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Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine

NCT01982331 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2019-02-26

Study results available
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Summary

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

Conditions

Interventions

BIOLOGICAL

LAIV H2N2

vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28

OTHER

Placebo

placebo delivered intranasally. .25cc to each nostril at day 0 and day 28

Sponsors & Collaborators

  • Ministry of Health, Russian Federation

    collaborator OTHER_GOV

  • Institute of Experimental Medicine, Russia

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • Oleg I Kiselev, Ph.D. · Research Institute of Influenza

  • Jorge E Flores, MD, Ph.D. · PATH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-03-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

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 NCT01982331 on ClinicalTrials.gov