Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
375
0.5 mL, IM, 2 injections, Formulation 1
0.5 mL, IM, 2 injections, Formulation 2
0.5 mL, IM, 2 injections, Formulation 3
Unnamed facility
San Diego, California, United States
Unnamed facility
South Miami, Florida, United States
Unnamed facility
Springfield, Missouri, United States
Unnamed facility
Cincinnati, Ohio, United States
To provide information concerning the safety after primary administration of A/H1N1 vaccine
Time frame: 6 months post-vaccination
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0.5 mL, IM, 2 injections, Formulation 4
0.5 mL, IM, 2 injections, Formulation 5
0.5 mL, IM, 2 injections, Formulation 6
0.5 mL, IM, 2 injections, Comparator 1
0.5 mL, IM, 2 injections, Comparator 2
0.5 mL, IM, 2 injections
Unnamed facility
Cincinnati, Ohio, United States
Unnamed facility
Knoxville, Tennessee, United States