CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 131 enrolled
Drug / intervention
LAIV +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02250274
NCT02250274Phase 4Completed
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Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents

Marshfield Clinic Research Foundation·interventional·Posted Sep 26, 2014·Updated Apr 26, 2018

In Brief

A Phase 4 clinical trial evaluating LAIV and IIV for Immune Response to Influenza Vaccine and 2 related conditions. Completed, enrolled 131 participants across 1 site.

Detailed 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 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention, University of Wisconsin, Madison

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 26, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.8 years ago

Interventions

LAIVbiological

Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.

IIVbiological

A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV. \[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]