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Clinical Trials associated with Bivalent enterovirus vaccine, inactivated (Vero cells)(Sinovac)A Multicenter, Randomized, Double-blind, Controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of the Bivalent Enterovirus Inactivated Vaccine (Vero Cell) in Children Aged 6 to 71 Months.
This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months.
The main questions it aims to answer are:
* The primary vaccine efficacy of the investigational vaccine against Hand, Foot, and Mouth Disease(HFMD) caused by CA16 infection compared to the control vaccine.
* The neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination.
Researchers will compare the bivalent enterovirus-inactivated vaccine (Vero cell) to the EV71-inactivated vaccine (Vero cell) to prevent HFMD and Herpangina(HA).
Participants will be randomly assigned to the trial group and the control group in a 1:1 ratio to receive two doses of the investigational vaccine or the control EV71 vaccine, with a one-month interval between doses.
/ Active, not recruitingPhase 1/2 Inactivated Bivalent Enterovirus Vaccine Phase I/II Clinical Trial: Open-Label Observation in Healthy Adults and Children, and Randomized, Double-Blind, Controlled Clinical Trial in Children
The Phase I clinical trial is divided into two parts. The first part uses an open-label design, while the second part uses a randomized, double-blind, and controlled design. The goal of this clinical trial is to evaluate the tolerability and safety of a bivalent (EV71/CA16, Enterovirus 71/Coxsackievirus A16) inactivated enterovirus vaccine (Vero cell) developed by Sinovac. The vaccine will be administered to healthy adults, children aged 6 to 12 years, and children aged 6 to 71 months.
The Phase II clinical trial will also use a randomized, double-blind, and controlled design to evaluate the safety and immunogenicity of the same bivalent inactivated enterovirus vaccine (Vero cell) developed by Sinovac. This trial will involve healthy children aged 6 to 71 months.
100 Clinical Results associated with Bivalent enterovirus vaccine, inactivated (Vero cells)(Sinovac)
100 Translational Medicine associated with Bivalent enterovirus vaccine, inactivated (Vero cells)(Sinovac)
100 Patents (Medical) associated with Bivalent enterovirus vaccine, inactivated (Vero cells)(Sinovac)
100 Deals associated with Bivalent enterovirus vaccine, inactivated (Vero cells)(Sinovac)