Recruitment

Recruitment Status
Completed
Estimated Enrollment
365

Inclusion Criteria

The subjects' guardians are able to understand and sign the informed consent
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
Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination

Exclusion Criteria

Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Subject with previous known exposure to EV71.
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.
...
Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Subject with previous known exposure to EV71.
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 who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.

Summary

Conditions
Enterovirus 71 Human
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Prevention

Participation Requirements

Age
Younger than 212 years
Gender
Both males and females

Inclusion Criteria

The subjects' guardians are able to understand and sign the informed consent
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
Healthy children and infants aged from 2 months to less than 12 years as established by medical history and clinical examination

Exclusion Criteria

Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Subject with previous known exposure to EV71.
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.
...
Use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the whole study period.
Subject with previous known exposure to EV71.
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 who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency
Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.

Tracking Information

NCT #
NCT02200237
Collaborators
Not Provided
Investigators
  • Principal Investigator: Li-Min Huang, M.D., PhD. National Taiwan University Hospital
  • Li-Min Huang, M.D., PhD. National Taiwan University Hospital
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