H1N1sw Vaccine in Adult Transplant Recipients

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

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.

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)