Skip to main content
OpenTrials
Completed

NCT Number: NCT02250274

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Marshfield Clinic - Marshfield Center

Marshfield, Wisconsin, 54449, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: FluMist

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.]

Other names: FluZone

Primary outcomes

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

    Time frame: Change from Baseline to 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Marshfield Clinic Research Foundation

Other

Collaborators

  • Centers for Disease Control and Prevention
  • University of Wisconsin, Madison

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 26, 2014
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.