CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 465 enrolled
Drug / intervention
FluMist live attenuated influenza vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03982069
NCT03982069Phase 4Completed
CompareCT.gov

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

Richard Zimmerman MD·interventional·Posted Jun 11, 2019·Updated Oct 14, 2021

In Brief

A Phase 4 clinical trial evaluating FluMist live attenuated influenza vaccine and Flucelvax inactivated influenza vaccine for Influenza, Human and Immune Response. Completed, enrolled 465 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human, Immune Response
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedJun 11, 2019
Enrollment StartSep 20, 2019
Primary CompletionDec 9, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.1 years ago

Interventions

FluMist live attenuated influenza vaccinebiological

Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.

Flucelvax inactivated influenza vaccinebiological

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.