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

NCT02250274 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2018-04-26

Study results available
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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).

Conditions

  • Immune Response to Influenza Vaccine
  • Influenza A Virus Infection
  • Influenza B Virus Infection

Interventions

BIOLOGICAL

LAIV

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.

BIOLOGICAL

IIV

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. \[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.\]

Sponsors & Collaborators

Principal Investigators

  • Edward A Belongia, MD · Marshfield Clinic Research Foundation - Center for Clinical Epidemiology & Population Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250274 on ClinicalTrials.gov