A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

National Health Research Institutes, Taiwan

Status and phase

Completed

Phase 1

Conditions

Enterovirus Infection

Treatments

Biological: EV71 vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT01268787

QCR-10013

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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