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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01268787

Enrollment

Registered

2010-12-31

Start date

2010-12-31

Completion date

2012-09-30

Last updated

2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enterovirus Infection

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.

Interventions

BIOLOGICALEV71 vaccine

Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026