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RSV vaccine GSK3003892A

Phase 1

Infections, Respiratory Syncytial Virus | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 30, 2017

RSV vaccine GSK3003892A target and mechanism

ModalityVaccine

Also known as RSV vaccine GSK3003892A (formulation 1)

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

RSV vaccine GSK3003892A clinical trials

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?

RSV vaccine GSK3003892A is an investigational vaccine developed by GSK plc for the prevention of respiratory syncytial virus (RSV) infections. It is a vaccine candidate that has been studied in a Phase 1 clinical trial. The vaccine is designed to protect against RSV, a common respiratory virus that can cause serious illness.

What is RSV vaccine GSK3003892A used for?

RSV vaccine GSK3003892A is being developed for the prevention of infections caused by respiratory syncytial virus (RSV). RSV is a major cause of respiratory illness. The vaccine is intended for use in adults, as the clinical trial enrolled male participants aged 18 years and older.

Who is developing RSV vaccine GSK3003892A?

RSV vaccine GSK3003892A is being developed by GSK plc, a global pharmaceutical company. GSK plc is listed on the New York Stock Exchange under the ticker symbol GSK. The company is responsible for the research and clinical development of this investigational RSV vaccine candidate.

What phase is RSV vaccine GSK3003892A in?

RSV vaccine GSK3003892A is in Phase 1 clinical development. The Phase 1 trial has been completed. As an investigational vaccine, it has not been approved by the FDA or any regulatory authority. Further clinical trials would be needed to establish its safety and efficacy.

What clinical trials is RSV vaccine GSK3003892A in?

RSV vaccine GSK3003892A has been evaluated in a Phase 1 clinical trial, NCT01905215, titled 'Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines.' The trial was completed and enrolled 128 participants in Canada. It was randomized, double-blind, and placebo-controlled.

Is RSV vaccine GSK3003892A the same as RSV vaccine GSK3003892A (formulation 1)?

Yes, RSV vaccine GSK3003892A is also known as RSV vaccine GSK3003892A (formulation 1). The parenthetical designation distinguishes this specific formulation from other formulations that may be studied under the same base name. Both names refer to the same investigational vaccine candidate developed by GSK plc.