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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 15, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 19, 2026

Status Verified

July 1, 2010

Enrollment Period

2 months

First QC Date

November 16, 2009

Last Update Submit

February 16, 2026

Conditions

Renal Transplant RecipientsImmunosuppression

Keywords

renal transplantationimmunosuppressioninflenza A (H1N1)vaccine

Outcome Measures

Primary Outcomes (1)

  • Specific humoral response 21 days after each administration Seroprotection and seroconversion rates

    after each vaccination and at 6 months

Secondary Outcomes (1)

  • Seroprotection and seroconversion rates at day 182;Percentage of patients with anti-H1N1v Antibodies >1/40e at day 182; Number of undesired events and of Influenza A cases; Assessment of cellular immune response against Influenza A H1N1; Effect of vacc

    6 months

Study Arms (1)

Kidney transplant patients

EXPERIMENTAL

Patients included in urology and nephrology departments for : a first deep subcutaneous or intramuscular administration of the H1N1 vaccine on day 0, followed by a second deep subcutaneous or intramuscular administration of the H1N1 vaccine on day 21.

Biological: inactivated non adjuvanted pandemic H1N1 vaccine

Interventions

inactivated non adjuvanted pandemic H1N1 vaccineBIOLOGICAL

two administrations at D and D21 (15 µg HA)

Kidney transplant patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age \> 18 and \< 60 years old
  • Signed information consent
  • Social security coverage
  • Renal transplantation \> 6 months with a creatinine clearance \> 20 ml/mn
  • Stable renal function defined as serum creatinine variation \< 20 % for the last three months
  • Receiving a triple immunosuppression regimen including steroids, Calcineurine inhibitors (cyclosporine or Tacrolimus), and IMPDH inhibitors (Mycophenolate Mofetil or mycophenolic acid)
  • Regular follow-up
  • For child bearing aged female:
  • Negative urinary HCG
  • Contraception during the first three months of the study

You may not qualify if:

  • Poor renal function defined as creatinine clairance \< 20 ml/mn
  • Unstable renal function defined as serum creatinine variations \> 20 % during the last 3 months
  • Known HIV, HBV or HCV infection
  • Known allergy to egg proteins or to one the vaccine compounds
  • Severe adverse events after prior administration of any influenza vaccine
  • Multiple sclerosis
  • Past history of Guillain Barre syndrome
  • H1N1 influenza episode with positive virological tests during the last 6 months
  • Cancer requiring radiotherapy or chemotherapy during the last 6 months
  • Blood transfusion during the last 3 months
  • Pregnancy during the last 3 months
  • No follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre hospitalier Lyon Sud, service de néphrologie transplantation

Pierre-Bénite, Lyon, 69495, France

Location

Hôpital E. Herriot , Service de néphrologie, transplantation et immunologie clinique

Lyon, 69437, France

Location

Service d'urologie, GH Pitié Salpêtrière

Paris, 75013, France

Location

Related Publications (1)

  • Le Corre N, Thibault F, Pouteil Noble C, Meiffredy V, Daoud S, Cahen R, Charreau I, Bottigioli D, Dollinger C, Aboulker JP, Autran B, Morelon E, Barrou B. Effect of two injections of non-adjuvanted influenza A H1N1pdm2009 vaccine in renal transplant recipients: INSERM C09-32 TRANSFLUVAC trial. Vaccine. 2012 Dec 14;30(52):7522-8. doi: 10.1016/j.vaccine.2012.10.047. Epub 2012 Oct 25.

    PMID: 23103195RESULT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

March 15, 2010

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

May 1, 2010

Last Updated

February 19, 2026

Record last verified: 2010-07

Locations

FR(3)