Clinical Trial for Batch Consistency of EV71 Vaccine
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
This trial is designed as a single-center, randomized, double-blind study. A total of 720 infants aged 6 to 35 months are selected (with 240 subjects in each age group: 6-11 months, 12-23 months, and 24-35 months). Subjects from different age groups are randomly allocated to three batch groups in a 1:1:1 ratio, and receive two doses of the EV71 vaccine from the commercial production batch on days 0 and 30. After each vaccination dose, subjects will be observed for immediate reactions for 30 minutes and for solicited adverse events for the next 7 days, as well as for unsolicited adverse events over the 30 days following vaccination. All subjects will have blood samples collected on day 0 (pre-immunization) and day 60 for serum antibody testing. Additionally, 270 subjects will be selected, for additional blood sampling at various time points: 7 days, 14 days, and 30 days after the first dose, and 7 days and 14 days after the second dose, to assess the EV71 antibody levels at different timepoints following various doses of vaccination.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Infants and young children aged 6 to 35 months.
- Able to provide legal identification.
- The guardian of the subject has the ability to understand and agrees to sign the informed consent form.
Exclusion criteria
- Previous vaccination with the EV71 vaccine.
- History of hand, foot, and mouth disease.
- History of allergies, asthma, including allergies to vaccines or vaccine components, and severe adverse reactions to vaccines, such as urticaria, difficulty breathing, angioedema, or abdominal pain.
- Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
- Autoimmune diseases or immune deficiencies/immunosuppression.
- Severe neurological disorders (epilepsy, convulsions, or seizures) or mental illness.
- History of thyroidectomy, asplenia, functional asplenia, or any condition leading to asplenia or splenectomy.
- Blood coagulation abnormalities diagnosed by a physician (such as clotting factor deficiencies, coagulopathies, platelet abnormalities) or evident bruising or bleeding disorders.
- Treatment with immunosuppressants, cytotoxic therapy, or inhaled corticosteroids within 6 months prior to enrollment (excluding corticosteroid nasal spray therapy for allergic rhinitis, or topical corticosteroid treatment for acute non-complicated dermatitis).
- Receipt of blood products within 3 months prior to vaccination with the trial vaccine.
- Receipt of other investigational vaccines within 30 days prior to vaccination with the trial vaccine.
- Receipt of live attenuated vaccines within 14 days prior to vaccination with the trial vaccine.
- Receipt of subunit or inactivated vaccines within 7 days prior to vaccination with the trial vaccine.
- Any acute illness or acute exacerbation of chronic illness within the past 7 days.
- Fever before receiving the investigational vaccine, with an axillary temperature > 37.0°C.
- Any other factors that, in the investigator's judgment, make the subject unsuitable for participation in the clinical trial.
Trial design
Primary purpose
Allocation
Interventional model
Masking
720 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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