NCT01209780

Safety and Immunogenicity of Trivalent Subunit Inactivated Flu Vaccine Administered to Healthy Children and Adolescents 3 to 17 Years of Age

A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,116 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	TIV	Investigational egg-derived trivalent subunit influenza vaccine.
BIOLOGICAL	TIVf	US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.
BIOLOGICAL	Comparator TIV	US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children \<4 years.

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-03-01
• Completion: 2011-09-01
• First posted: 2010-09-27
• Last updated: 2014-03-11
• Results posted: 2014-03-11

Locations

13 sites across 4 countries: Colombia, Mexico, Panama, Philippines