A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

Phase 1

Completed

• Conditions: Enterovirus Infection
• Interventions: Biological: EV71 vaccine

• Registration Number: NCT01268787
• Lead Sponsor: National Health Research Institutes, Taiwan

Brief 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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-30
• Study First Submitted QC: 2010-12-30
• Study First Posted: 2010-12-31
• Primary Completion: 2012-03
• Study Completion: 2012-09
• Status Verified: 2013-10
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subject who is free of obvious health problems
• Able and willing to comply with the study procedure adn give written informed consent

Exclusion Criteria

• Female who is pregnant/lactating or planning to be pregnant
• Body mass index(BMI) > 35
• Oral temperature > 37.5 Celsius at the time of planned vaccination
• Subject with any abnormal laboratory results at screening
• With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
• Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
• With a history of hypersensitivity to vaccine or allergic disease
• Use of any investigational/non-registered product within 30 days prior to vaccination
• Use of immunoglobulins or any blood products within 3 months prior to vaccination
• Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EV 71 vaccine 5ug	EV71 vaccine	EV71 Vaccine 5ug
EV 71 vaccine 10ug	EV71 vaccine	EV71 vaccine 10ug

Primary Outcome Measures

Name	Time	Method
Primary endpoint	210 Days	The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose

Trial Locations

Locations (2)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Shihlin District, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Zhongshan Distric, Taiwan