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 range
6 Weeks – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the safety of the investigational vaccine
Timeframe: 0 day after the first dose till 42 days after the last dose
. 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).
. For infant and pediatric participants: congenital malformations or developmental disabilities, genetic defect diseases, severe malnutrition, or severe chronic diseases (such as Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome); For adult participants: uncontrolled chronic diseases or severe disease history, including but not limited to cardiovascular diseases (such as drug-uncontrolled hypertension, i.e., systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), hematologic diseases, hepatic and renal diseases, gastrointestinal diseases, respiratory diseases, malignant tumors, history of major organ transplantation, or any other disease or medical condition that the investigator believes may interfere with the trial results.
. 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.