H7N9 Mix and Match With MF59 in Healthy Adults

PHASE2CompletedINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
Influenza
Interventions
BIOLOGICAL

Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013

Monovalent influenza A/H7N9 virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension. sanofi A/H7N9 antigen. Group 1 receives 3.75mcg A/H7N9 IM on days 1 and 21, Group 2 receives 7.5 mcg IM on days 1 and 21, Group 3, 4, 5, \& 6 receives 15 mcg IM on days 1 and 21, and Group 7 receives 45 mcg IM on days 1 and 21.

DRUG

MF59

MF59 adjuvant is an oil-in-water emulsion composed of a small amount of squalene administered with different dosages. Group 1, 2 \& 3 receives 0.7 ml of MF59 Intramuscularly (IM) on days 0 and 21. Group 4 receives MF59 on day 0, Group 5 receives MF59 on Day 21.

Trial Locations (4)

30030-1705

Emory Vaccine Center - The Hope Clinic, Decatur

52242-1009

University of Iowa - Infectious Disease Clinic, Iowa City

45229-3026

Cincinnati Children's Hospital Medical Center - Infectious Diseases, Cincinnati

77555-5302

University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston, Galveston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT01938742 - H7N9 Mix and Match With MF59 in Healthy Adults | Biotech Hunter | Biotech Hunter