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 - Fluad Tx

Medizinische Hochschule Hannover0 sitesSeptember 30, 2010

Overview

No summary available.

Registry

who.int

Start Date

September 30, 2010

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Medizinische Hochschule Hannover

•Transplant Recipients
•\- 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
•Healthy Adults:
•\- Adult subjects 18\-60 years of age
•\- Healthy individuals as determined by medical history, physical assessment and clinical judgment of the investigator
•\- Within the same age category (\+/\- 5 years) than the incidental transplanted patient
•Transplant Recipients and Healthy Adults:
•\- Individuals who are able to comply with all study procedures and are available for all clinic visits scheduled in the study

•\- Individuals who received any vaccine within 30 days prior to study entry
•\- Individuals who received a H1N1 or seasonal influenza 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)
•\- Subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study
•\- History of or any current illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study
•\- Temperature is \= 38 °C or oral temperature \= 38\.5 °C within 3 days of intended study vaccination
•\- Administration of parenteral immunoglobulin compound – including HBIg, blood products, and/or plasma derivatives within 6 months prior to Visit 1 or planned during the full length of the study
•\- HIV infection, as previously determined or reported