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

Completed · Phase 4

Conditions studied: Immune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection

In brief

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 years old. The effects of prior infection and or prior season vaccination will be examined. Children will be followed during the influenza season to identify laboratory-confirmed influenza (i.e. vaccine failure).

Key facts

Study ID

NCT02250274

Run by

Marshfield Clinic Research Foundation

People needed

131

Starts

2014-09-01

Expected to finish

2015-04-01

Last updated by the study team

2018-04-26

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Marshfield Clinic - Marshfield Center — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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