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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01499914
First received: November 21, 2011
Last updated: September 14, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Cystic Fibrosis With Gastrointestinal Manifestation
 Biological: influenza vaccination
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cystic Fibrosis Flu
U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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:
  • Vaccination tolerance: pain, erythema, fever, other general reactions [ Time Frame: 1 year after vaccination ] [ Designated as safety issue: Yes ]
    Vaccination tolerance will be verified during all the study period

  • Longitudinal lung function evaluation, as asses [ Time Frame: Before and 1 year after the day of vaccination ] [ Designated as safety issue: No ]
    FEV1, FVC recordings before and one year after the day of vaccination


Enrollment: 458
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccination
Influenza vaccination in patients with cystic fibrosis
 Biological: influenza vaccination
Influenza vaccination in patients with cystic fibrosis
Other Name: influenza vaccination

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with cystic fibrosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01499914     History of Changes
Other Study ID Numbers: P 100201, 2009-016662-90
Study First Received: November 21, 2011
Last Updated: September 14, 2012
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Influenza, Human
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
 Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 19, 2013