RecruitingPhase 2

PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)

China400 participantsStarted 2025-01-20

Plain-language 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 immunogenicity and safety of the investigational vaccine in healthy infants through a randomized, double-blind, active-controlled trial.

Who can participate

Age range6 Weeks – 12 Weeks

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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).

What they're measuring

Evaluate the immunogenicity of the investigational vaccine at different doses

Timeframe: 28 days after the full vaccination course

Evaluate the safety of the investigational vaccine at different dose

Timeframe: 0 day after the first dose till 42 days after the last dose

Trial details

NCT IDNCT06967272

SponsorSinovac Life Sciences Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-15

Contact for this trial

Yeqing Tong

+86-13971078410 63382251@qq.com

View on ClinicalTrials.gov More Rotavirus Gastroenteritis trials