Status:

COMPLETED

Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

Lead Sponsor:

Marshfield Clinic Research Foundation

Collaborating Sponsors:

Centers for Disease Control and Prevention

University of Wisconsin, Madison

Conditions:

Immune Response to Influenza Vaccine

Influenza A Virus Infection

Eligibility:

All Genders

5-17 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to assess the serologic and cell-mediated immune response to licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in children 5-17 yea...

Detailed Description

All children will have baseline blood samples drawn and will then be vaccinated with licensed and approved influenza vaccines. Following the recommendation from the Advisory Committee on Immunization ...

Eligibility Criteria

Inclusion

  • Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)
  • Enrolled in either the immune response study or the vaccine effectiveness study conducted at the site in the 2013-14 influenza season
  • If enrolled in the vaccine effectiveness study the previous season must have either been vaccinated and infected with influenza or unvaccinated and uninfected with influenza

Exclusion

  • Children with contraindications to either the quadrivalent live attenuated influenza vaccine or to the trivalent inactivated influenza vaccine will be excluded.
  • Anyone unwilling or unable to complete all required study activities including informed consent
  • Subjects who already received the influenza vaccine for the 2014-15 season

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2015

Estimated Enrollment :

131 Patients enrolled

Trial Details

Trial ID

NCT02250274

Start Date

September 1 2014

End Date

April 1 2015

Last Update

April 26 2018

Active Locations (1)

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Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States, 54449

Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents | DecenTrialz