Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

618

Participants

Timeline

Start Date

February 15, 2016

Primary Completion Date

September 1, 2017

Study Completion Date

December 22, 2017

Conditions
Healthy
Interventions
BIOLOGICAL

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).

BIOLOGICAL

Placebo

Sodium Chloride 0.9%, USP for Injection

Trial Locations (3)

2001

Shandukani Research Centre, Johannesburg

2013

Respiratory and Meningeal Pathogens Research Unit (RMPRU), Johannesburg

7505

Family Clinical Research Unit (FAM-CRU) Stellenbosch Univ, Stellenbosch

All Listed Sponsors
collaborator

The Emmes Company, LLC

INDUSTRY

lead

PATH

OTHER

NCT02646891 - Safety and Immunogenicity Study of Trivalent P2-VP8 Subunit Rotavirus Vaccine in Adults, Toddlers and Infants | Biotech Hunter | Biotech Hunter