Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)
ConditionRabies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-59
SponsorSinovac Biotech Co., Ltd
About this trial
To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.
Eligibility criteria
Qualifiers
Populations aged 18~59 years old;
Participants 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);
Disqualifiers
Fever on vaccination day, with axillary temperature >37.0°C pre-vaccination;
Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
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;
Trial design
Treatments tested in this trial
- Rabies Vaccine (Serum-free Vero Cell), Freeze-dried
- Verorab®
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov