NCT03614975

Immunologic Response to Influenza Vaccination in Children and Adolescents

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Richard Zimmerman MD · Academic / Other
• Sex: All
• Age: 4 Years – 20 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed 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.

Conditions

• Influenza, Human
• Immune Response

Interventions

Type	Name	Description
BIOLOGICAL	Flucelvax inactivated influenza vaccine	Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
BIOLOGICAL	Fluzone inactivated influenza vaccine	Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)

Timeline

• Start date: 2018-09-13
• Primary completion: 2018-12-13
• Completion: 2018-12-13
• First posted: 2018-08-03
• Last updated: 2020-01-18
• Results posted: 2019-11-12

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study