Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-18 @ 11:03 PM
Study NCT ID:
NCT01930357
Status:
COMPLETED
Last Update Posted:
2017-04-25
First Post:
2013-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Purified Vero Rabies Vaccine-Serum Free Compared to Human Diploid Cell Vaccine in a Pre-exposure Prophylaxis Regimen
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Safety of the Purified Vero Rabies Vaccine - Serum Free (VRVg) in Comparison With the Human Diploid Cell Vaccine, Imovax® Rabies in a Pre-exposure Prophylaxis Regimen in Healthy Children and Adolescents Aged 2 to 17 Years
Status:
COMPLETED
Status Verified Date:
2017-04
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:
The aim of the study is to document immunogenicity and safety of VRVg in a pre-exposure regimen in healthy children and adolescents aged 2 to 17 years.
Primary Objectives:
* To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.
* To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.
Secondary Objectives:
* To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.
* To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination
* To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.
Primary Objectives:
* To demonstrate that VRVg is non-inferior to Imovax® Rabies in terms of proportion of subjects achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 international units (IU)/mL at D42, i.e. 14 days after the last vaccination.
* To describe if at least 99% of subjects achieve an RVNA titer ≥ 0.5 IU/mL at D42 with a lower bound of the 95% confidence interval (CI) of at least 97%, in the VRVg group.
Secondary Objectives:
* To assess the clinical safety of each vaccine after each vaccine injection when administered in a pre-exposure schedule.
* To describe the immune response induced by each vaccine 14 days after the last vaccination, i.e. at D42, and 6 months after the first vaccination
* To describe the geometric mean titer ratio between the two vaccine groups at D42, i.e. 14 days after the last vaccination.
Detailed Description:
Participants will receive a total of three vaccinations, one each at Day 0, Day 7, and Day 28, respectively, and will be assessment for immune response to rabies vaccine before the first injection (baseline titer), at Day 42, and at Month 6.
Safety will be assessed in all participants up to 28 days after each injection. Serious adverse events and adverse events of special interest (AESIs) will be collected up to 6 months after the last injection.
Safety will be assessed in all participants up to 28 days after each injection. Serious adverse events and adverse events of special interest (AESIs) will be collected up to 6 months after the last injection.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: