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.
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 investigational vaccine is available in both high-dose and low-dose formulations. The control vaccine is the orally administered pentavalent reassortant rotavirus attenuated live vaccine (Vero Cells) produced by Merck Sharp \& Dohme Corp. This study plans to recruit 400 infants aged 6 to 12 weeks. All participants will be randomly assigned to the low-dose investigational group, high-dose investigational group, and active-controlled group, respectively.The immunization schedule for both the investigational vaccine and controlled vaccine consists of three doses administered at 28-day intervals. Blood samples will be collected at predefined time points to evaluate the immunogenicity of the investigational vaccine. Adverse events (AEs) will be collected for all participants from the first vaccination until 42 days after the last dose, while serious adverse events (SAEs) and adverse events of special interest (AESIs) will be monitored for 12 months. A safety monitoring sub-cohort will be established, with stool samples collected daily for 14 days after each vaccination to assess vaccine virus shedding, duration and patterns of viral shedding, potential reassortment and reversion to virulence of the rotavirus vaccine strains
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
400
Oral hexavalent reassortant rotavirus attenuated live vaccine (low-dose) three doses administered orally
Oral hexavalent reassortant rotavirus attenuated live vaccine (high-dose) three doses administered orally
The controlled vaccine three doses administered orally
Hubei Provincial Center for Disease Control and Prevention
Wuhan, Hubei, China
RECRUITINGEvaluate the immunogenicity of the investigational vaccine at different doses
The seroconversion rate of IgA antibodies against vaccine-type rotavirus in serum
Time frame: 28 days after the full vaccination course
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Time frame: 0 day after the first dose till 42 days after the last dose
Evaluate the immunogenicity of the investigational vaccine at different doses
The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity of the investigational vaccine at different doses
The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity of the investigational vaccine at different doses
The geometric mean increase (GMI) of serum anti-vaccine-type rotavirus IgA antibodies
Time frame: 28 days after the full vaccination course
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
The geometric mean concentration (GMC) of serum anti-vaccine-type rotavirus IgA antibodies
Time frame: 12 months after the full vaccination course
Evaluate the immunogenicity persistence of the investigational vaccine at different doses
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The positivity rate of serum anti-vaccine-type rotavirus IgA antibodies
Time frame: 12 months after the full vaccination course
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Time frame: 0-30 minutes after each dose
Evaluate the safety of the investigational vaccine at different dose
Incidence of adverse events/reactions
Time frame: 0-14 days after each dose
Evaluate the safety of the investigational vaccine at different dose
Incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs)
Time frame: The first dose to 12 months after full vaccination
Evaluate the fecal shedding of investigated vaccine strain after vaccination
The shedding rate of the rotavirus vaccine strain in the stool.
Time frame: 0-14 days after each dose
Evaluate the fecal shedding of investigated vaccine strain after vaccination
The shedding duration of the rotavirus vaccine strain in the stool.
Time frame: 0-14 days after each dose
Evaluate the reassortment and reversion of the rotavirus vaccine strain in stool samples after vaccination
The incidence of reassortment and reversion of the rotavirus vaccine strain in stool samples.
Time frame: 0-14 days after each dose