H1N1sw Vaccine in Adult Transplant Recipients

Immunocompromised Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01069601
• Other study ID #: 2009-017052-27
• Secondary ID: 200910H1N1MHH
• Status: Terminated
• Phase: Phase 2
• First received: February 15, 2010
• Last updated: April 13, 2012
• Start date: February 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: HepNet Study House, German Liverfoundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Agency for Sera and Vaccines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Immunocompromised

Intervention

Biological:
• Focetria (2x H1N1 vaccine with MF59 adjuvants)
7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
HepNet Study House, German Liverfoundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes