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

NCT02109484 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2017-12-13

Study results available
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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

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

Sponsors & Collaborators

  • PATH

    lead OTHER

Principal Investigators

  • Michelle Groome · SAMRC Respiratory and Meningeal Pathogen Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02109484 on ClinicalTrials.gov