H1N1sw Vaccine in Adult Transplant Recipients

This study has been terminated.

(End of H1N1 Swine Flu Pandemic)

Sponsor:

Information provided by (Responsible Party):

HepNet Study House, German Liverfoundation

ClinicalTrials.gov Identifier:

NCT01069601

First received: February 15, 2010

Last updated: April 13, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 15, 2010

Last Updated Date

April 13, 2012

Start Date ^ICMJE

February 2010

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01069601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

H1N1sw Vaccine in Adult Transplant Recipients

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Immunocompromised

Intervention ^ICMJE

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

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

Other Name: Focetria(R)

Study Arm (s)

Experimental: transplanted adults

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

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2012

Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01069601

Other Study ID Numbers ^ICMJE

2009-017052-27, 200910H1N1MHH

Has Data Monitoring Committee

Yes

Responsible Party

HepNet Study House, German Liverfoundation

Study Sponsor ^ICMJE

HepNet Study House, German Liverfoundation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael P Manns, Prof

Hannover Medical School

Information Provided By

HepNet Study House, German Liverfoundation

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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