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

• Conditions: Vaccination for seasonal influenza including H1N1 of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adults; MedDRA version: 12.1Level: LLTClassification code 10022000Term: Influenza

• Registration Number: EUCTR2010-022871-78-DE
• Lead Sponsor: Medizinische Hochschule Hannover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-30
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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
- Women of child-bearing potential (WOCBP) must have used an acceptable contraceptive method for at least 2 months prior to study entry until 3 weeks after vaccination:
o Female of childbearing potential is defined as a post onset of menarche or pre-menopausal female capable of becoming pregnant. This does not include females who meet any of the following conditions: (1) menopause at least 2 years earlier, (2) tubal ligation at least 1 year earlier, or (3) total hysterectomy
o Acceptable birth control methods are defined as one or more of the following:
*Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring)
*Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse
*Intrauterine device (IUD)
*Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject’s study entry

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- 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
- History of progressive or severe neurological disorders (including Guillain-Barré syndrome and convulsions, but excluding febrile convulsions)
- Subjects participating in another clinical trial and / or receiving investigational drug

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified