A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a H1N1 Influenza Vaccine in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers

HepNet Study House, German Liverfoundation1 site in 1 country13 target enrollmentFebruary 2010

ConditionsImmunocompromised

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Immunocompromised
Sponsor: HepNet Study House, German Liverfoundation
Enrollment: 13
Locations: 1
Primary Endpoint: The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents.
Status: Terminated
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The trial investigates the efficacy of the adjuvanted H1N1 influenza vaccine Focetria(R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered twice the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

April 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HepNet Study House, German Liverfoundation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult subjects 18-60 years of age who have undergone prior renal, cardiac, liver, lung, or bone marrow transplantation for any reason, more than 3 months prior to enrolment
•Patients able to visit the outpatient clinic with a life expectancy of at least one year
•Patients who receive any immunosuppressive treatment currently taken to prevent organ rejection

Exclusion Criteria

•Individuals who received any vaccine within 30 days prior to study entry
•Individuals who received a H1N1 vaccination less than 6 months prior to the study
•Influenza diagnosed by a physician within 4 months prior to the study start
•Pregnant or lactating females
•History of an anaphylactic (i.e. life-threatening) reaction to any of the components of the vaccines, including egg and chicken proteins, ovalbumin, kanamycin and neomycin sulphate, formaldehyde and cetyltrimethylammonium bromide (CTAB)

Outcomes

Primary Outcomes

The adjuvanted H1N1 influenza vaccine, when administered twice in transplanted patients, fulfils all serological efficacy criteria as required for the elderly population (aged 60 and older) according to the respective European guidance documents.

Time Frame: 42 days

Secondary Outcomes

The adjuvanted H1N1 influenza vaccine in transplanted patients, when administered twice, is at least as effective as the adjuvanted H1N1 influenza vaccine in the healthy volunteers after only one administration.(42 days)