CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 166 enrolled
Drug / intervention
Flucelvax inactivated 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/NCT03614975
NCT03614975Phase 4Completed
CompareCT.gov

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

Richard Zimmerman MD·interventional·Posted Aug 3, 2018·Updated Jan 18, 2020

In Brief

A Phase 4 clinical trial evaluating Flucelvax inactivated influenza vaccine and Fluzone inactivated influenza vaccine for Influenza, Human and Immune Response. Completed, enrolled 166 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 4-20 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).

Study Details

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

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 3, 2018
Enrollment StartSep 13, 2018
Primary CompletionDec 13, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.9 years ago

Interventions

Flucelvax inactivated influenza vaccinebiological

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.)

Fluzone inactivated influenza vaccinebiological

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.)