CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 405 enrolled
Drug / intervention
MF59-eH5N1 +2 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/NCT00481065
NCT00481065Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Controlled, Open Label, Single-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of an H5N1-vaccine and a Seasonal Influenza Vaccine in Adult Subjects

Novartis·interventional·Posted Jun 1, 2007·Updated Feb 3, 2014

In Brief

A Phase 2 clinical trial evaluating MF59-eH5N1, eTIV_a, and 1 other intervention for Pandemic and Avian Influenza. Completed, enrolled 405 participants across 1 site.

Detailed Summary

This study evaluates the immunogenicity, safety and tolerability of an H5N1 vaccine with a seasonal trivalent influenza vaccine, containing the strains recommended by WHO for the 2007 influenza season in the Southern Hemisphere.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPandemic, Avian Influenza
CountriesColombia
CollaboratorsNovartis Vaccines

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 1, 2007
Enrollment StartApr 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.1 years ago

Interventions

MF59-eH5N1biological

eTIV_abiological

MF59-eH5N1 + eTIV_abiological