Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSinovac Biotech Co., Ltd

About this trial

To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine

Eligibility criteria

Qualifiers

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

Treatments tested in this trial

  • Sinovac rabies vaccine

Treatment groups

912 Participants
are divided into 3 treatment groups

Sponsors and collaborators