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GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

Phase 1

Infections, Cytomegalovirus | Vaccine | Infectious Disease |GSK plc|Trials Updated: May 30, 2017

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2007

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A clinical trials

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A · 1 trial · 1 indication

Phase 1 1
NCT00435396Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult SubjectsInfections, Cytomegalovirus
COMPLETED40 Analytics
PHASE1COMPLETED
Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects
Infections, CytomegalovirusUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence, intensity and relationship to vaccination of solicited local and general AEs.
During a 7 days follow-up after each vaccination
Occurrence, intensity and relationship to vaccination of unsolicited AEs.
During a 31 days follow-up period after each vaccination
Occurrence and relationship to vaccination of any SAEs.
Throughout the study period
Haematological and biochemical parameters.
At months 0, 1, 2, 6, 7 12 and 24

Secondary Endpoints

Anti-gB antibody avidity in all groups;
At months 0, 1, 2, 6, 7 12 and 24
Neutralizing anti-cytomegalovirus (CMV) antibody response in all groups
At months 0, 1, 2, 6, 7, 12 and 24;
Anti-CMV tegument proteins antibody response in all groups;
At months 0, 1, 2, 6, 7, 12 and 24;
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTAL -

Interventions

NameTypeDescription
GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903ABIOLOGICALIntramuscular injection, 3 doses
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * Male between, and including, 18 and 40 years of age at the time of the first vaccination. * Written informed consent obtained from the ...

Countries:Belgium
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Frequently asked questions about GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

What is GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A?

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A is an investigational vaccine developed by GSK plc for cytomegalovirus infections. It is a recombinant vaccine candidate designed to prevent CMV infection. The vaccine has been studied in a Phase 1 clinical trial in CMV-seronegative healthy male adults.

What is GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A used for?

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A is being developed for the prevention of cytomegalovirus infections. CMV is a common virus that can cause serious complications in immunocompromised individuals and newborns. The vaccine is intended to induce immune responses against CMV in healthy adults.

Who is developing GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A?

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A 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's vaccines division, GSK Biologicals, is responsible for the development of this CMV vaccine candidate.

What phase is GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A in?

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A is in Phase 1 clinical development. It has completed one Phase 1 trial. As an investigational vaccine, it has not been approved by the FDA or any regulatory agency for commercial use.

What clinical trials is GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A in?

GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A has been evaluated in a Phase 1 clinical trial, NCT00435396, titled 'Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects.' The trial enrolled 40 participants in Belgium and is completed.