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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
LAIV
IIV
Sponsored by
Marshfield Clinic Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Immune Response to Influenza Vaccine focused on measuring Immune response to influenza vaccine, PCR confirmed Influenza A virus, PCR confirmed Influenza B virus

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marshfield Clinic - Marshfield Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

LAIV 2014-15

IIV 2014-15

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza

Secondary Outcome Measures

Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)

Full Information

First Posted
September 17, 2014
Last Updated
March 26, 2018
Sponsor
Marshfield Clinic Research Foundation
Collaborators
Centers for Disease Control and Prevention, University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02250274
Brief Title
Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
Official Title
Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshfield Clinic Research Foundation
Collaborators
Centers for Disease Control and Prevention, University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response to Influenza Vaccine, Influenza A Virus Infection, Influenza B Virus Infection
Keywords
Immune response to influenza vaccine, PCR confirmed Influenza A virus, PCR confirmed Influenza B virus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LAIV 2014-15
Arm Type
Other
Arm Description
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.
Arm Title
IIV 2014-15
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
LAIV
Other Intervention Name(s)
FluMist
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
IIV
Other Intervention Name(s)
FluZone
Intervention Description
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.]
Primary Outcome Measure Information:
Title
Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
Time Frame
Change from Baseline to 28 days
Secondary Outcome Measure Information:
Title
Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
Time Frame
Onset >13 days after vaccination and before April 1, 2015
Title
Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
Time Frame
Change from Baseline to 28 days
Title
Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward A Belongia, MD
Organizational Affiliation
Marshfield Clinic Research Foundation - Center for Clinical Epidemiology & Population Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marshfield Clinic - Marshfield Center
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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