Clinical Trials Directory

Trials / Completed

CompletedNCT01857206

Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
2,055 (actual)
Sponsor
Novartis Vaccines · Industry
Sex
All
Age
4 Years – 17 Years
Healthy volunteers
Accepted

Summary

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Conditions

Interventions

TypeNameDescription
BIOLOGICALMammalian cell based flu vaccine
BIOLOGICALEgg based flu vaccine

Timeline

Start date
2013-05-01
Primary completion
2014-06-01
Completion
2014-06-01
First posted
2013-05-20
Last updated
2014-12-05
Results posted
2014-11-03

Locations

34 sites across 5 countries: United States, Australia, New Zealand, Philippines, Thailand

Source: ClinicalTrials.gov record NCT01857206. Inclusion in this directory is not an endorsement.