NCT00344305

A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children

A Phase 2, Open-Label, Single Arm Trial to Evaluate the Shedding and Safety of CAIV-T Administered to Children 6 to Less Than 60 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Accepted

Summary

Open label, single arm, multicenter study of the shedding and safety of a single dose of trivalent, influenza virus vaccine live, intranasal in children 6 to \< 60 months of age, with 28-day shedding follow-up and 180-day safety follow-up.

Detailed description

This was a Phase 2, open-label, single-arm, multicenter study designed to evaluate vaccine virus shedding and safety of trivalent influenza virus vaccine live, intranasal in children 6 to \< 60 months of age. Enrollment of approximately 200 participants was stratified by age, with 100 participants 6 to \< 24 months of age (who reached their sixth month but not their second year birthday) and 100 participants 24 to \< 60 months of age (who reached their second year but not their fifth year birthday). Baseline medical history data collection included the participants prior receipt of influenza vaccine or history of laboratory-confirmed influenza illness in the previous influenza season.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent influenza virus vaccine live, intranasal	A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10\^7 FFU of three influenza virus strains.

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-07-01
• Completion: 2006-12-01
• First posted: 2006-06-26
• Last updated: 2017-07-24
• Results posted: 2010-11-01

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study