NCT00645411

Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,604 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Cell culture-derived influenza subunit vaccine (cTIV)	One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
BIOLOGICAL	Egg derived influenza subunit vaccine (eTIV)	One 0.5 ml injection of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
BIOLOGICAL	Cell culture-derived influenza subunit vaccine (cTIV)	Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
BIOLOGICAL	Egg derived influenza subunit vaccine (eTIV)	Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-02-01
• Completion: 2008-07-01
• First posted: 2008-03-27
• Last updated: 2015-11-23
• Results posted: 2013-01-16

Locations

60 sites across 7 countries: United States, Croatia, Finland, Hungary, Italy, Lithuania, Romania