Trials / Completed
CompletedNCT03700242
Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Post-Exposure Prophylaxis Regimen at One Year
Imovax® Rabies and VERORAB® Immunogenicity and Safety After One Week 2-sites Intradermal or 1-site Intramuscular Pre-Exposure Prophylaxis Regimens, Followed by a Simulated Intradermal or Intramuscular Post-Exposure Prophylaxis Regimen at One Year
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 570 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Accepted
Summary
The primary objective of the study is to demonstrate that a short intramuscular (IM) pre-exposure prophylaxis (PrEP) regimen is non-inferior to the reference IM PrEP regimen in terms of seroconversion rate. The secondary objectives of the study are: * To describe the immunogenicity of the PrEP regimen in each group * To describe the antibody persistence in each group 6 months and 1 year after the last PrEP vaccination * To describe the immunogenicity of the simulated post-exposure prophylaxis (PEP) regimen in each group * To describe the safety profile of study vaccines administered as PrEP regimen and as a simulated PEP regimen in each group
Detailed description
Study duration per participant is approximately 403 to 436 days
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HDCV | Pharmaceutical form:Solution for injection Route of administration: Intramuscular |
| BIOLOGICAL | HDCV | Pharmaceutical form:Solution for injection Route of administration: Intradermal |
| BIOLOGICAL | PVRV | Pharmaceutical form:Solution for injection Route of administration: Intramuscular |
| BIOLOGICAL | PVRV | Pharmaceutical form:Solution for injection Route of administration: Intradermal |
Timeline
- Start date
- 2018-09-26
- Primary completion
- 2019-01-19
- Completion
- 2020-04-08
- First posted
- 2018-10-09
- Last updated
- 2022-04-25
Locations
2 sites across 1 country: Philippines
Source: ClinicalTrials.gov record NCT03700242. Inclusion in this directory is not an endorsement.