CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 392 enrolled
Drug / intervention
0.5mL Intramuscular Injectionbiological
Likely dose
0.5mL Intramuscular Injectionfrom 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/NCT01147068
NCT01147068Phase 2Completed
CompareCT.gov

A Two-Part Placebo-Controlled Evaluation of the Safety and Immunogenicity of an A/Indonesia/5/05 Recombinant Hemagglutinin Influenza H5N1 Vaccine With and Without Glucopyranosyl Lipid A (GLA-SE) in Healthy Adults 18-49

Protein Sciences Corporation·interventional·Posted Jun 22, 2010·Updated Nov 26, 2012

In Brief

A Phase 2 clinical trial evaluating 0.5mL Intramuscular Injection for Influenza. Completed, enrolled 392 participants across 4 sites.

Detailed Summary

The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2010
Enrollment StartJun 1, 2010
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.0 years ago

Interventions

0.5mL Intramuscular Injectionbiological

0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle