A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist

PHASE1CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

March 31, 2007

Study Completion Date

March 31, 2007

Conditions
Influenza
Interventions
BIOLOGICAL

FluMist

Live attenuated influenza vaccine (LAIV) containing approximately 10\^7 TCID50 of each of the 3 influenza strains. 0.5 mL total dose volume administered intranasally via spray applicator (approximately 0.25 mL into each nostril). Administration of Flumist in children under 5 years of age is investigational.

BIOLOGICAL

Fluzone

Trivalent inactivated vaccine (TIV), licensed Fluzone preservative free pediatric dose, 0.25 mL administered intramuscularly to the anterolateral thigh muscle or deltoid muscle.

Trial Locations (3)

37232

Vanderbilt University, Nashville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

63104

Saint Louis University, St Louis

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00231907 - A Phase I Safety and Immunogenicity Study of Mix and Match of Licensed Flu Vaccine and Flumist | Biotech Hunter | Biotech Hunter