At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Double-blind, Randomized, Placebo-controlled, Descending Age, Dose-escalation Study of the Safety, and Immunogenicity of the Trivalent P2-VP8 Subunit Rotavirus Vaccine in Healthy South African Adults, Toddlers and Infants
In Brief
A Phase 2 clinical trial evaluating Trivalent P2-VP8 Subunit Rotavirus Vaccine and Placebo for Healthy. Completed, enrolled 618 participants across 3 sites.
Detailed Summary
This is is a study of a parenteral trivalent rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study examined the safety and immunogenicity of three dose levels of this vaccine in healthy South African adults, toddlers and infants. Progression from one dose level to another and to the next age group population was based on the assessment of safety information from the lowest dose and older age group. The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated. The primary immunogenicity hypothesis is that the trivalent P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response to at least 2 of the 3 strains in 60% or more of participants in at least one of the study groups.
Study Details
Timeline
Interventions
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).
Sodium Chloride 0.9%, USP for Injection