CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 190 enrolled
Drug / intervention
Seasonal influenza vaccine available for the 2012-2013 vaccine campaigndrug
Likely dose
Seasonal influenza vaccine available for the 2012-2013 vaccine campaign 0.5mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01687517
NCT01687517Phase 3Completed

Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.

Assistance Publique - Hôpitaux de Paris·interventional·Posted Sep 19, 2012·Updated Nov 20, 2025

In Brief

A Phase 3 clinical trial evaluating Seasonal influenza vaccine available for the 2012-2013 vaccine campaign for Sarcoidosis and Influenza Vaccine. Completed, enrolled 190 participants across 1 site.

Detailed Summary

Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs, especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis patients than in the general population. Similarly, it is unclear whether the vaccine response is modified by the severity of the disease and treatment with corticosteroids and immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The demonstration of a vaccine response could allow reconsidering new vaccine approaches in sarcoidosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 19, 2012
Enrollment StartOct 1, 2012
Primary CompletionJun 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.8 years ago

Interventions

Seasonal influenza vaccine available for the 2012-2013 vaccine campaigndrug

Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)