A Clinical Study for Inactivated Vaccine Against EV71
EV71
1 other identifier
interventional
366
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2014
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2014
CompletedFirst Posted
Study publicly available on registry
July 25, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 18, 2017
August 1, 2017
2.7 years
July 18, 2014
August 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
2 years from study initiation
Study Arms (2)
Placebo
PLACEBO COMPARATORPhosphate Buffer Saline with adjuvant aluminium phosphate
EV71 with adjuvant aluminium phosphate
EXPERIMENTALInactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml
Interventions
Two arms, EV71 with aluminium phosphate
Eligibility Criteria
You may qualify if:
- Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
You may not qualify if:
- Subject with previous known exposure to EV71.
- Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
- 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.
- Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
- Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Chang-Guang Memorial Hospital Lin-Kou
Taipei, Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
National Taiwan University Hosptial
Taipei, Taiwan
Study Officials
- PRINCIPAL INVESTIGATOR
Li-Min Huang, M.D., PhD.
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2014
First Posted
July 25, 2014
Study Start
September 1, 2014
Primary Completion
May 1, 2017
Study Completion
August 1, 2017
Last Updated
August 18, 2017
Record last verified: 2017-08