NCT01992107

Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to < 18 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,333 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Accepted

Summary

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	QIVc	Novartis Investigational Quadrivalent Vaccine
BIOLOGICAL	TIV1c	Licensed Influenza Vaccine
BIOLOGICAL	TIV2c	Novartis Investigational Vaccine

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-11-25
• Last updated: 2015-12-08
• Results posted: 2015-12-08

Locations

88 sites across 1 country: United States