Reactogenicity, Safety and Immunogenicity of a LAIV H7N9 Influenza Vaccine

NCT02480101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-06-24

No results posted yet for this study

Summary

This is a single centre phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Anhui/2013/61 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age .

Conditions

Interventions

BIOLOGICAL

H7N9 live influenza vaccine

H7N9 live influenza vaccine

BIOLOGICAL

Placebo

Lyophilized purified allantoic fluid of chicken embryos with stabilizers

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER
  • Institute of Experimental Medicine, Russia

    collaborator OTHER
  • Research Institute of Influenza, Russia

    lead OTHER

Principal Investigators

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

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
2014-10-31
Primary Completion
2014-12-31
Completion
2015-04-30

More Related Trials

Entities

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 NCT02480101 on ClinicalTrials.gov