Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-24 @ 9:22 PM
NCT ID:
NCT01086904
Brief Summary:
The study is aimed at assessing the safety and efficacy of an inactivated and non adjuvanted Influenza A (H1N1) vaccine in renal transplant recipients.
Detailed Description:
120 renal transplant recipients under triple immunosuppression will be immunized against influenza H1N1v.
The primary endpoint will be the humoral immunity assessed 21 days after each injection on day 0 and day 21:
* seroprotection rate, defined as the percentage of patients with an antibody title against Hemaglutinin ≥ 1/40e after immunization
* seroconversion rate, defined as the the percentage of patients with an antibody title against Hemaglutinin \< 1/10e before immunization and ≥ 1/40e after or with a prevaccine title ≥1/10e increasing at least 4 fold after immunization
* seroconversion factor, defined as the ratio between pre and post vaccine geometrical means of the antibody titles.
Secondary endpoints will be:
* Seroconversion rate, seroprotection rate and seroconversion factor on day 182
* Percentage of patients with an antibody title \> 1/40e on day 182 (Immune memory)
* Number and severity of clinical and biological adverse events
* Number of cases of pandemic H1N1v influenza virologically confirmed
* Study of associated parameters influencing the results of H1N1v vaccination in terms of seroprotection, seroconversion and seroconversion factor
* Assessment of the cellular immune response against H1N1v
* Assessment of the H1N1v vaccination on graft function and on humoral anti-HLA response.
Study:
NCT01086904
Study Brief:
Protocol Section:
NCT01086904