytial VirusUnlock trial analytics

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 to 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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Frequently asked questions about RSV vaccine GSK3003892A

What is RSV vaccine GSK3003892A used for?

RSV vaccine GSK3003892A is an investigational vaccine being studied for the prevention of infections caused by Respiratory Syncytial Virus (RSV). It is being developed for use in healthy adult males aged 18 years and older. The vaccine is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes RSV vaccine GSK3003892A?

RSV vaccine GSK3003892A is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical trials to evaluate the safety, reactogenicity, and immunogenicity of this investigational RSV vaccine.

What phase is RSV vaccine GSK3003892A in?

RSV vaccine GSK3003892A is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains in early-stage clinical development.

What clinical trials is RSV vaccine GSK3003892A in?

RSV vaccine GSK3003892A has been studied in one completed Phase 1 clinical trial, identified as NCT01905215. This randomized, double-blind, placebo-controlled trial evaluated the safety, reactogenicity, and immunogenicity of the vaccine in 128 healthy adult males aged 18 years and older in Canada.

Is RSV vaccine GSK3003892A the same as GSK's other RSV vaccines?

RSV vaccine GSK3003892A is one of GSK's investigational RSV vaccines. The clinical trial NCT01905215 evaluated multiple investigational RSV vaccines from GSK Biologicals, with GSK3003892A being one of them. No alternative names for this specific vaccine have been disclosed.