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Immunogenicity and Safety of a Purified Vero Rabies Vaccine

NCT03145766 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2022-04-19

Study results available
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Summary

This multicenter, observer-blind, controlled, randomized, Phase II study was designed to evaluate different formulations of the Purified Vero Rabies Cell vaccine VRVg.

Conditions

  • Rabies Virus

Interventions

BIOLOGICAL

VRVg 2

Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free

BIOLOGICAL

VRVg 1

Initial formulation of Purified Vero Rabies Vaccine Serum Free

BIOLOGICAL

Imovax Rabies

Purified inactivated rabies vaccine prepared on human diploid cell cultures

BIOLOGICAL

VRVg 2

Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free

BIOLOGICAL

VRVg 2

Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free

BIOLOGICAL

Human Rabies Immunoglobulins (HRIG)

Commercialized formulation of HRIG

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2018-01-08
Completion
2018-01-08
FDA Drug
Yes

Countries

  • United States

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 NCT03145766 on ClinicalTrials.gov