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Immunogenicity of H5N1 Vaccine Following H5N2

NCT02153671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-02-18

Study results available
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Summary

This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can induce a long-lasting immune memory by comparing the immunologic response to two doses of the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who did not received LAIV.

Conditions

  • Influenza Vaccine

Interventions

BIOLOGICAL

A(H5N1) inactivated influenza vaccine (IIV)

Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.

BIOLOGICAL

A(H5N2) live attenuated influenza vaccine (LAIV)

Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV

Sponsors & Collaborators

  • Institute of Experimental Medicine, Russia

    collaborator OTHER

  • Research Institute of Influenza, Russia

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Russia

Study Locations

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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 NCT02153671 on ClinicalTrials.gov