A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants… (NCT05099029) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate the Efficacy, Immunogenicity and Safety of an EV71 Vaccine in Healthy Infants and Children
Taiwan3,982 participantsStarted 2018-06-27
Plain-language summary
The objectives of this study are to evaluate the EV71vaccine efficacy, immune response and safety profiles after two injections of the cell culture-based inactivated EV71 vaccine with adjuvant Al(OH)3 administrated in pediatric population aged 2 months to 6 years old.
Who can participate
Age range2 Months – 71 Months
SexALL
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Inclusion criteria
✓. Healthy children aged from 2 months to 6 years old (i.e. \>= 2 months old and \< 7 years old) at the time of first vaccination.
✓. Subject's guardians are able and willing to comply with study procedures and provide the signed informed consent.
✓. Subject is able and can comply with the requirements of the protocol.
✓. Subject with body temperature \<= 38℃.
Exclusion criteria
✕. Subject with previous known Enterovirus 71 (EV71) infection or investigational EV71 vaccination.
✕. Subject with a history of herpangina, hand-foot-mouth disease, and acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 30 days.
✕. Subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
✕. Subject under 2 years old with gestation \<34weeks or a birth weight \<2200g.
✕. History of epilepsy, seizures or non-febrile convulsions that may affect subject participation in the study in the opinion of the investigator.
✕. Severe malnutrition or dysgenopathy at the screening visit.
✕. Major congenital defects or serious chronic illness, including perinatal brain damage at the screening visit.
What they're measuring
1
The incidence rate of Hand, Foot and Mouth disease caused by EV71 after the second vaccination.
Timeframe: From 28 days after the second vaccination to two year
2
Serum neutralizing antibody titers (NT) induced by the EV71 vaccine
. Subject diagnosed of having autoimmune disease (e.g., celiac disease, type I diabetes, lupus (SLE), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (JIA), immune (or idiopathic) thrombocytopenia purpura) that may affect subject participation in the study in the opinion of the investigator.