Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:13 AM
Ignite Modification Date:
2025-12-25 @ 1:13 AM
NCT ID:
NCT07055893
Brief 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
Detailed Description:
This is a Phase Ⅲ, randomized, double-blind, active-controlled study. A total of 390 healthy participants aged ≥1 years old will be enrolled. All participants will be randomized at a 2:1 ratio to receive Sinovac rabies vaccine (Trial group) or Sanofi Pasteur Verorab® (Control group), in an Essen schedule of 5 doses at Day 0, Day 3, Day 7, Day 14, Day 28 through intramuscular route (IM) as a simulated rabies PEP.
Blood samples for immunogenicity assessment will be collected at Day 0, Day 14, Day 28, and Day 42. For safety assessment, the solicited local and systemic adverse events (AEs) within 7 days after each-dose vaccination (If the vaccination interval is less than 7 days, the actual interval shall prevail), as well as unsolicited AEs from the first-dose vaccination until 28 days after the last-dose vaccination will be actively monitored. Serious adverse events (SAEs) will also be collected during the whole study period.
Study:
NCT07055893
Study Brief:
Protocol Section:
NCT07055893