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Study of Purified Vero Rabies Vaccine Compared With Two Reference Rabies Vaccines, Given in a Pre-exposure Regimen to Children and Adults and as Single Booster Dose to a Subset of Adults

NCT04127786 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1708

Last updated 2026-02-10

Study results available
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Summary

The primary objective of this study is:

To demonstrate the VRVg-2 is non-inferior to Verorab and Imovax Rabies vaccines in each age group (pediatric and adult populations) when administered as a 3-dose PrEP regimen, in terms of proportion of participants achieving a rabies virus neutralizing antibody (RVNA) titer ≥ 0.5 IU/mL at Day 42, ie. 14 days after the 3rd injection (for Primary Series Cohort 1).

The secondary objectives of this study are: First 1-5 with hypotheses testing will be evaluated sequentially - only if the previous objective is achieved, will the next objective be tested

To demonstrate that:

* the observed proportion of participants in the VRVg2(VRVg) group at D42 is at least 99% with a lower limit of the 95% confidence interval (CI) of at least 97%
* VRVg is non inferior (NI) to Verorab and Imovax Rabies vaccines (Imovax) in each age group at D28
* 2-dose VRVg at D28 is NI to 3-dose Imovax at D42 in each age group
* the observed proportion of participants in the VRVg group at D28 is at least 99% with a lower limit of the 95% CI of at least 97%
* 2-dose Imovax at D28 is NI to 3-dose Imovax at D42 in overall participants (Cohort1)

To describe:

* the immune response induced by VRVg versus Verorab and Imovax at D28 and at D42 in all age groups
* the immune response induced by VRVg at D14 after a booster dose of VRVg administered at M12 (Cohort1) and between M24 up to M36 (Cohort2)
* the persistence of immune response at M6,12,18, and pre-booster between M24 up to M36 post-primary series vaccination (Cohort2)
* safety profile of VRVg versus Verorab and Imovax in primary series and after a booster dose of VRVg

Conditions

  • Rabies
  • Healthy Volunteers

Interventions

BIOLOGICAL

Purified vero rabies vaccine - serum free - VRVg-2

Pharmaceutical form: Freeze-dried Route of administration: Intramuscular

BIOLOGICAL

Purified inactivated rabies vaccine - Verorab®

Pharmaceutical form:Freeze-dried Route of administration: Intramuscular

BIOLOGICAL

Purified inactivated rabies vaccine - Imovax® Rabies

Pharmaceutical form: Freeze-dried Route of administration: Intramuscular

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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2020-03-25
Completion
2025-04-24
FDA Drug
Yes

Countries

  • Thailand

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 NCT04127786 on ClinicalTrials.gov