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

NCT07416110 | Not Yet Recruiting Phase 3

• 1 other identifier: PRO-PVRV-sf-3005
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Rabies (Healthy Volunteers)

Keywords

rabies vaccine; serum-free; lot-to-lot consistency

Outcome Measures

Primary Outcomes (1)

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

  Day 14 after the first-dose vaccination

Secondary Outcomes (5)

• GMC of rabies neutralizing antibody

  Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination

• Seroconversion Rate of rabies neutralizing antibody

  Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination

• Incidence of adverse reactions

  Up to 30 days after the last-dose vaccination

• Incidence of serious adverse events

  Up to 30 days after the last-dose vaccination

• Seropositive Rate of rabies neutralizing antibody

  Month 3, 6, and 12 after the full-course vaccination

Study Arms (3)

Sinovac rabies vaccine - Batch 1

EXPERIMENTAL

Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 1) on Day 0,3,7,14,28

Biological: Sinovac rabies vaccine

Sinovac rabies vaccine - Batch 2

EXPERIMENTAL

Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 2) on Day 0,3,7,14,28

Biological: Sinovac rabies vaccine

Sinovac rabies vaccine - Batch 3

EXPERIMENTAL

Subjects will be randomly assigned to receive 5 doses of Sinovac rabies vaccine (Batch 3) on Day 0,3,7,14,28

Biological: Sinovac rabies vaccine

Interventions

Sinovac rabies vaccine BIOLOGICAL

Three batchs of Rabies Vaccine (Serum-free Vero Cell), Freeze-dried using five doses of PEP schedules

Sinovac rabies vaccine - Batch 1; Sinovac rabies vaccine - Batch 2; Sinovac rabies vaccine - Batch 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Presence of physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiency, coagulation disorders, platelet abnormalities);
• Systemic immunosuppressive agents or other immunomodulatory therapy for ≥14 days within the past 6 months (prednisone ≥20 mg/day or ≥2 mg/(kg·day), or equivalent), cytotoxic therapy, or planned receipt of such therapy during the study period;
• Received Immunoglobulins or other blood products within 3 months prior to receiving the investigational Vaccine, or plans to receive such treatment during the study period;
• Received other Study Drug or Vaccine within the past 30 days, or plans to receive such drug or Vaccine during the study period;
• Within 14 days prior to receiving the investigational vaccine, vaccination with a live attenuated vaccine, or within 7 days, vaccination with subunit, inactivated, or other types of vaccines.
• Currently participating in other Vaccine or drug Clinical Studies, or planning to participate in other Clinical Trials during the study period;
• Subjects with skin injuries, inflammation, ulcers, skin rash, or scars at the Vaccination site that may interfere with dosing or the observation of local reactions.

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (2)

Mianzhu Municipal Center for Disease Control and Prevention

Deyang, China

Location

Neijiang Municipal Center for Disease Control and Prevention

Neijiang, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Ting Huang

CONTACT

+86 13330993324; cocoht@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)