A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

Enterovirus Infection Clinical Trial

Official title: A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers

Status Completed

Clinical Trial Summary

This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers

Clinical Trial Description

This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterovirus Infection
• Enterovirus Infections

• NCT number: NCT01268787
• Study type: Interventional
• Source: National Health Research Institutes, Taiwan
• Status: Completed
• Phase: Phase 1
• Start date: December 2010
• Completion date: September 2012