Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure P… (NCT07055893) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
Pakistan390 participantsStarted 2026-03-01
Plain-language summary
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
Who can participate
Age range1 Year
SexALL
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Inclusion criteria
✓. 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);
✓. Participants were tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);
✓. Female participants aged ≥15 years old with childbearing potential were tested negative for urine pregnancy test pre-vaccination, and also need to have effective contraceptive measures in the previous 2 weeks pre-vaccination.
✓. Participants of childbearing potential and their partners are willing to take effective contraceptive measures and have no sperm or ovum donation plan from the time of signing ICF to 28 days after the last dose of vaccination;
✓. Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period
Exclusion criteria
✕. 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;
What they're measuring
1
Proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/mL
Timeframe: Day 14 and Day 28 after the first dose vaccination
✕. 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;
✕. Female participants who are currently lactating or pregnant;
✕. Known serious allergy to vaccines or vaccine ingredients, such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, or known other serious adverse reactions to vaccine;
✕. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;
✕. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);