NCT02250274

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Marshfield Clinic Research Foundation · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

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

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2015-04-01
• First posted: 2014-09-26
• Last updated: 2018-04-26
• Results posted: 2016-02-26

Locations

1 site across 1 country: United States