NCT01346592

Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age

A Phase III, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu Compared to the Non-adjuvanted Trivalent Influenza Vaccine Fluzone in Children 6 to < 72 Months of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6,104 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 72 Months
• Healthy volunteers: Accepted

Summary

This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to \< 72 Months of Age.

Conditions

• Influenza Disease

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent split influenza vaccine (TIV)
BIOLOGICAL	MF59-adjuvanted trivalent influenza vaccine (aTIV)
BIOLOGICAL	Licensed comparator trivalent split influenza vaccine (comparator TIV)

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-05-03
• Last updated: 2015-03-26
• Results posted: 2014-05-06

Locations

34 sites across 5 countries: Argentina, Australia, Chile, Philippines, South Africa