Status:

COMPLETED

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

Lead Sponsor:

Novartis Vaccines

Conditions:

Influenza

Fever

Eligibility:

All Genders

4-17 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • \- Healthy subjects 4-17 years of age

Exclusion

  • Subjects who are not healthy,
  • Subjects who are pregnant or breast feeding,
  • Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

Key Trial Info

Start Date :

May 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2014

Estimated Enrollment :

2055 Patients enrolled

Trial Details

Trial ID

NCT01857206

Start Date

May 1 2013

End Date

June 1 2014

Last Update

December 5 2014

Active Locations (34)

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Page 1 of 9 (34 locations)

1

320, Novartis Investigational Site

Mobile, Alabama, United States, 36608

2

312, Novartis Investigational Site

Ponte Vedra, Florida, United States, 32081

3

313, Novartis Investigational Site

Augusta, Kansas, United States, 67010

4

305, Novartis Investigational Site

Newton, Kansas, United States, 67114