A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 18, 2015

Primary Completion Date

August 17, 2018

Study Completion Date

August 17, 2018

Conditions
Avian InfluenzaImmunisation
Interventions
BIOLOGICAL

Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca

MedImmune supplies pLAIV vaccines as a colorless to pale yellow and clear to slightly cloudy suspension in single, unit-dose, Becton-Dickinson Accuspray™ Nasal Spray Systems sprayer devices. Each filled sprayer device contains a 0.5 mL dose of 10\^7FFU of H7N9 Anhui 2013/AA ca vaccine. Group I receives the IN dose on Day 29, Group 2 on Day 85, and Group 3 on Day 169.

BIOLOGICAL

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

Sanofi supplies the monovalent influenza A/H7N9 virus vaccine as a sterile, clear, and slightly opalescent suspension in single-dose vials containing 15 mcg HA per 0.5 mL. Group 1 through Group5 will receive the IM vaccine on Day 1

DRUG

MF59 adjuvant

Novartis supplies the MF59 adjuvant as an oil-in-water milky emulsion in single-use vials containing a fill volume of 0.7 mL. Group 1 through Group 5 will receive MF59 IM on Day 1.

Trial Locations (1)

14642-0001

University of Rochester Medical Center - Vaccine Research Unit, Rochester

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT02251288 - A Phase I Study Priming With an Inactivated A/H7N9 Influenza Virus Vaccine With or Without MF59 Adjuvant Followed by Live Attenuated A/H7N9 Influenza Virus Vaccine | Biotech Hunter | Biotech Hunter