A Clinical Study for Inactivated Vaccine Against EV71

Phase 2

Completed

• Conditions: Enterovirus 71 Human
• Interventions: Biological: Placebo; Biological: EV71 with adjuvant aluminium phosphate

• Registration Number: NCT02200237
• Lead Sponsor: Medigen Vaccine Biologics Corp.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2014-09
• Primary Completion: 2017-05
• Status Verified: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-15
• Last Update Posted: 2017-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Phosphate Buffer Saline with adjuvant aluminium phosphate
EV71 with adjuvant aluminium phosphate	EV71 with adjuvant aluminium phosphate	Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml

Primary Outcome Measures

Name	Time	Method
To evaluate overall safety of EV71 vaccine in children, throughout the study period	2 years after study initiation	Occurrence of overall adverse events and serious adverse events during the entire period of study.

Secondary Outcome Measures

Name	Time	Method
To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine	2 years from study initiation	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

Trial Locations

Locations (4)

Chang-Guang Memorial Hospital Lin-Kou; 🇨🇳 Taipei, Taiwan

National Taiwan University Hosptial; 🇨🇳 Taipei, Taiwan

MacKay Memorial Hospital; 🇨🇳 Taipei, Taiwan

Far Eastern Memorial Hospital; 🇨🇳 Taipei, Taiwan