NCT01499914

Brief Summary

Multicenter prospective cohort of approximately 1000 cystic fibrosis patients followed in the Ile de France during the 2009-2010 influenza season with the main objective to assess the effectiveness of antiviral vaccination (H1N1). All subjects will be included, without excluding factor. In particular populations at risk are additional infants 6 to 23 months, pregnant women and lung transplant will also be included. These people will be vaccinated with un-adjuvanted vaccine. If flu symptoms until the results of PCR to confirm or refute the diagnosis of influenza, oseltamivir is administered in accordance with official recommendations and based on the results of the pharmacokinetic study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
439

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 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

November 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 21, 2011

Last Update Submit

November 17, 2025

Conditions

Cystic Fibrosis With Gastrointestinal Manifestation

Keywords

vaccination H1N1cystic fibrosis

Outcome Measures

Primary Outcomes (1)

  • immunogenicity of a A(H1N1)v influenza vaccine, administered in patients with cystic fibrosis

    Immunogénicity was evaluated as: Seroprotection rate (defined by the percentage of patients with serum anti-haemagglutinin antibody titre ≥ 1/40e), seroconversion rate (defined by the percentage of patients with antibody titre \<1/10e before vaccination and ≥ 1/40e after vaccination or with a titre ≥ 1/10e before vaccination and a titre at least 4-fold greater after vaccination) and seroconversion factor (defined by the ratio of the post/pre vaccination geometric mean titres) tested 3 weeks after the last influenza vaccination

    Day 21 for patients vaccinated with one dose of vaccine or Day 42 for patients vaccinated with 2 doses

Secondary Outcomes (2)

  • Vaccination tolerance: pain, erythema, fever, other general reactions

    1 year after vaccination

  • Longitudinal lung function evaluation, as asses

    Before and 1 year after the day of vaccination

Study Arms (1)

Influenza vaccination

EXPERIMENTAL

Influenza vaccination in patients with cystic fibrosis

Biological: influenza vaccination

Interventions

influenza vaccinationBIOLOGICAL

Influenza vaccination in patients with cystic fibrosis

Influenza vaccination

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with cystic fibrosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necker Hospital

Paris, 75015, France

Location

Related Publications (3)

  • d'Alessandro E, Hubert D, Launay O, Bassinet L, Lortholary O, Jaffre Y, Sermet-Gaudelus I. Determinants of refusal of A/H1N1 pandemic vaccination in a high risk population: a qualitative approach. PLoS One. 2012;7(4):e34054. doi: 10.1371/journal.pone.0034054. Epub 2012 Apr 10.

    PMID: 22506011RESULT

  • Launay O, Boelle PY, Krivine A, Grenet D, Boussaud V, Remus N, Corvol H, Chedevergne F, Hubert D, Sermet-Gaudelus I; Inserm MUCOFLU group. Factors associated with humoral immune response to pandemic A/H1N1(v) 2009 influenza vaccine in cystic fibrosis. Vaccine. 2014 Jul 31;32(35):4515-4521. doi: 10.1016/j.vaccine.2014.06.010. Epub 2014 Jun 17.

    PMID: 24950362RESULT

  • Bucher J, Boelle PY, Hubert D, Lebourgeois M, Stremler N, Durieu I, Bremont F, Deneuville E, Delaisi B, Corvol H, Bassinet L, Grenet D, Remus N, Vodoff MV, Boussaud V, Troussier F, Leruez-Ville M, Treluyer JM, Launay O, Sermet-Gaudelus I. Lessons from a French collaborative case-control study in cystic fibrosis patients during the 2009 A/H1N1 influenza pandemy. BMC Infect Dis. 2016 Feb 1;16:55. doi: 10.1186/s12879-016-1352-2.

    PMID: 26830335DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Isabelle Sermet, MD, PhD

    Necker Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 21, 2011

First Posted

December 26, 2011

Study Start

November 1, 2009

Primary Completion

January 1, 2011

Study Completion

December 1, 2012

Last Updated

November 20, 2025

Record last verified: 2025-11

Locations

FR(1)