CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 12 enrolled
Drug / intervention
Seasonal 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/NCT03701061
NCT03701061Phase 4Completed
CompareCT.gov

Human Immune Responses to an Adjuvanted H5 Vaccine: Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response

Emory University·interventional·Posted Oct 9, 2018·Updated Mar 11, 2020

In Brief

A Phase 4 clinical trial evaluating Seasonal Influenza Vaccine for Influenza A Subtype H5N1 Infection. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The study is a prospective single site exploratory study to examine the impact of Food and Drug Administration (FDA) approved seasonal flu vaccine on the immune responses of H5N1 vaccine previously received with or without the AS03 adjuvant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza A Subtype H5N1 Infection
CountriesUnited States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedOct 9, 2018
Enrollment StartOct 11, 2018
Primary CompletionFeb 28, 2019
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.7 years ago

Interventions

Seasonal Influenza Vaccinebiological

A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study

Seasonal Influenza Vaccinebiological

A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study