Not Yet RecruitingPhase 3

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

China912 participantsStarted 2026-03-04

Plain-language summary

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

Who can participate

Age range18 Years – 45 Years

SexALL

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Inclusion criteria

✓. 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);
✓. Female participants of childbearing potential must voluntarily adopt effective contraception measures from the signing of the Informed Consent Form until 2 months after the last dose of the investigational Vaccine in the primary immunization series, and have no plans to donate eggs; male participants have no plans to donate sperm; female participants of childbearing potential must also have adopted effective contraception measures within 2 weeks prior to Enrollment.

Exclusion criteria

✕. 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).
✕. Known allergy to any component of the trial Vaccine, or a history of severe allergies (such as anaphylactic shock, allergic laryngeal edema, allergic purpura, severe urticarial rash, dyspnea, angioneurotic edema, etc.);
✕. Presence of autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, asplenia, functional asplenia, splenectomy);
✕. Poorly controlled chronic diseases or history of severe diseases, including but not limited to cardiovascular disorders (e.g., uncontrolled hypertension: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), metabolic diseases (e.g., poorly controlled diabetes), hematological diseases, liver and kidney diseases, digestive system diseases, respiratory system disorders, history of major organ transplantation, malignant neoplasms within the past five years, or any other diseases or physiological conditions that the investigator believes may interfere with the trial results.
✕. History of encephalopathy with significant recovered with sequelae or dysfunction, or current encephalopathy (e.g., congenital cerebral dysgenesis, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarct, brain infection, chemical drug poisoning, etc., causing brain nerve tissue injury); history of convulsions, epilepsy, mental illness or family history of mental illness, or other serious neurological diseases;

What they're measuring

Geometric Mean Concentration (GMC) of rabies neutralizing antibodies among susceptible participants (RVNA titer <0.5 IU/mL before vaccination) in each group

Timeframe: Day 14 after the first-dose vaccination

Trial details

NCT IDNCT07416110

SponsorSinovac Biotech Co., Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Ting Huang

+86 13330993324 cocoht@163.com

View on ClinicalTrials.gov More Rabies (Healthy Volunteers) trials