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

NCT02250274 | Completed Phase 4 Results

• 1 other identifier: 5U01IP000471-04
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

  Change from Baseline to 28 days

Secondary Outcomes (3)

• Polymerase Chain Reaction (PCR) Confirmed Influenza Illness

  Onset >13 days after vaccination and before April 1, 2015

• Antibody Dependent Cellular Cytotoxicity (ADCC) Titers

  Change from Baseline to 28 days

• Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)

  Day 7

Study Arms (2)

LAIV 2014-15

OTHER

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

IIV 2014-15

OTHER

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

Interventions

LAIV BIOLOGICAL

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.

Also known as: FluMist

LAIV 2014-15

IIV BIOLOGICAL

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

Also known as: FluZone

IIV 2014-15

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marshfield Clinic Research Foundation: lead
• Centers for Disease Control and Prevention: collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Interventions

FluMist; Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Director of the Center for Clinical Epidemiology & Population Health
• Organization: Marshfield Clinic Research Foundation

belongia.edward@mcrf.mfldclin.edu

715-389-3444

Study Officials

• Edward A Belongia, MD

  Marshfield Clinic Research Foundation - Center for Clinical Epidemiology & Population Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Center for Clinical Epidemiology and Population Health

Study Record Dates

• First Submitted: September 17, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 26, 2018
• Results First Posted: February 26, 2016

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)