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

Influenza A Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250274
• Other study ID #: 5U01IP000471-04
• Status: Completed
• Phase: Phase 4
• First received: September 17, 2014
• Last updated: March 26, 2018
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: March 2018
• Source: Marshfield Clinic Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Immune Response to Influenza Vaccine
• Infection
• Influenza A Virus Infection
• Influenza B Virus Infection
• Influenza, Human
• Virus Diseases

Intervention

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.
• 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.]

Locations

Country	Name	City	State
United States	Marshfield Clinic - Marshfield Center	Marshfield	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Marshfield Clinic Research Foundation	Centers for Disease Control and Prevention, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza		Change from Baseline to 28 days
Secondary	Polymerase Chain Reaction (PCR) Confirmed Influenza Illness		Onset >13 days after vaccination and before April 1, 2015
Secondary	Antibody Dependent Cellular Cytotoxicity (ADCC) Titers		Change from Baseline to 28 days
Secondary	Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)		Day 7