A Clinical Study for Inactivated Vaccine Against EV71
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 365
Inclusion Criteria
- 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
- The subjects' guardians are able to understand and sign the informed consent
Exclusion Criteria
- Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- 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 a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- 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 any confirmed or suspected autoimmune disorder, or immunodeficiency
- Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
- Subject with previous known exposure to EV71.
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
- 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
- The subjects' guardians are able to understand and sign the informed consent
Exclusion Criteria
- Subject with a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- 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 a history of herpangina or hand, foot and mouth disease associated with enterovirus infection in the past 3 months.
- 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 any confirmed or suspected autoimmune disorder, or immunodeficiency
- Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder.
- Subject with previous known exposure to EV71.
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