Immunologic Response to Influenza Vaccination in Children and Adolescents
Immunologic Response to Influenza Vaccination in Children and Adolescents
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).
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.
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