Immunologic Response to Influenza Vaccination in Children and Adolescents

Immunologic Response to Influenza Vaccination in Children and Adolescents: A RCT Trial of Influenza Vaccines

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