PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
Recruiting now · Phase 2
Conditions studied: Rotavirus Gastroenteritis
In brief
The Phase II clinical trial of the oral hexavalent reassortant rotavirus attenuated live vaccine (Vero Cells) will be conducted in infants aged 6 to 12 weeks. This study will evaluate the immunogenicity and safety of the investigational vaccine in healthy infants through a randomized, double-blind, active-controlled trial.
Key facts
- Study ID
- NCT06967272
- Run by
- Sinovac Life Sciences Co., Ltd.
- People needed
- 400
- Starts
- 2025-01-20
- Expected to finish
- 2026-11-15
- Last updated by the study team
- 2025-08-22
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy infants aged 6 to 12 weeks.
- The legal guardian(s) is/are capable of understanding and voluntarily signing the informed consent form.
- The legal guardian(s) is/are willing and able to comply with all follow-up visits, sample collection, vaccination, and other study procedures.
- Able to provide valid legal identification documents.
You may not qualify if…
- Previous vaccination with any rotavirus vaccine.
- History of rotavirus infection.
- Gestational age <37 weeks or ≥42 weeks at birth.
- History of dystocia, neonatal asphyxia requiring resuscitation, or neurological impairment at birth.
- Known hypersensitivity to any vaccine component (e.g., urticaria, dyspnea, angioedema).
- Current diarrhea, vomiting, or other gastrointestinal disorders; gastroenteritis or any acute/chronic illness exacerbation within 7 days prior to vaccination; ongoing antibiotic/antiviral therapy.
- History of intussusception or chronic gastrointestinal diseases, including congenital malformations predisposing to intussusception (e.g., Meckel's diverticulum).
- Congenital malformations, developmental disorders, genetic defects, severe malnutrition, malignancies, or significant chronic conditions (e.g., Down syndrome, diabetes, sickle cell anemia, neurological disorders, Guillain-Barré syndrome).
- Autoimmune or immunodeficiency diseases (including but not limited to asplenia, functional asplenia, HIV infection).
- Household members with immunodeficiency/immunosuppression or undergoing/scheduled for immunosuppressive/cytotoxic therapy.
- Coagulation disorders (e.g., clotting factor deficiencies, platelet abnormalities).
- Immunosuppressive therapy for ≥14 days post-birth (prednisone ≥2mg/kg/day or equivalent), immunomodulatory/cytotoxic therapy, or planned use during the study.
- History of severe neurological/psychiatric disorders (e.g., epilepsy, non-febrile seizures, convulsions) or relevant family history.
- Postnatal administration of immunoglobulins/blood products (except hepatitis B immunoglobulin) or planned use during the study.
- Previous participation in other investigational drug/vaccine studies or planned use during this study.
- Receipt of live-attenuated vaccines within 14 days or subunit/inactivated vaccines within 7 days prior to enrollment.
- Axillary temperature ≥38.0°C within the past 3 days.
- Fever on scheduled vaccination day (axillary temperature >37.0°C; measured ≥30 minutes post-feeding).
- Currently or planning to participate in other vaccine or drug clinical trials.
- Any other factors that the investigator deems unsuitable for participation in the clinical trial.
Where it is running
- Hubei Provincial Center for Disease Control and Prevention — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.