618
Participants
Start Date
February 15, 2016
Primary Completion Date
September 1, 2017
Study Completion Date
December 22, 2017
Trivalent P2-VP8 Subunit Rotavirus Vaccine
Manufactured and supplied by the Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility (BPF). The trivalent P2-VP8 vaccine was formulated as a sterile suspension containing a total of 360 µg of protein (120 µg of each P type) per mL adsorbed to aluminum hydroxide (1.125 mg of aluminum per mL in a phosphate buffer, pH 7).
Placebo
Sodium Chloride 0.9%, USP for Injection
Shandukani Research Centre, Johannesburg
Respiratory and Meningeal Pathogens Research Unit (RMPRU), Johannesburg
Family Clinical Research Unit (FAM-CRU) Stellenbosch Univ, Stellenbosch
The Emmes Company, LLC
INDUSTRY
PATH
OTHER