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

Infections, Cytomegalovirus Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infections, Cytomegalovirus

• NCT number: NCT00435396
• Study type: Interventional
• Source: GlaxoSmithKline
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2007
• Completion date: August 27, 2008