H1N1sw Vaccine in Adult Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Immunocompromised

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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transplanted adults

male and female adults who have previously undergone solid organ transplantation or allogeneic or autologous BMT

Group Type EXPERIMENTAL

Focetria (2x H1N1 vaccine with MF59 adjuvants)

Intervention Type BIOLOGICAL

7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart

Interventions

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Focetria (2x H1N1 vaccine with MF59 adjuvants)

7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart

Intervention Type BIOLOGICAL

Other Intervention Names

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Focetria(R)

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes