Immunologic Response to FluMist vs. Flucelvax

Completed · Phase 4

Conditions studied: Influenza, Human, Immune Response

In brief

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).

Key facts

Study ID

NCT03982069

Run by

Richard Zimmerman MD

People needed

465

Starts

2019-09-20

Expected to finish

2020-12-09

Last updated by the study team

2021-10-14

Who can join

Age: 4 and older, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• aged 4-21 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

You may not qualify if…

• 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

Where it is running

• General Academic Pediatrics — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Department of Family Medicine — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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