CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
ccIIV4 +1 moredrug
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/NCT02967393
NCT02967393Phase 4Completed
CompareCT.gov

Feasibility Study to Assess the Safety of Quadrivalent, Live Attenuated Influenza Vaccine (LAIV4) Versus Quadrivalent Inactivated Influenza Vaccine (IIV4) in Children Aged 5-11 Years With Persistent Asthma of Varied Severity (Cell Culture Quadrivalent IIV Used as Surrogate for LAIV4)

Vanderbilt University Medical Center·interventional·Posted Nov 18, 2016·Updated Apr 23, 2018

In Brief

A Phase 4 clinical trial evaluating ccIIV4 and IIV4 for Asthmatic. Completed, enrolled 40 participants across 4 sites.

Detailed Summary

This study is designed to note whether a larger safety study using quadrivalent live attenuated influenza vaccine (LAIV4) versus quadrivalent inactivated influenza vaccine (IIV4)(FLUARIX®), would be feasible in children with persistent asthma. Half of the patients in this study will receive the FLUARIX® influenza vaccine, while the other half will receive a cell cultured quadrivalent inactivated influenza vaccine (ccIIV4)(Flucelvax®) being used as a surrogate for LAIV4.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthmatic
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention, Duke University, Children's Hospital Medical Center, Cincinnati

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 18, 2016
Enrollment StartOct 10, 2016
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.6 years ago

Interventions

ccIIV4drug

IIV4drug