NCT00461981

A Phase 2 Study to Evaluate Immune Responses of FluMist®

A Phase 2, Prospective, Randomized, Open-Label Study to Evaluate the Immune Responses of FluMist® Compared With Trivalent Inactivated Vaccine (TIV) in Children 12 to <36 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 12 Months – 35 Months
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against influenza virus strains.

Detailed description

The primary objective of this study is to describe the level of serum antibody and cellular immune responses conferred by FluMist and TIV against antigenically matched and antigenically mismatched influenza virus strains. The secondary objective of this study is to describe the safety of FluMist and TIV in subjects 12 to \<36 months of age.

Conditions

• Influenza Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	TIV, Trivalent Inactivated Influenza Virus Vaccine	0.25 mL will be administered intramuscularly for each of two doses
BIOLOGICAL	FluMist, Influenza Virus Vaccine Live	0.5 mL will be administered intranasally (approximately 0.25 mL into each nostril) for each of two doses

Timeline

• Start date: 2007-05-01
• Primary completion: 2007-12-01
• Completion: 2008-02-01
• First posted: 2007-04-18
• Last updated: 2021-10-06
• Results posted: 2010-02-02

Locations

19 sites across 1 country: United States