MedTrace Logo

Intradermal Rabies Immunization Using NanoJect: A Comparative Study

NCT02538185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-03-26

No results posted yet for this study

Summary

The study is planned as a single-center, randomized, double-blind placebo-controlled, comparative Phase I, first-in-man study to assess the safety and tolerability of the NanoJect™ device, and the immunogenicity of the rabies vaccine "Vaccin rabique Pasteur®" delivered with the NanoJect™ device by ID route.

Conditions

  • Intradermal (ID) Vaccination Device

Interventions

DEVICE

NanoJect device (DebioJect™)

The investigational device used in this study is the NanoJect™ device developed by Debiotech company.

DEVICE

Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus)

The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus)

DEVICE

Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)

The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)

DRUG

Vaccin rabique Pasteur®

DRUG

Placebo

Sodium Chloride (NaCl) 0,9%; B. Braun

Sponsors & Collaborators

  • University of Lausanne Hospitals

    lead OTHER

Principal Investigators

  • Giuseppe Pantaleo · CHUV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

More Related Trials

Entities

Drugs

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 NCT02538185 on ClinicalTrials.gov