About this trial
To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after post-exposure prophylaxis (PEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PEP schedule
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Populations aged ≥1 years old;
Participants and/or participants' parents/legal guardians are able to understand and sign the informed consent form (ICF) voluntarily;
Participants are able to comply with the study procedures based on the investigator's assessment;
In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);
Disqualifiers
Fever on vaccination day, with axillary temperature >37.0°C (aged ≥5 years old) or >37.3°C (aged 1~4 years old) pre-vaccination;
Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
Previous administration with rabies immunoglobulins or monoclonal antibodies;
Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
Trial design
Parallel
Treatments tested in this trial
Rabies vaccine
Biological/VaccineReceiving five doses of rabies vaccine manufactured by Sinovac using the "Essen" PEP schedule
Verorab®
Biological/VaccineReceiving five doses of marketed rabies vaccine manufactured by Sanofi using the "Essen" PEP schedule
Treatment groups
Trial outcomes
Primary outcomes
Proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL
Secondary outcomes
Geometric mean concentrations (GMCs) of RVNA titers
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Incidence of adverse reactions
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: