Immunologic Response to FluMist vs. Flucelvax

Richard Zimmerman MD

Status and phase

Completed

Phase 4

Conditions

Influenza, Human

Immune Response

Treatments

Biological: FluMist live attenuated influenza vaccine

Biological: Flucelvax inactivated influenza vaccine

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT03982069

STUDY19040242

1U01|P001035-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment

465 patients

Sex

All

Ages

4 to 21 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

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