NCT00192205

Trial to Compare the Safety,Tolerability and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children

A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability and Efficacy of Influenza Virus Vaccine, Trivalent, Type A&B, Live, Cold-Adapted (CAIV-T) With Influenza Virus Vaccine, Trivalent, Inactivated (TIV) in Children With a History of Recurrent Respiratory Tract Infections Aged 6 Months to Less Than 72 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,200 (planned)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Not accepted

Summary

\- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.

Detailed description

* The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age. * The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	CAIV-T or TIV

Timeline

• Start date: 2002-10-01
• Completion: 2003-06-01
• First posted: 2005-09-19
• Last updated: 2006-10-03

Locations

2 sites across 2 countries: Israel, Spain