CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 601 enrolled
Drug / intervention
MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine +5 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/NCT00620815
NCT00620815Phase 2Completed
CompareCT.gov

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

Novartis Vaccines·interventional·Posted Feb 22, 2008·Updated Mar 28, 2016

In Brief

A Phase 2 clinical trial evaluating MF59-eTIV-H5N1+ placebo /pandemic influenza vaccine, Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1, and 4 other interventions for Influenza. Completed, enrolled 601 participants across 2 sites.

Detailed Summary

Evaluate the immune response and reactogenicity of H5N1 vaccination in adults aged 18 years and above (as part of a tetravalent vaccine)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2008
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2008
Study CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 18.4 years ago

Interventions

MF59-eTIV-H5N1+ placebo /pandemic influenza vaccinebiological

Tetravalent influenza vaccine (MF59-eTIV-H5N1)and placebo on day 1 followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1+V3.

Pandemic influenza vaccine + placebo /MF59-eTIV-H5N1biological

Pandemic influenza vaccine plus placebo on day 1 followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1+V3.

Pandemic influenza vaccine + seasonal influenza vaccine /pandemic influenza vaccinebiological

Pandemic influenza vaccine plus seasonal influenza vaccine, 3-5 weeks later pandemic influenza vaccine , including serology blood draw at V1+V3.

Pandemic influenza vaccine + placebo / MF59-eTIV-H5N1biological

Pandemic influenza vaccine plus placebo followed 3-5 weeks later by tetravalent influenza vaccine (MF59-eTIV-H5N1), including serology blood draw at V1, V2 and V3.

Pandemic influenza vaccine + seasonal influenza vaccine / pandemic influenza vaccinebiological

Pandemic influenza vaccine plus seasonal influenza vaccine followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.

MF59-eTIV-H5N1 + Placebo/pandemic influenza vaccinebiological

Tetravalent influenza vaccine (MF59-eTIV-H5N1)plus placebo followed 3-5 weeks later by pandemic influenza vaccine, including serology blood draw at V1, V2 and V3.