Novavax, Inc. NVAX
today announced that enrollment has begun in a Phase 1 dose-ranging clinical
trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy
adults 60 years of age and older.
This randomized, blinded, placebo-controlled Phase 1 study will evaluate the
immunogenicity and safety of two doses of Novavax' RSV-F nanoparticle protein
micelle vaccine candidate with and without aluminum phosphate as an adjuvant.
The study is similar to the recently launched Phase 2 RSV study in women of
childbearing age but will enroll 220 adults 60 years of age and older who will
receive a single intramuscular injection of Novavax' RSV-F nanoparticle
protein micelle vaccine or placebo plus a single dose of licensed influenza
vaccine or placebo at days 0 and 28. Safety and immunogenicity will be
evaluated for up to one year.
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