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Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)

NCT01910519 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-12

Study results available
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Summary

This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.

Conditions

  • Influenza A Virus, H5N1 Subtype

Interventions

BIOLOGICAL

H5N1 vaccine plus AS03 adjuvant

Administered vaccine: \[GlaxoSmithKline\] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted. Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart.

BIOLOGICAL

H5N1 vaccine without adjuvant

Administered vaccine: \[GlaxoSmithKline\] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant. Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Nadine Rouphael, MD · Hope Clinic, Emory University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2015-02-28
Completion
2015-11-30

Countries

  • United States

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 NCT01910519 on ClinicalTrials.gov