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.
Parallel
Oral hexavalent reassortant rotavirus attenuated live vaccine
Biological/VaccineOral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccine
Biological/VaccineOral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
Oral pentavalent reassortant rotavirus attenuated live vaccine (controlled)
Biological/VaccineThe controlled vaccine three doses administered orally
Evaluate the immunogenicity of the investigational vaccine at different doses
The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Evaluate the immunogenicity of the investigational vaccine at different doses
The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies
Evaluate the immunogenicity of the investigational vaccine at different doses
The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies
Evaluate the immunogenicity of the investigational vaccine at different doses
The geometric mean increase (GMI) of serum anti-vaccine-type rotavirus IgA antibodies
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies
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