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

Marshfield Clinic Research Foundation

Status and phase: Completed; Phase 4

Conditions: Influenza B Virus Infection; Influenza A Virus Infection; Immune Response to Influenza Vaccine

Treatments: Biological: IIV; Biological: LAIV

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02250274

5U01IP000471-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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131 participants in 2 patient groups

LAIV 2014-15

Other group

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.

Treatment:

Biological: LAIV

IIV 2014-15

Other group

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.

Treatment:

Biological: IIV