NCT00464672

Safety, and Immunogenicity of Two Influenza Vaccines in Healthy Subjects 3 to 64 Years Old

A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Immunogenicity of Two Trivalent Subunit Inactivated Influenza Vaccines in Healthy Children Aged 3 to 8 Years, in Healthy Children/Adolescents Aged 9 to 17 Years,and in Healthy Adults Aged 18 to 64 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,893 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 3 Years – 64 Years
• Healthy volunteers: Accepted

Summary

This protocol is designed to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine licensed in the EU and many other worldwide countries, according to the US FDA Draft Guidance for Industry "Clinical data needed to support the licensure of trivalent inactivated influenza vaccine", issued in March 2006, and to evaluate safety, clinical tolerability and immunogenicity of the 2007 southern hemisphere formulation of a Novartis conventional influenza vaccine already licensed in US. The purpose of the control arm is primarily to provide a comparative assessment for safety, not immunogenicity or effectiveness.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza virus vaccine	Two intramuscular injections of the investigational influenza virus vaccine administered 4 weeks part to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.
BIOLOGICAL	Comparator influenza vaccine	Two intramuscular injections were administered 4 weeks apart to group 3 to 8 years of age while one injection was administered to groups 9 to 17 years of age and 18 to 64 years of age.

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-07-01
• Completion: 2007-12-01
• First posted: 2007-04-24
• Last updated: 2015-10-01
• Results posted: 2010-05-05

Locations

2 sites across 1 country: Argentina