Vaccination for seasonal influenza including H1N1 of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adults MedDRA version: 12.1 Level: LLT Classification code 10022000 Term: Influenza
Conditions
Interventions
Trade Name: FLUAD® Influenza Vaccine Surface Antigen, Inactivated, Adjuvanted with MF59C
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: INFLUENZA VACCINE
Concentra
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The H1N1 vaccine (included in the trivalent influenza vaccine) when administered twice in transplanted patients, fulfils all serological efficacy criteria at day 21 as required for the elderly population (aged 60 and older) according to the respective European guidance documents. These criteria are 30% for seroconversion rate, 60% for seroprotection rate and 2 for geometric mean ratio (GMR).;Secondary Objective: Main 1.Immune response (IR) of H1N1 vacc is at least as effective in Tx patients as in healthy volunt. Non-inferiority-margin of 0.45 for ratio of geometric mean titers (GMT) of Tx patients&age-matched healthy volunteers (AMHV) (day 21) is used 2.Primary&1st main sec.obj. are evaluated for the other 2 virus strains of trivalent vacc For each virus strain: -Serological efficacy criteria (SEC) for elderly in guidance documents are fulfilled for Tx patients (days 42,280) -Comparison of SEC (seroprotection, seroconversion rates) betw. Tx patients&AMHV -SEC in guidance documents are fulfilled for AMHV (days 21,42,280). Criteria: 40%(seroconv rate), 70%(seroprot rate), 2.5(GMR) -Comparison of IR in relation to immunosuppr. med. in Tx subjects -All serol. assessments&group comparisons measured by microneutralization for Tx patients&AMHV are performed in line with HI analyses (all timepoints). Comparison of safety of triv. vacc overall, and in Tx patients&AMHV ;Primary end point(s): The observed percentage of seroconversion and seroprotection, as well as the observed GMR (measured by HI) in transplanted patients at day 21 will be compared with the thresholds from the guideline for adults aged over 60. This study is successful, if all three point estimates pass the corresponding efficacy criteria at day 42. For descriptive purpose two-sided 95%-confidence intervals for the rates and the GMR at day 42 will be presented. | — |
Countries
Germany
Outcome results
None listed