Clinical Trial: Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomised, Double-Blind, Placebo-Controlled, Single Dose, Dose Escalation Study to Determine the Immunogenicity, Safety and Tolerability of S. Typhi (Ty2 aroC‾ssaV‾) ZH9 at Doses of 5.0
Brief Summary: This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility. The vaccine will be delivered as a single oral dose to healthy, typhoid vaccine-naïve adults.
Detailed Summary:
Sponsor: Emergent BioSolutions
Current Primary Outcome:
- Safety (including the proportion of subjects reporting adverse events (AEs) and serious adverse events (SAEs)). [ Time Frame: From day of dosing to 28 days post-dosing under double-blind conditions with 3 month open follow-up ]
- Immunogenicity (level of IgG and IgA antibodies for Salmonella typhi lipopolysaccharide post-dosing, in comparison to baseline levels). [ Time Frame: Days 7, 14 and 28 post-dosing ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Immunogenicity (Number of cells secreting IgA antibodies for Salmonella typhi lipopolysaccharide) [ Time Frame: Day 7 post-dosing ]
Original Secondary Outcome: Same as current
Information By: Emergent BioSolutions
Dates:
Date Received: May 14, 2008
Date Started: May 2008
Date Completion:
Last Updated: January 30, 2009
Last Verified: January 2009
