NCT00192283

Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers

A Prospective, Randomized, Double-Blind, Placebo-Controlled, Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children Attending Day Care Centers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,903 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	CAIV-T	The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).
OTHER	Placebo	A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).

Timeline

• Start date: 2000-09-01
• Primary completion: 2002-04-01
• Completion: 2002-05-01
• First posted: 2005-09-19
• Last updated: 2009-04-10

Locations

1 site across 1 country: Finland