Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 4:22 PM
Study NCT ID:
NCT02104869
Status:
COMPLETED
Last Update Posted:
2015-07-21
First Post:
2014-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial for the Evaluation of Three Regimens of Influenza Vaccination in Kidney Transplant Recipients
Sponsor:
Butantan Institute
Organization:
Study Overview
Official Title:
Open Label Parallel Randomized Clinical Trial to Evaluate the Immunogenicity of Three Regimens of the Trivalent Influenza Vaccine (Inactivated and Fragmented) in Kidney Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2015-07
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:
None
Brief Summary:
This will be an open label, parallel, randomized clinical trial that will evaluate the immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented) produced by Instituto Butantan among adult kidney transplant recipients, when administered in three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses administered with a 21 day interval.
The randomization ratio among the three groups of kidney transplant recipients will be 1:1, and 60 participants will be included in each group. After vaccination all participants will be followed for 26 weeks.
In addition, 15 healthy adults will be included as a control group, and will receive the recommended dose.
The study hypothesis is that a different vaccination regimen can improve the immune response of kidney transplant recipients after vaccination with the trivalent influenza vaccine (inactivated and fragmented).
The randomization ratio among the three groups of kidney transplant recipients will be 1:1, and 60 participants will be included in each group. After vaccination all participants will be followed for 26 weeks.
In addition, 15 healthy adults will be included as a control group, and will receive the recommended dose.
The study hypothesis is that a different vaccination regimen can improve the immune response of kidney transplant recipients after vaccination with the trivalent influenza vaccine (inactivated and fragmented).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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 |
|---|---|---|---|---|
| U1111-1155-2836 | OTHER | WHO-UTN | View |