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GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A

Phase 1

Infections, Cytomegalovirus | 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

UNCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

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, Cytomegalovirus
NCT0043539640
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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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