NCT00644059

Study to Evaluate the Efficacy, Safety and Immunogenicity of Influenza Vaccine in Healthy Subjects (Aged 6 to <72 Months) Versus Control Vaccines

A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to <72 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,902 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 6 Months – 71 Months
• Healthy volunteers: Accepted

Summary

This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \<72 months of age.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted trivalent inactivated subunit influenza vaccine	Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
BIOLOGICAL	Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine	For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.
BIOLOGICAL	Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine	1. Meningococcal vaccine: two IM injections 2. Tick-borne encephalitis vaccine: two IM injections

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-04-01
• Completion: 2010-08-01
• First posted: 2008-03-26
• Last updated: 2015-09-18
• Results posted: 2014-10-15

Locations

101 sites across 3 countries: Finland, Germany, Italy