NCT02109484

Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants

Phase I/II Descending Age Double-blinded Randomized Placebo-controlled Dose Escalation Study to Examine the Safety Reactogenicity Tolerability & Immunogenicity of the P2-VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers & Infants

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 6 Weeks – 35 Months
• Healthy volunteers: Accepted

Summary

This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers. If the safety profile is deemed appropriate, the study will continue to explore the safety and immunogenicity of the vaccine in healthy South African infants. The primary safety hypothesis is that the P2-VP8 subunit rotavirus vaccine is safe and well-tolerated in healthy toddlers and infants. The primary immunogenicity hypothesis is that the P2-VP8 subunit rotavirus vaccine is immunogenic in infant participants and will induce an immune response in at least 80% of participants in at least one of the study groups.

Conditions

• Evaluation of a Rotavirus Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	P2-VP8 Subunit Vaccine 10mcg	10 mcg
BIOLOGICAL	P2-VP8 Subunit Vaccine 30 mcg	30 mcg
BIOLOGICAL	P2-VP8 Subunit Vaccine 60mcg	60 mcg
OTHER	Placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-04-10
• Last updated: 2017-12-13
• Results posted: 2017-12-13

Locations

1 site across 1 country: South Africa