At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 304 enrolled

Drug / intervention

Virosomal influenza vaccine +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/NCT00783380

NCT00783380Phase 4Completed

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Double Blind Randomized Comparison of a Subunit- and a Virosomal Influenza Vaccine in Immunocom-Promized Patients

Insel Gruppe AG, University Hospital Bern·interventional·Posted Oct 31, 2008·Updated Nov 3, 2008

In Brief

A Phase 4 clinical trial evaluating Virosomal influenza vaccine and Subunit influenza vaccine for Immunosuppression. Completed, enrolled 304 participants across 3 sites.

Detailed Summary

Evaluation of the immunogenicity and reactogenicity of two different formulations of commercially avail-able influenza vaccines in 4 different groups of immunocompromized outpatients (HIV positive patients, patients suffering from rheumatologic diseases and receiving treatment with immunosuppressive drugs and patients undergoing hemodialysis or continuous ambulatory peritoneal dialysis). The aim of the study was to investigate if the newest formulation of influenza vaccines (virosomal vaccines) offer a benefit in immunocompromized patients in comparison to an older subunit formulation.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsImmunosuppression

CountriesSwitzerland

CollaboratorsBoehringer Ingelheim, Abbott, Merck Sharp & Dohme LLC, Solvay Pharmaceuticals

Timeline

Phase 4CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartOct 2005

Primary CompletionJul 2006

Study CompletionMar 2008

First PostedOct 2008

TodayJul 2026

First PostedOct 31, 2008

Enrollment StartOct 1, 2005

Primary CompletionJul 1, 2006

Study CompletionMar 1, 2008

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 17.7 years ago

Interventions

Virosomal influenza vaccinebiological

Influvacplus 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients

Subunit influenza vaccinebiological

Influvac 2005/2006, Solvay Pharma AG, Bern, Switzerland Assigned to all 4 groups if immunocompromized patients