Status:
COMPLETED
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of an EV71 Vaccine
Lead Sponsor:
Medigen Vaccine Biologics Corp.
Conditions:
Enterovirus 71 Infection
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
Brief Summary
Subjects will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. A booster vaccine will be given 365 days after the first dose in subjects 2 months ...
Eligibility Criteria
Inclusion
- Healthy children and infants aged from 2 months to less than 6 years as established by medical history and clinical examination.
- The subjects' parents/guardians are able to understand and sign the ICF.
Exclusion
- Age \< 2 months or ≥ 6 years.
- For subjects \< 1 year, gestational age \< 34 weeks or birth weight \< 2200 grams.
- Has poor venous access (for subjects in sub-study only).
- Currently has a fever defined as ear/rectal temperature ≥ 38°C or axillary temperature ≥ 37.5 °C within 2 days before the time of planned vaccination.
- Has had previous known exposure to EV71 or has received EV71 vaccine.
- Has a history of herpangina or HFMD associated with enterovirus infection in the past 30 days before the date of the planned study drug vaccination.
- Has been diagnosed with a significant neurological, pulmonary, cardiovascular, hematological, hepatic, or renal disorder.
- Has a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Has used any investigational/non-registered product (including drug, vaccine, or invasive medical device) within 28 days before vaccination or plan to use during the study period.
- Has confirmed or suspected autoimmune disorder, or immunodeficiency.
- Administration of any licensed live attenuated vaccine within 14 days before or after each study vaccination (with the exceptions of live attenuated Rotavirus vaccine via oral route).
- Has used immunoglobulins or any blood products within 11 months before vaccination or plan to use during the whole study period.
- Has had immunosuppressants, cytotoxic drugs, corticosteroids (including prednisolone ≥ 0.5 mg/kg/day or equivalent), or immunomodulators taken for \> 14 days within 6 months before first vaccination or plan to use before the last scheduled study visit. (Inhaled and topical steroids are allowed).
- Has any medical or psychiatric condition, that is a contraindication to protocol participation based on the judgment of the Investigator.
Key Trial Info
Start Date :
April 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2021
Estimated Enrollment :
3061 Patients enrolled
Trial Details
Trial ID
NCT03865238
Start Date
April 23 2019
End Date
April 16 2021
Last Update
April 19 2022
Active Locations (6)
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1
Mackay Memorial Hospital, HsincChu
Hsinchu, Taiwan
2
Taichung Veteran General Hospital
Taichung, Taiwan
3
Mackay Memorial Hospital, Taipei
Taipei, Taiwan
4
National Taiwan Univeristy Hospital
Taipei, Taiwan