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Effect of the Interferon Alpha Citizen by Sub-Lingual Way on the Humoral Immunizing Answer

NCT00647465 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2008-03-31

No results posted yet for this study

Summary

Influenza vaccination reduces the morbidity and mortality associated with influenza infection in at risk groups including the elderly and individuals with an impaired immune response, but is not totally protective in all recipient. Cytokines including type I interferons are known to play a key role in the innate immune response to virus infection and in the induction of the primary adaptive-immune response. Thus, we evaluated the safety of sublingual administration of IFNa and its effect on immune response to influenza vaccination in a randomized double-blind placebo controlled study in elderly institutionalized individuals.

Conditions

  • Influenza Infection

Interventions

DRUG

vaccine

IFNalpha 2b

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Orakine Ltd, Dublin, Ireland

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Frederic Bloch, MD, PhD · Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1 AP-HP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-05-31
Completion
2008-03-31

Countries

  • France

Study Locations

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Entities

Drugs

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 NCT00647465 on ClinicalTrials.gov