Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial

Launched by SINOVAC BIOTECH CO., LTD · Sep 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine designed to help protect against Hand, Foot and Mouth Disease and Herpangina, which are caused by certain types of viruses. The researchers want to find out how safe the vaccine is and how well it works. The trial is divided into two parts: the first part includes healthy adults and children aged 6 months to 12 years, while the second part focuses on younger children aged 6 to 71 months. To participate, individuals must be healthy and between the ages of 6 months and 59 years, and they need to be able to understand and agree to take part in the study.

Participants in the trial can expect to receive the vaccine and will be monitored for any side effects or reactions. They will also need to attend several visits for check-ups and tests. It's important to note that certain individuals, such as those with a history of serious allergies, specific medical conditions, or who have been recently vaccinated, may not be eligible to join the study. If you're considering participation, make sure to discuss any health concerns with the study team to determine if this trial is right for you or your child.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.