304
Participants
Start Date
December 18, 2018
Primary Completion Date
June 19, 2020
Study Completion Date
June 19, 2020
A/H7N9
Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).
AS03
AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.
Phosphate Buffered Saline (PBS) diluent
0.006M PBS diluent for Influenza Virus Vaccine.
Emory Children's Center - Pediatric Infectious Diseases, Atlanta
University of Iowa - Vaccine Research and Education Unit, Iowa City
University of Maryland Baltimore - School of Medicine - Medicine, Baltimore
Saint Louis University - Center for Vaccine Development, St Louis
Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati
Vanderbilt University Medical Center - Infectious Diseases, Nashville
The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD), Galveston
Baylor College of Medicine - Molecular Virology and Microbiology, Houston
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases, Seattle
National Institute of Allergy and Infectious Diseases (NIAID)
NIH