Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2026-01-01 @ 3:59 AM
Study NCT ID:
NCT07055295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Pre-exposure Prophylaxis Regimen
Sponsor:
Sinovac Biotech Co., Ltd
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of a Rabies Vaccine (Serum-free Vero Cell), Freeze-dried in Comparison With Verorab®, in a Pre-exposure Prophylaxis Regimen in Healthy Populations Aged ≥1 Years: A Randomized, Double-Blind, Active-controlled Phase Ⅲ Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To demonstrate the immunogenicity of Sinovac rabies vaccine is non-inferior to the active-controlled rabies vaccine (Verorab®) after pre-exposure prophylaxis (PrEP) vaccination, and to confirm its satisfying safety profile in the pediatric and adult population in a PrEP 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 a three doses of PrEP schedule at Day 0, Day 7 and Day 28 through intramuscular route (IM) that covers a two doses of IM PrEP schedule at Day 0, Day 7 as well.
Blood samples for immunogenicity assessment will be collected at Day 0, Day 28, and Day 42. For immunogenicity assessment, the blood sample at Day 28 will be used for the two-doses IM PrEP schedule, and the blood sample at Day 42 will be used for the three-doses IM PrEP schedule, in comparison with the active-control vaccine Verorab®.
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.
Blood samples for immunogenicity assessment will be collected at Day 0, Day 28, and Day 42. For immunogenicity assessment, the blood sample at Day 28 will be used for the two-doses IM PrEP schedule, and the blood sample at Day 42 will be used for the three-doses IM PrEP schedule, in comparison with the active-control vaccine Verorab®.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: