Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Protein Sciences Corporation
With
Syneos Health
Department of Health and Human Services
As the spectrum of influenza vaccines rapidly evolves to quadrivalent formulations with the intention of offering broader protection to include both lineages of influenza B strains, it is appropriate to transition Flublok from a trivalent to a quadrivalent formulation. The demonstration of non-inferior post-vaccination Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) to antigens in the Flublok Quadrivalent formulation compared to those of the matching antigens in a US - approved IIV4 is intended to support licensure of Flublok Quadrivalent for the adult population for which Flublok trivalent is currently approved. The comparison of safety and reactogenicity of Flublok Quadrivalent to that of IIV4 is expected to confirm a similar safety profile.
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Ambulatory, in good health or medically stable
Able to understand and comply with planned study procedures
Provide written informed consent
Negative urine pregnancy test within 24 hours prior to vaccination (women of child-bearing potential)
You may not be if
Prior serious or severe reaction to influenza vaccine
Known contraindication to either study vaccine
Receipt of any other influenza vaccine within 180 days prior to enrollment
Plan to receive another licensed influenza or other vaccine during the duration of this study
Receipt of any significant new diagnosis, medication (licensed or investigational), or licensed vaccine within 30 days prior to enrollment in this study
Underlying disease or therapeutic intervention that might adversely affect the immune response
Plans to participate in any investigation involving an investigational product during this study.
Pregnant, lactating or planning to become pregnant within 30 days of study vaccine.
Any clinical or social circumstance that in the opinion of the investigator could interfere with compliance with study procedures or interfere with the interpretation
Clareo Health | Safety and Immunogenicity of Flublok Quadrivalent vs IIV4 in Adults 18-49 Years of Age
