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Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination (MUCOFLU)

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ClinicalTrials.gov Identifier: NCT01499914
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : August 26, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis With Gastrointestinal Manifestation Biological: influenza vaccination Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 439 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)
Study Start Date : November 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Influenza vaccination
Influenza vaccination in patients with cystic fibrosis
Biological: influenza vaccination
Influenza vaccination in patients with cystic fibrosis



Primary Outcome Measures :
  1. immunogenicity of a A(H1N1)v influenza vaccine, administered in patients with cystic fibrosis [ Time Frame: Day 21 for patients vaccinated with one dose of vaccine or Day 42 for patients vaccinated with 2 doses ]

    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



Secondary Outcome Measures :
  1. Vaccination tolerance: pain, erythema, fever, other general reactions [ Time Frame: 1 year after vaccination ]
    Vaccination tolerance will be verified during all the study period

  2. Longitudinal lung function evaluation, as asses [ Time Frame: Before and 1 year after the day of vaccination ]
    FEV1, FVC recordings before and one year after the day of vaccination



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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with cystic fibrosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01499914


Locations
France
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Isabelle Sermet, MD, PhD Necker Hospital

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01499914     History of Changes
Other Study ID Numbers: P 100201
2009-016662-90 ( EudraCT Number )
First Posted: December 26, 2011    Key Record Dates
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
vaccination H1N1
cystic fibrosis

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs