H1N1sw Vaccine in Adult Transplant Recipients

HepNet Study House, German Liverfoundation

Status and phase

Terminated

Phase 2

Conditions

Immunocompromised

Treatments

Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01069601

200910H1N1MHH (Other Identifier)

2009-017052-27

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)