Clinical Trial: Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Immunogenicity and Safety of Three Tetravalent Formulations of Dengue Vaccine Candidates in Healthy Adults Aged 18 to 45 Years in the US
Brief Summary:
This is a follow up study using three different formulations for each serotype with the aim of testing immunogenicity and reactogenicity
Primary Objective:
Immunogenicity: To evaluate immunogenicity by neutralizing antibody response post dose 2.
Secondary Objectives:
Safety: To evaluate safety following three formulations of ChimeriVax™ Tetravalent Dengue Vaccine.
Immunogenicity: To describe the neutralizing antibody responses after each dose.
Detailed Summary: This is a phase II, double-blind, randomized, descriptive, multicenter study in US adult subjects. Subjects will be randomized to receive a total of three doses of ChimeriVax™ Tetravalent Dengue Vaccine from one particular formulation.
Sponsor: Sanofi
Current Primary Outcome: Neutralizing antibody titers to each of four dengue virus serotypes in 2 groups of subjects after the second vaccination [ Time Frame: 12 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Safety: Adverse events in the first 28 days after each injection and SAEs during the entire trial. Immunogenicity: Neutralizing antibody titers to each of the dengue virus serotypes for each vaccine at baseline and 30 days after vaccinations [ Time Frame: 12 Months ]
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: February 6, 2008
Date Started: April 2008
Date Completion:
Last Updated: April 12, 2016
Last Verified: September 2014
