NCT00435396

Study to Evaluate Safety and Immunogenicity of the GSK Bio CMV Vaccine in CMV-seronegative Healthy Male Adult Subjects

A Phase I, Open-label, Vaccination Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals Recombinant CMV gB Sub-unit Vaccine GSK1492903A in CMV-seronegative Healthy Male Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This will be the first time in humans (FTIH) study with the GSK Bio recombinant gB antigen to evaluate safety and immunogenicity of this CMV candidate vaccine with a proprietary GSK adjuvant system. The vaccine will be administered to young male healthy subjects at 0, 1 and 6 months. The trial will assess the safety and immunogenicity of the candidate CMV vaccine. An additional secondary objective of this trial is to identify and validate a test which will be able to differentiate between previous CMV infection and CMV vaccination. Subjects will be followed for a total of 2 years.

Detailed description

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol. The section impacted by the change is Key inclusion \& exclusion criteria. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Infections, Cytomegalovirus

Interventions

Type	Name	Description
BIOLOGICAL	GSK Biologicals' Recombinant CMV gB Vaccine GSK1492903A	Intramuscular injection, 3 doses

Timeline

• Start date: 2007-02-22
• Primary completion: 2008-08-27
• Completion: 2008-08-27
• First posted: 2007-02-15
• Last updated: 2017-05-30

Locations

2 sites across 1 country: Belgium