Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine
NCT07416110
Phase
Phase 3
Recruitment status
Not yet recruiting
Participants
Lead sponsor
Sinovac Biotech Co., Ltd
Start date
2026-03-04
Number of sites
- Summary
- To evaluate immunogenicity consistency between three consecutive batches of commercial-scale productions for Sinovac Rabies vaccine
- Short title
- Phase IIIb Clinical Trial to Evaluate Lot-to-lot Consistency of Sinovac Rabies Vaccine
- Official title
- Lot-to-lot Consistency and Safety of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried in Healthy Individuals Aged 18-45 Years: A Randomized, Double-Blind Phase IIIb Clinical Trial
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-06-30
- First posted
- 2026-02-17
- Registry last updated
- 2026-02-17
- Primary completion date
- 2026-09-30
- Start date
- 2026-03-04
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- 1:1:1
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07416110
- ClinicalTrials.gov ID
- NCT07416110
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masking description
- Double-blind
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
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
GMC of rabies neutralizing antibody
Timeframe: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Seroconversion Rate of rabies neutralizing antibody
Timeframe: Day 14 after the first-dose vaccination and at Day 14 after the full-course vaccination
Incidence of adverse reactions
Timeframe: Up to 30 days after the last-dose vaccination
Incidence of serious adverse events
Timeframe: Up to 30 days after the last-dose vaccination
Seropositive Rate of rabies neutralizing antibody
Timeframe: Month 3, 6, and 12 after the full-course vaccination
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Within 3 days prior to vaccination, any acute disease or acute exacerbation of a chronic disease, or known or suspected active infection;
- Based on the Investigator's judgment, the participant has any other discomfort or factors suitable for participating in the clinical trial.
Sources for eligibility
- Mianzhu Municipal Center for Disease Control and PreventionDeyang, China
- Neijiang Municipal Center for Disease Control and PreventionNeijiang, China
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Rabies Primary condition