Influenza Vaccination in Immunocompromized Patients

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00783380

Enrollment

304

Registered

2008-10-31

Start date

2005-10-31

Completion date

2008-03-31

Last updated

2008-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immunosuppression

Keywords

Influenza vaccination, Subunit, Virosomal, HIV/AIDS, Renal Dialysis, Kidney transplantation, Rheumatologic diseases, Immunogenicity, Reactogenicity

Brief 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.

Detailed description

The infection with influenza is associated with higher morbidity and mortality in risk groups including immunocompromized patients. The virosomal influenza vaccines have been associated with improved immunogenicity in former trials. No direct comparison with older formulations has been conducted so far.

Interventions

BIOLOGICALVirosomal influenza vaccine

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

BIOLOGICALSubunit influenza vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult outpatients treated at the Inselspital Bern for: * HIV infection * rheumatologic diseases and receiving immunosuppressive drugs * kidney transplant recipients * undergoing hemodialysis or continuous ambulatory peritoneal dialysis * written informed consent

Exclusion criteria

* Allergy to egg proteins * Former adverse reactions to prior vaccination * Febrile conditions at the time of study inclusion

Design outcomes

Primary

Measure	Time frame
Immunogenicity defined as seroconversion (1:>=4) and seroprotection rates (1:>=40)	>60 Wochen

Secondary

Measure	Time frame
Reactogenicity in rheumatologic patients by disease specific scores	Six weeks after vaccination
Immediate side effects at time of application of vaccination	Minutes after vaccination
Side effects after vaccination	First week after vaccination

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026