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Reactogenicity, Safety and Immunogenicity of a LAIV А/17/Hong Kong/2017/75108 H7N9 Influenza Vaccine

NCT03739229 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-11-13

No results posted yet for this study

Summary

This is a single center phase I, double-blind placebo-controlled study to assess reactogenicity, safety and immunogenicity of a live monovalent A/17/Hong Kong/2017/75108 (H7N9) influenza vaccine in healthy male and female adults, 18 through 49 years of age.

Conditions

  • Vaccine Adverse Reaction

Interventions

BIOLOGICAL

Placebo

2 intranasal administrations of lyophilized purified allantoic fluid of chicken embryos with stabilizers

BIOLOGICAL

H7N9 LAIV

2 intranasal administrations of H7N9 live influenza vaccine

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Institute of Experimental Medicine, Russia

    collaborator OTHER

  • Joint Stock Company Microgen, Russia

    collaborator UNKNOWN

  • 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
2018-12-03
Primary Completion
2019-06-03
Completion
2019-07-03

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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 NCT03739229 on ClinicalTrials.gov