Status:
UNKNOWN
Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial
Lead Sponsor:
Sinovac Biotech Co., Ltd
Conditions:
Hand, Foot and Mouth Disease
Herpangina
Eligibility:
All Genders
6-59 years
Phase:
PHASE1
PHASE2
Brief Summary
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design. The goal of this clinical ...
Detailed Description
For phase I clinical trial: The first part of the trial plans to recruit thirty-six healthy adults aged 18-59 years and thirty-six children aged 6-12 years, with twelve participants in each of the lo...
Eligibility Criteria
Inclusion
- Healthy participants aged 18-59 years, 6-12 years, and 6-71 months.
- Participants and/or their guardians can understand and voluntarily sign the informed consent form (participants aged 8-12 years require dual signatures from both participants and their guardians).
- Willing and able to comply with all visit schedules, sample collection, vaccine administration, and other trial procedures.
- Provide legal identification of the participants and/or their guardians.
Exclusion
- History of hand, foot, and mouth disease or EV71 vaccination.
- Known severe allergy to the vaccine or vaccine components, such as urticaria, respiratory distress, and angioedema.
- Congenital abnormalities or developmental disorders, genetic defects (such as Down syndrome, thalassemia, or G6PD deficiency), severe malnutrition, etc.
- Based on medical history and physical examination, the presence of severe chronic diseases, severe cardiovascular diseases, uncontrolled hypertension or diabetes, liver or kidney diseases, etc.
- Based on medical history and physical examination, the presence of autoimmune diseases, immunodeficiency diseases, and/or blood diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, thyroidectomy, autoimmune thyroid disease, any form of malignancy, asplenia, functional asplenia).
- Based on medical history and physical examination, abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or obvious bruising or bleeding disorders.
- Based on medical history and physical examination, the presence of severe neurological diseases (epilepsy, convulsions, or seizures), mental illness, or corresponding family history.
- Long-term use (more than 14 days) of corticosteroids or other immunosuppressive agents (excluding corticosteroid sprays for allergic rhinitis and surface corticosteroid treatment for acute non-complicated dermatitis) or cytotoxic therapy or planning to receive such treatment during the trial.
- History of long-term alcohol abuse or drug abuse.
- Females who are breastfeeding, pregnant, or planning to become pregnant within 90 days, or females with positive pregnancy test results. Note: male participants whose spouse plans to become pregnant within 90 days are also included.
- Received immunoglobulin and/or other blood products in the past 3 months or planning to receive such treatment during the trial.
- Received other investigational drugs or vaccines within the past 30 days or planning to receive such drugs or vaccines during the trial.
- Vaccinated with attenuated live vaccines within the past 14 days or subunit or inactivated vaccines within the past 7 days.
- Suspected or confirmed fever within 72 hours before vaccination or axillary temperature \>37.0℃ on the day of vaccination.
- Clinical laboratory testing shows laboratory abnormalities beyond the reference range and with clinical significance (applicable only to Phase I clinical trials for adults/6-12-year-old children/24-71-month-old children):
- A. Complete blood count: white blood cell count, hemoglobin, platelet count.B. Blood biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), creatinine (CR), fasting blood glucose (Glu).C. Urine routine: urine protein (PRO).
- Any acute illness (with or without fever) or exacerbation of chronic illness within the past 7 days.
- According to the investigator's judgment, there are any other factors that make the participant unsuitable for participation in the clinical trial.
Key Trial Info
Start Date :
September 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2025
Estimated Enrollment :
744 Patients enrolled
Trial Details
Trial ID
NCT06063057
Start Date
September 20 2023
End Date
April 10 2025
Last Update
October 2 2023
Active Locations (1)
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1
Dayao County Center for Disease Control and Prevention
Chuxiong, Yunnan, China