The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells) (NCT06950645) | Clinical Trial Compass
CompletedPhase 1
The Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
China100 participantsStarted 2024-03-27
Plain-language summary
The Phase I clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in a population ranging from 6 weeks to 59 years of age.
The objective of this study is to evaluate the safety of investigational vaccine in healthy adults and children, as well as its safety tolerability, and immunogenicity in healthy infants.
The study will be an open-label observation in adults and children, and a randomized, double-blind, placebo-controlled clinical trial in infants.
Who can participate
Age range6 Weeks – 59 Years
SexALL
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Inclusion criteria
✓. The participant and/or their guardian is willing and able to comply with all study procedures, sign the informed consent form, and remain contactable throughout the study period.
✓. Provide legal identification.
✓. Male or female, aged 6 to 12 weeks, or 2 to 6 years, or 18 to 59 years, and in good health.
✓. Fertile participants have no plans for pregnancy from the time of signing the informed consent form until 3 months after the last dose of the study vaccine and agree to use effective contraception, and have no plans for sperm or egg donation.
Exclusion criteria
✕. Known allergy to the vaccine or its components, such as urticaria, dyspnea, angioedema, etc.
✕. Current diarrhea or vomiting, or other gastrointestinal diseases, or having experienced gastroenteritis or any acute illness or acute exacerbation of chronic disease within the past 7 days, or those currently using antibiotics or antiviral therapy.
✕. History of intussusception or chronic gastrointestinal disease, including gastrointestinal congenital anomalies that can easily cause intussusception (e.g., Meckel's diverticulum).
✕. Presence of autoimmune diseases or immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid disease, asplenia, functional asplenia, HIV infection).
✕. Household members living with the participant are in an immunodeficient or immunosuppressed state or are currently/soon to be receiving immunosuppressive therapy, cytotoxic therapy, etc.
✕. Presence of coagulation dysfunction (such as deficiency of coagulation factors, abnormal platelets).
✕. Received \>14 days of immunosuppressive therapy or other immunomodulatory therapy, cytotoxic therapy within the past 6 months (for adult and pediatric participants) or since birth (for infant participants), or planned to receive such treatment during the study period.