NCT03982069

Immunologic Response to FluMist vs. Flucelvax

Immunological Response to Influenza Vaccination in Children, Adolescents, and Young Adults: A RCT of FluMist vs. Flucelvax

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Richard Zimmerman MD · Academic / Other
• Sex: All
• Age: 4 Years – 21 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 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).

Detailed description

This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity response in children/adolescents/young adults aged 4-21 years given one of two FDA approved and licensed influenza vaccines: FluMist (live attenuated influenza vaccine by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine). This study will enroll about 440 healthy participants, about 220 per vaccine arm. Participants will be randomized in blocks of 4 using a 1:1 allocation to receive either FluMist or Flucelvax. 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 28 (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	FluMist live attenuated influenza vaccine	Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
BIOLOGICAL	Flucelvax inactivated influenza vaccine	Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.

Timeline

• Start date: 2019-09-20
• Primary completion: 2020-12-09
• Completion: 2020-12-09
• First posted: 2019-06-11
• Last updated: 2021-10-14
• Results posted: 2021-10-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study