Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried (NCT07357545) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried
China2,040 participantsStarted 2021-08-27
Plain-language summary
To evaluate the immunogenicity and safety of different post-exposure prophylaxis (PEP) schedules of Sinovac rabies vaccine, in comparison with a marked rabies vaccinein china, in subjects aged 10-60 years old.
Who can participate
Age range10 Years – 60 Years
SexALL
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Inclusion criteria
✓. Aged 10-60 years at enrollment;
✓. Volunteers and/or their guardians voluntarily agree to participate in the study and sign the ICF.
✓. Volunteers and their families can comply with the protocol requirements for study follow-up (no plans for long-term absence or relocation from the study area);
✓. Female volunteers are not pregnant or lactating (negative urine pregnancy test before vaccination) and have no pregnancy plan within 2 months after enrollment;
✓. Axillary temperature ≤ 37.2°C.
Exclusion criteria
✕. History of injection with rabies vaccine and specific passive immune preparations, or history of dog or other mammal bites/scratches (Category II exposure or above) within the past year;
✕. History of severe allergies requiring medical intervention from previous vaccinations; other severe allergies, such as allergic shock, angioneurotic edema, allergic purpura, local allergic necrotic reaction (Arthus reaction), severe urticaria, and angioneurotic edema;
✕. Pyrexia (axillary temperature \> 38.5°C) within 3 days before the first dose vaccination; suffering from acute or chronic infectious diseases (active tuberculosis, viral hepatitis) or in the acute exacerbation phase of any chronic disease;
✕. Having received blood/blood-related products or immunoglobulins within 3 months before the first dose vaccination; or planning to use such products within 1 month after the last dose vaccination;
✕. Having received live attenuated vaccine within 14 days or any vaccine within 7 days before the first dose vaccination;
What they're measuring
1
Seroconversion rate of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Timeframe: Day 14 after the first dose vaccination
2
Seroconversion rate of serum rabies neutralizing antibody in pre-vaccination negative subjects of each group
Timeframe: Day 42 after the first dose vaccination
3
GMC of rabies neutralizing antibodies in pre-vaccination negative subjects of each group
Timeframe: Day 14 after the first dose vaccination
✕. Any condition (e.g., splenectomy) leading to asplenia or functional asplenia;
✕. Diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressant therapy within 3 months (e.g., long-term systemic glucocorticoid use ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent);
✕. Severe congenital anomaly, autoimmune disease, genetic disease; severe heart disorder, kidney disease, diabetes, or other severe chronic disease;