H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology

PHASE1CompletedINTERVENTIONAL
Enrollment

388

Participants

Timeline

Start Date

January 9, 2017

Primary Completion Date

December 19, 2018

Study Completion Date

December 19, 2018

Conditions
Avian Influenza
Interventions
DRUG

AS03

AS03 oil-in-water emulsion adjuvant.

DRUG

MF59

Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.

BIOLOGICAL

Monovalent Influenza A/H5N8 vaccine

Monovalent inactivated influenza A/H5N8 virus vaccine for IM injection. prepared from influenza virus propagated in chicken egg fluid using seed virus prepared from the candidate vaccine virus (CVV), influenza virus A/gyrfalcon/Washington/41088-6/2014(H5N8)-PR8-IDCDC-RG43A (abbreviated as IDCDC-RG43A).

Trial Locations (7)

27704

Duke Vaccine and Trials Unit, Durham

30322-1014

Emory University School of Medicine, Atlanta

21201-1509

University of Maryland Baltimore - School of Medicine - Medicine, Baltimore

63104-1015

Saint Louis University Center for Vaccine Development, St Louis

45229-3039

Cincinnati Children's Hospital Medical Center Vaccine Research Center, Cincinnati

37232-2573

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center, Nashville

77555-1121

The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD), Galveston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03014310 - H5N8 Mix and Match With or Without AS03 or MF59 in Healthy Adults: Immunology | Biotech Hunter | Biotech Hunter