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

HepNet Study House, German Liverfoundation1 site in 1 country122 target enrollmentNovember 2010

ConditionsImmunocompromised Transplanted

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Immunocompromised
Sponsor: HepNet Study House, German Liverfoundation
Enrollment: 122
Locations: 1
Primary Endpoint: Seroconversion and Seroprotection after 21 days
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

April 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

HepNet Study House, German Liverfoundation

Responsible Party

Sponsor

Eligibility 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

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

Outcomes

Primary Outcomes

Seroconversion and Seroprotection after 21 days

Time Frame: 21 days

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 (as outlined above). This study is successful, if all three point estimates pass the corresponding efficacy criteria at day 21. For descriptive purpose two-sided 95%-confidence intervals for the rates and the GMR at day 21 will be presented.

Secondary Outcomes

comparison of vaccine efficacy in transplanted versus healthy subjects(21 and 42 days)
assessment of primary and secondary outcomes with the two other strains(21 and 42 days)
safety issues as number of participants with adverse events(21 and 42 days and 9 months)