Status:
RECRUITING
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
Lead Sponsor:
Sinovac Life Sciences Co., Ltd.
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
Brief Summary
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 immunogenici...
Detailed Description
The Phase II clinical trial is a randomized, double-blind, active-controlled study conducted in healthy infants to evaluate the immunogenicity and safety of the investigational vaccine. The investigat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06967272
Start Date
January 20 2025
End Date
November 15 2026
Last Update
August 22 2025
Active Locations (1)
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1
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China, 430079