Overview
The purpose of this study is to assess the immunogenicity and safety of EV71 vaccine (Envacgen®) in Children Aged 6 to <10 Years compared to Children Aged 2 to <6 Years.
Description
This is a prospective, open-label, multi-center, phase 3 study. Participants will receive the first IM injection of study vaccine on Day 1 and will receive a second dose 56 days later. The last study visit is on Day 237 when participants will be contacted via telephone to assess for adverse events .
Eligibility
Inclusion Criteria:
- Healthy children aged 2 to <10 years as established by medical history and clinical examination.
- Subject and/or the subject's parent/guardian is able to understand and sign the ICF.
Exclusion Criteria:
- Has poor venous access.
- 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 previously known exposure to EV71 or has received EV71 vaccine.
- Has a history of herpangina or HFMD associated with enterovirus infection in the past 28 days before the date of 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 or any residual trace components such as formaldehyde of the Envacgen® vaccine.
- Has used any investigational/nonregistered product (including drug, vaccine, or invasive medical device) within 28 days before study vaccination or plans to use any of them during the study period.
- Has confirmed or suspected autoimmune disorder or immunodeficiency.
- Has been administered or plans to be administered with any licensed live attenuated vaccine within 14 days before or after each study vaccination.
- Has used immunoglobulins via intravenous route or any blood products within 11 months before vaccination or plans to use any of them during the study period.
- Has received immunosuppressant, cytotoxic drug, corticosteroid (including prednisolone ≥ 0.5 mg/kg/day or equivalent), immunomodulator or acetylsalicylic acid for > 14 days within 6 months before the first vaccination or plans to use any of them during the study period. (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.