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

NCT01499914 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 439

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis With Gastrointestinal Manifestation

Interventions

BIOLOGICAL

influenza vaccination

Influenza vaccination in patients with cystic fibrosis

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Isabelle Sermet, MD, PhD · Necker Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-01-31
Completion
2012-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01499914 on ClinicalTrials.gov