CompletedInterventionalPhase 2Last updated Mar 28, 2016

Safety and Immunogenicity of Two Doses of a Tetravalent Influenza Vaccine in Adults Aged 18 Years and Above

A Phase II, Randomized, Placebo-controlled, Observer-blind, Multi Center Study on the Safety and Immunogenicity of Novartis Tetravalent Influenza Vaccine (Containing Both Interpandemic Strains and H5N1) in Adults Aged 18 Years and Above

Overview

ClinicalTrials.gov ID: NCT00620815
Lead Sponsor: Novartis VaccinesINDUSTRY
Brief Summary: Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)
Study Type: Interventional

Interventions

Biological: MF59-eTIV-H5N1+ placebo /pandemic influenza vaccineBiological: Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1Biological: Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccineBiological: Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1Biological: Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccineBiological: MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccine

Status

Overall Status: Completed
Start Date: Nov 2007
Primary Completion Date: Jan 2008Actual
Completion Date: Dec 2008Actual

Study Record Dates

First Submitted: Feb 12, 2008
First Submitted that Met QC Criteria: Feb 21, 2008
First Posted: Feb 22, 2008Estimated
Last Update Submitted that Met QC Criteria: Mar 3, 2016
Last Update Posted: Mar 28, 2016Estimated
Last Verified: Mar 2016

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