Seasonal Flu Vaccine in Adult Transplant Recipients (Fluad Tx)
|ClinicalTrials.gov Identifier: NCT01258023|
Recruitment Status : Completed
First Posted : December 10, 2010
Last Update Posted : April 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Immunocompromised Transplanted||Biological: Fluad 1x||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||April 2012|
Experimental: transplant recipients
Immunocompromised Adults Who Have Undergone Solid Organ Transplantation or Bone Marrow Transplantation
Biological: Fluad 1x
15 µg antigen/strain:
- 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.
- comparison of vaccine efficacy in transplanted versus healthy subjects [ Time Frame: 21 and 42 days ]1. The immune response of the H1N1 vaccine is at least as effective in transplanted patients as in the healthy volunteers after one administration. For orientation in the assessment a non-inferiority-margin of 0.45 for the ratio of the geometric mean titers (GMTs) of transplanted patients and age-matched healthy volunteers at day 21 will be used and reflects what can be demonstrated with given sample size.
- assessment of primary and secondary outcomes with the two other strains [ Time Frame: 21 and 42 days ]The primary and the first main secondary objective will also be evaluated for the other two virus strains (H3N2 and type B) of the trivalent vaccination.
- safety issues as number of participants with adverse events [ Time Frame: 21 and 42 days and 9 months ]The safety of the study vaccine will be analyzed based on number of subjects exposed to the vaccine with respect to (1) solicited events within 7 days after injection; and (2) non-solicited adverse events at least 21 days after injection. Unsolicited events will include SAEs, AEIs (e.g. neuritis, convulsions, severe allergic reactions, angioedema, non-infectious encephalitis, vasculitis, Guillain-Barrè syndrome, demyelination, Bell's palsy), all other non-solicited AEs, which are routinely collected including onset of chronic diseases.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258023
|Medical School Hannover|
|Hannover, Germany, 30625|