NCT01268787

A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Enterovirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	EV71 vaccine	Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-03-01
• Completion: 2012-09-01
• First posted: 2010-12-31
• Last updated: 2015-04-16

Locations

2 sites across 1 country: Taiwan