Immunologic Response to Influenza Vaccination in Children and Adolescents

Richard Zimmerman MD

Status and phase

Completed

Phase 4

Conditions

Influenza, Human

Immune Response

Treatments

Biological: Flucelvax inactivated influenza vaccine

Biological: Fluzone inactivated influenza vaccine

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT03614975

CDCU01IP001035 (Other Grant/Funding Number)

PRO18050091

Details and patient eligibility

About

The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).

Full description

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-20 years given one of two FDA approved and licensed influenza vaccines: Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot). This study will enroll 120 healthy participants, 60 per vaccine arm. Participants will be randomized using a 1:1 allocation to receive either Flucelvax or Fluzone. Blood work will be conducted on all participants at baseline prior to vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 21 (range 21-35 days). The primary objective of the study is to determine pre and post serologic,responses to each vaccine type.

Enrollment

166 patients

Sex

All

Ages

4 to 20 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

aged 4-20 years;
has prior vaccination history available (which can be determined based either on medical record review or through state registry review;
plans to receive the current seasonal influenza vaccination at one of the recruiting sites

Exclusion criteria

unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork;
has already received influenza vaccine for the current season;
has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days);
is known to be pregnant;
has a history of severe allergy to eggs or to influenza vaccine or any of its components