E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Vaccination for H1N1sw of immunocompromised adults who have undergone solid organ or bone marrow transplantation and of healthy adults |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022000 |
E.1.2 | Term | Influenza |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is that for transplanted patients the adjuvanted H1N1 influenza vaccine, when administered twice, fulfils all serological efficacy criteria 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 GMR. |
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E.2.2 | Secondary objectives of the trial |
- The vaccine in transplanted patients (administered twice) is at least as effective as the vaccine in the healthy volunteers (administrated once). -The serological efficacy criteria as outlined for the elderly in the European guidance documents are fulfilled for transplanted patients at day 21 and 280. -Comparison of the serological efficacy criteria seroprotection and seroconversion rates between transplanted patients and age-matched healthy volunteers. -The serological efficacy criteria as outlined in the European guidance documents are fulfilled for matched healthy volunteers at day 21,42 and 280. These criteria are 40% for seroconversion rate, 70% for seroprotection rate and 2.5 for GMR. -Comparison of immune response in relation to immunosuppressive medication in transplant subjects. -All serological assessments and group comparisons measured by MN for transplanted patients and age-matched healthy volunteers will be performed in line with HI analyses at all time points.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 last 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
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E.4 | Principal 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) - 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
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E.5 End points |
E.5.1 | Primary end point(s) |
The observed percentage of seroconversion and seroprotection rates, as well as the observed GMR (measured by HI) in transplanted patients at day 42 will be compared with the thresholds from the guideline for adults, aged over 60 (as outlined above). 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |