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Safety Trial of Live Attenuated Influenza (H7N3) Vaccine

NCT01511419 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-22

Study results available
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Summary

The study hypothesis is that two doses of cold-adapted, live monovalent A/17/mallard/Netherlands/00/95 (H7N3) influenza vaccine will be safe and immunogenic in healthy adults.

Conditions

Interventions

BIOLOGICAL

LAIV H7N3

2 doses of vaccine

BIOLOGICAL

placebo

2 doses of placebo

Sponsors & Collaborators

  • Ministry of Health, Russian Federation

    collaborator OTHER_GOV

  • Research Institute of Influenza, Russia

    collaborator OTHER

  • Institute of Experimental Medicine, Russia

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Oleg I Kiselev, MD, PhD, DSc · Research Institute of Influenza

  • Larisa G Rudenko, MD, PhD, DSc · Institute of Experimental Medicine

  • Kathleen M Neuzil, MD, MPH · PATH Vaccine Solutions

  • Igor Victorevich · Microgen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

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 NCT01511419 on ClinicalTrials.gov