Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-71
SponsorSinovac Biotech Co., Ltd
About this trial
This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.
Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
Eligibility criteria
Qualifiers
Healthy children aged 6 to 71 months.
Guardians who can understand and voluntarily sign the informed consent form
Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。
Provide legal identification for the participant and their guardian
Disqualifiers
A known history of HFMD/HA
Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation.
Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
Abnormal coagulation function (such as coagulation factor deficiencies,and platelet abnormalities).
Trial design
Treatments tested in this trial
- Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)
- Placebo
Treatment groups
6,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov