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

March 26, 2018 updated by: Edward Belongia, Marshfield Clinic Research Foundation

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Practices, children 5-8 years old will preferentially receive live attenuated influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed influenza vaccine will be excluded from the study.

The children will have their blood drawn between 2 and 4 times total over the course of two months in order to test their immune response to the vaccine. Between approximately December and April, study participants will be contacted weekly to monitor for any new respiratory illnesses with cough, and if present, nasal and throat swabs will be collected to test for influenza.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic - Marshfield Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LAIV 2014-15
Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
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.
Other Names:
  • FluMist
Other: IIV 2014-15
Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
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.]

Other Names:
  • FluZone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
Time Frame: Change from Baseline to 28 days
Change from Baseline to 28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
Time Frame: Onset >13 days after vaccination and before April 1, 2015
Onset >13 days after vaccination and before April 1, 2015
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Time Frame: Change from Baseline to 28 days
Change from Baseline to 28 days
Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marshfield Clinic Research Foundation

Collaborators

University of Wisconsin, Madison
Centers for Disease Control and Prevention

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

September 17, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

April 26, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5U01IP000471-04 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is a plan to publish the results of the study in a manuscript but no plans to release individual level data as the results are not clinically actionable.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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