NCT01065285

Brief Summary

The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
234

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

November 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

October 21, 2009

Last Update Submit

November 17, 2025

Conditions

Autoimmune Diseases

Keywords

Influenzaautoimmune diseasesvaccinationH1N1

Outcome Measures

Primary Outcomes (1)

  • Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection

    Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection

    3 weeks

Secondary Outcomes (9)

  • Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment (comparison of patients treated by immunosuppressants or not treated)

    3 weeks

  • Number of side effects related to vaccination

    3 weeks

  • Number of local side effects related to vaccination (erythema and/or pain at injection site)

    3 weeks

  • Number of patients who will develop influenza despite vaccination

    3 weeks

  • Number of patients who had antibodies against H1N1 before vaccination

    3 weeks

  • +4 more secondary outcomes

Study Arms (1)

Evaluation of vaccines against flu

EXPERIMENTAL

Evaluation of vaccines against flu

Biological: Evaluation of vaccines against flu

Interventions

Evaluation of vaccines against fluBIOLOGICAL

evaluate efficacy and tolerance

Also known as: Evaluation of vaccines against flu in auto-imune diseases
Evaluation of vaccines against flu

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients presenting autoimmune and systemic diseases,
  • treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups)

You may not qualify if:

  • Absence of informed consent
  • Disease which did not responded to the above criteria
  • Active infection at time of vaccination
  • HIV infection
  • History of Guillain-Barre syndrome
  • Allergy to one component of the vaccine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Cochin

Paris, 75014, France

Location

Related Publications (1)

  • Kostianovsky A, Charles P, Alves JF, Goulet M, Pagnoux C, Le Guern V, Mouthon L, Krivine A, Villiger P, Launay O, Guillevin L; French Vasculitis Study Group. Immunogenicity and safety of seasonal and 2009 pandemic A/H1N1 influenza vaccines for patients with autoimmune diseases: a prospective, monocentre trial on 199 patients. Clin Exp Rheumatol. 2012 Jan-Feb;30(1 Suppl 70):S83-9. Epub 2012 May 11.

    PMID: 22640652RESULT

MeSH Terms

Conditions

Autoimmune DiseasesInfluenza, Human

Condition Hierarchy (Ancestors)

Immune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Loïc GUILLEVIN, MD PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

February 9, 2010

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

February 1, 2012

Last Updated

November 20, 2025

Record last verified: 2025-10

Locations

FR(1)