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

• ClinicalTrials.gov Identifier: NCT02250274
• Recruitment Status: Completed
• First Posted: September 26, 2014
• Results First Posted: February 26, 2016
• Last Update Posted: April 26, 2018
• Sponsor: Marshfield Clinic Research Foundation
• Collaborators: Centers for Disease Control and Prevention; University of Wisconsin, Madison
• Information provided by (Responsible Party): Edward Belongia, Marshfield Clinic Research Foundation

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).

Condition or disease	Intervention/treatment	Phase
Immune Response to Influenza Vaccine; Influenza A Virus Infection; Influenza B Virus Infection	Biological: LAIV; Biological: IIV	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents
• Study Start Date: September 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: April 2015

Arms and Interventions

Arm	Intervention/treatment
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 Name: FluMist
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 Name: FluZone

Outcome Measures

Primary Outcome Measures :

1. Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza [ Time Frame: Change from Baseline to 28 days ]

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Wisconsin

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, United States, 54449

Sponsors and Collaborators

Marshfield Clinic Research Foundation

Centers for Disease Control and Prevention

University of Wisconsin, Madison

Investigators

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

More Information

• Responsible Party: Edward Belongia, Director of Center for Clinical Epidemiology and Population Health, Marshfield Clinic Research Foundation
• ClinicalTrials.gov Identifier: NCT02250274
• Other Study ID Numbers: 5U01IP000471-04 ( U.S. NIH Grant/Contract )
• First Posted: September 26, 2014
• Results First Posted: February 26, 2016
• Last Update Posted: April 26, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

Keywords provided by Edward Belongia, Marshfield Clinic Research Foundation:

Immune response to influenza vaccine; PCR confirmed Influenza A virus; PCR confirmed Influenza B virus

Additional relevant MeSH terms:

Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Herpesviridae Infections; Disease Attributes; Pathologic Processes; Respiratory Tract Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases; DNA Virus Infections