Assess the Safety & Immunogenicity of Stored Inactivated Influenza H5N1 Virus Vaccine Given With & Without Stored MF59 Adjuvant

PHASE2CompletedINTERVENTIONAL
Enrollment

422

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

May 13, 2016

Study Completion Date

March 31, 2017

Conditions
A/Vietnam/H5N1 Influenza Virus
Interventions
BIOLOGICAL

7.5 mcg H5N1 (stored as monobulk)

BIOLOGICAL

15 mcg H5N1 (stored as monobulk)

BIOLOGICAL

90 mcg H5N1 (stored as monobulk)

BIOLOGICAL

90 mcg H5N1 (stored in vials)

OTHER

MF59

OTHER

MF59 (stored as monobulk)

Trial Locations (6)

14609

Rochester Clinical Research, Inc., Rochester

30328

Radiant Research, Inc., Atlanta

40509

Central Kentucky Researcch Associates, Inc., Lexington

51503

Clinical Research Advantage, Inc./Ridge Family Practice, Council Bluffs

55435

Radiant Research, Inc., Edina

66219

Johnson County Clin-Trials, Inc., Lenexa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Biomedical Advanced Research and Development Authority

FED