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.
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.
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.