Clinical Trial: Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase I, Randomized, Single-Blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of the NVGH Glycoconjugate Vaccine Against S. Typhi in Adult Subjects 18 to 40 Years of A

Brief Summary: This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome:

  • Number of Subjects Reporting Any Post Immunization Reactions [ Time Frame: During the 7-day period after vaccination ]
    Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
  • Number of Subjects Reporting Adverse Events [ Time Frame: During the 28-day period after vaccination ]
  • Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the 6-month period after vaccination ]


Original Primary Outcome: Evaluation of safety profile by measuring rates of post immunization reactions and adverse events, and incidence of serious adverse events at 28 days post-immunization. Evaluation of immunogenicity profile through ELISA, at 28 days post-immunization. [ Time Frame: 28 days ]

Current Secondary Outcome: Anti-Vi ELISA Geometric Mean Concentration (GMC) [ Time Frame: At 28 days after vaccination ]

Original Secondary Outcome: To evaluate the persistence of antibody titers and the safety of investigational NVGH Vi-CRM197 conjugate vaccine against that of the licensed Vi polysaccharide vaccine as measured by ELISA, at 6 months post-immunization. [ Time Frame: 6 months ]

Information By: Novartis

Dates:
Date Received: May 13, 2010
Date Started: May 2010
Date Completion:
Last Updated: December 16, 2013
Last Verified: December 2013