CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
H5N1 vaccine plus AS03 adjuvant +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/NCT01910519
NCT01910519Phase 2Completed
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Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without AS03 Adjuvant (HIPC: VAX-010)

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jul 29, 2013·Updated Feb 12, 2019

In Brief

A Phase 2 clinical trial evaluating H5N1 vaccine plus AS03 adjuvant and H5N1 vaccine without adjuvant for Influenza A Virus, H5N1 Subtype. Completed, enrolled 50 participants across 1 site.

Detailed Summary

This study will compare the different immune responses to Influenza A (H5N1) Virus Monovalent Vaccine with and without the AS03 adjuvant. The Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant vaccine is approved for use for adults to protect against flu caused by the A/H5N1 "bird flu" virus in Europe but none of the vaccines to be used in the study are approved for use in the United States. The results of this study will help researchers learn about better ways to vaccinate people against the H5N1 flu.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza A Virus, H5N1 Subtype
CountriesUnited States
CollaboratorsEmory University

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 29, 2013
Enrollment StartJul 1, 2013
Primary CompletionFeb 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.9 years ago

Interventions

H5N1 vaccine plus AS03 adjuvantbiological

Administered vaccine: \[GlaxoSmithKline\] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted. Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart.

H5N1 vaccine without adjuvantbiological

Administered vaccine: \[GlaxoSmithKline\] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant. Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart.