About this trial
To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants are able to understand and voluntarily sign the Informed Consent Form;
Able to provide legal identity documents;
Age 18 to 45 years;
Stable health status (defined as stable underlying disease status within 3 months prior to enrollment, i.e., no change in original treatment or hospitalization due to disorder aggravation);
Disqualifiers
For subjects with pyrexia on the scheduled vaccination day, axillary temperature >37.3℃ before vaccination;
Previous use of anti-Rabies Passive immunization preparations (including but not limited to equine-derived Immunoglobulin ERIG, human-derived Immunoglobulins HRIG, and rabies monoclonal antibody preparations, etc.) or previous Vaccination with human Rabies Vaccine;
Individuals with mammalian animal bites/scratches (e.g., dog/cat) and broken skin (i.e., Category II or higher exposure) within the past year.;
Female participants who are lactating or pregnant (including those with a positive urine pregnancy test).
Trial design
Parallel
Treatments tested in this trial
Sinovac rabies vaccine
Biological/VaccineThree batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules
Treatment groups
Trial outcomes
Primary outcomes
Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group
Secondary outcomes
GMC of rabies neutralizing antibody
Seroconversion Rate of rabies neutralizing antibody
Incidence of adverse reactions
Incidence of serious adverse events
Sponsors and contacts
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