A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

Enterovirus Infection Clinical Trial

Official title:

A Phase I, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine Administrated With Adjuvant AlPO4 in Health Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268787
• Other study ID #: QCR-10013
• Status: Completed
• Phase: Phase 1
• First received: December 30, 2010
• Last updated: April 15, 2015
• Start date: December 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2013
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug AdministrationTaiwan: Center for Drug EvaluationTaiwan: Department of HealthTaiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterovirus Infection
• Enterovirus Infections

Intervention

Biological:
• EV71 vaccine
Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Zhongshan Distric
Taiwan	Taipei Veterans General Hospital	Taipei	Shihlin District

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes