Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-01 @ 4:52 PM
Study NCT ID:
NCT01086904
Status:
COMPLETED
Last Update Posted:
2012-01-02
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients
Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Organization:
Study Overview
Official Title:
Etude de Phase II évaluant l'immunogénicité et la tolérance d'un Vaccin inactivé Non adjuvanté Contre la Grippe A (H1N1) après Transplantation rénale
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Transfluvac
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-016659-23 | EUDRACT_NUMBER | None | View |