A Clinical Study for Inactivated Vaccine Against EV71

Enterovirus 71 Human Clinical Trial

— EV71  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200237
• Other study ID #: CT-EV-21
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2014
• Last updated: August 15, 2017
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: Medigen Vaccine Biologics Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in health children and infants aged from 2 months to <12yrs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: August 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 12 Years

Eligibility

Main Inclusion Criteria:

1. Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination

2. The subjects' guardians are able to understand and sign the informed consent

Main Exclusion Criteria:

1. Subject with previous known exposure to EV71.

2. Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.

3. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.

4. Use of any investigational/non-registered product (including drug, vaccine and invasive medical device) within 30 days prior to vaccination or planned use during study period.

5. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency

6. Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.

Related Conditions & MeSH terms

• Enterovirus 71 Human
• Enterovirus Infections

Intervention

Biological:
• EV71 with adjuvant aluminium phosphate
Two arms, EV71 with aluminium phosphate
• Placebo
Phosphate Buffer Saline with adjuvant aluminium phosphate

Locations

Country	Name	City	State
Taiwan	Chang-Guang Memorial Hospital Lin-Kou	Taipei
Taiwan	Far Eastern Memorial Hospital	Taipei
Taiwan	MacKay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hosptial	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Medigen Vaccine Biologics Corp.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate overall safety of EV71 vaccine in children, throughout the study period	Occurrence of overall adverse events and serious adverse events during the entire period of study.	2 years after study initiation
Secondary	To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine	To evaluate the immunogencity in terms of; Geometric mean titer (GMT) of EV71 neutralizing antibody titers; Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers; Seropositivity rate	2 years from study initiation