H1N1sw Vaccine in Adult Transplant Recipients

Phase 2

Terminated

• Conditions: Immunocompromised
• Interventions: Biological: Focetria (2x H1N1 vaccine with MF59 adjuvants)

• Registration Number: NCT01069601
• Lead Sponsor: HepNet Study House, German Liverfoundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-15
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Primary Completion: 2011-04
• Status Verified: 2012-04
• Study Completion: 2012-04
• Last Update Submitted: 2012-04-13
• Last Update Posted: 2012-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transplanted adults	Focetria (2x H1N1 vaccine with MF59 adjuvants)	male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT

Primary Outcome Measures

Name	Time	Method
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.	42 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany