NCT01268787

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 16, 2015

Status Verified

October 1, 2013

Enrollment Period

1.2 years

First QC Date

December 30, 2010

Last Update Submit

April 15, 2015

Conditions

Enterovirus Infection

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint

    The percentage, intensity and relationship to vaccination of local and systemic signs and symptoms at a 0.25ml and 0.5ml dose

    210 Days

Study Arms (2)

EV 71 vaccine 5ug

ACTIVE COMPARATOR

EV71 Vaccine 5ug

Biological: EV71 vaccine

EV 71 vaccine 10ug

EXPERIMENTAL

EV71 vaccine 10ug

Biological: EV71 vaccine

Interventions

EV71 vaccineBIOLOGICAL

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

Also known as: EV71 vac
EV 71 vaccine 10ugEV 71 vaccine 5ug

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Taipei Veterans General Hospital

Taipei, Shihlin District, 112, Taiwan

Location

National Taiwan University Hospital

Taipei, Zhongshan Distric, 104, Taiwan

Location

Related Publications (2)

  • Chou AH, Liu CC, Chang JY, Jiang R, Hsieh YC, Tsao A, Wu CL, Huang JL, Fung CP, Hsieh SM, Wang YF, Wang JR, Hu MH, Chiang JR, Su IJ, Chong PC. Formalin-inactivated EV71 vaccine candidate induced cross-neutralizing antibody against subgenotypes B1, B4, B5 and C4A in adult volunteers. PLoS One. 2013 Nov 21;8(11):e79783. doi: 10.1371/journal.pone.0079783. eCollection 2013.

    PMID: 24278177DERIVED

  • Cheng A, Fung CP, Liu CC, Lin YT, Tsai HY, Chang SC, Chou AH, Chang JY, Jiang RH, Hsieh YC, Su IJ, Chong PC, Hsieh SM. A Phase I, randomized, open-label study to evaluate the safety and immunogenicity of an enterovirus 71 vaccine. Vaccine. 2013 May 7;31(20):2471-6. doi: 10.1016/j.vaccine.2013.03.015. Epub 2013 Mar 27.

    PMID: 23541623DERIVED

MeSH Terms

Conditions

Enterovirus Infections

Condition Hierarchy (Ancestors)

Picornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Pele Chong, Ph.D.

    National Health Research Institutes, Taiwan

    STUDY CHAIR

  • Chia-Chyi Liu, Ph.D.

    National Health Research Institutes, Taiwan

    STUDY DIRECTOR

  • C P Fung, M.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

  • S M Hsieh, M.D

    Taipei Meidcal College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2010

First Posted

December 31, 2010

Study Start

December 1, 2010

Primary Completion

March 1, 2012

Study Completion

September 1, 2012

Last Updated

April 16, 2015

Record last verified: 2013-10

Locations

TW(2)