NCT01258023

Seasonal Flu Vaccine in Adult Transplant Recipients

A Phase II Study to Evaluate the Immunogenicity, Safety and Tolerability of a Seasonal Influenza Vaccine Including H1N1 in Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation and in Age-Matched Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: HepNet Study House, German Liverfoundation · Network
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The trial investigates the efficacy of adjuvanted seasonal influenza including H1N1 Fluad (R) in immunocompromised adults who have undergone solid organ or bone marrow transplantation. It is expected that when administered once the vaccine fulfills all serological efficacy criteria required for the elderly population age 60 years and older.

Conditions

• Immunocompromised
• Transplanted

Interventions

Type	Name	Description
BIOLOGICAL	Fluad 1x	15 µg antigen/strain: * A/California/07/2009 (H1N1) - like strain * A/Perth/16/2009 (H3N2) - like strain * B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2010-12-10
• Last updated: 2012-04-16

Locations

1 site across 1 country: Germany