This study is a randomized, blinded study to evaluate the lot-to-lot consistency of immunogenicity, safety, and immune persistence of three consecutive manufacturing lots of EV71 vaccine, in 1500 children aged 6-35 months. The primary immunogenicity endpoint is the anti-EV71 neutralizing antibody geometric mean titer (GMT) 30 days after the final dose. The secondary immunogenicity endpoints are the geometric mean fold increases and seroconversion rates of anti-EV71 neutralizing antibodies 30 days after the final dose. The immune persistence endpoints are the seropositive rates as well as GMT of anti-EV71 neutralizing antibodies 12 and 24 months after the final dose. The safety endpoints are the number of adverse events/reactions within 30 minutes after each dose, the number of solicited adverse events/reactions within 7 days after each dose, the number of unsolicited adverse events/reactions within 30 days after each dose, and the number of serious adverse events (SAE) from the first dose to 6 months post the final dose.
Age Requirement: Children aged 6 to 35 months at the time of enrollment.
Provision of legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
Informed Consent: Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements and complete relevant visits on time.
Temperature Requirement: Axillary body temperature prior to vaccination is less than 37.3°C.
Allergic History: Subjects have a previous history of allergies to any component of the vaccine (e.g., aluminum hydroxide, glycine), or previous or suspected allergy to any vaccine or other serious adverse reaction (e.g., anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.).
Vaccination History: Subjects received any inactivated vaccine or subunit vaccine within 7 days prior to the first dose of the investigational vaccine or any live attenuated vaccine within 14 days prior to the first dose of the investigational vaccine.
Neurological and Mental Health: Subjects with a history or family history of convulsion, epilepsy, encephalopathy, and psychosis.
Health Conditions: Subjects with known severe congenital malformation or developmental disorder (e.g., Down syndrome, sickle cell anemia, congenital neurological disorders).
Parallel
EV71 Vaccine
Biological/VaccineInactivated enterovirus 71 vaccine (human diploid cell) of 3.0EU/0.5mL on Day 0,30
Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
Immunogenicity index-geometric mean fold increase (GMFI) of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method
Immunogenicity index-seroconversion rates of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or ≥4-fold increase from baseline
Immunogenicity index-seropositive rates of neutralizing antibody
Neutralizing antibody assay will be performed using the neutralization and Microneutralization test method. Seropositive will be defined as the positive results with ties≥1:8
Safety index-incidence of adverse reactions/events
Incidence of adverse reactions/events after the first dose vaccination
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Institute of Medical Biology, Chinese Academy of Medical Sciences
Lead sponsor
Centers for Disease Control and Prevention, China
Collaborator
