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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

NCT03700242 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570

Last updated 2022-04-25

No results posted yet for this study

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

Conditions

  • Healthy Volunteers (Rabies Immunization)

Interventions

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

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2019-01-19
Completion
2020-04-08

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03700242 on ClinicalTrials.gov