NCT00222638

Brief Summary

The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

September 22, 2005

Status Verified

June 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

AnticoagulantsInfluenza Vaccines

Keywords

Oral anticoagulantsInfluenza virusInfluenza vaccinePharmacological interference

Outcome Measures

Primary Outcomes (1)

  • 1.Variations in INR value and in OAT weekly dosage after IV

Secondary Outcomes (1)

  • 1.Efficacy of IV in patients on OAT

Interventions

Influenza vaccinationDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OA Treatment
  • Stable anticoagulation (previous two controls in range)
  • Presence of indication for Influenza Vaccination
  • Life expectancy \> 6 months
  • Signed Informed consent

You may not qualify if:

  • Absence of stable anticoagulation
  • Absence of indication for Influenza Vaccination
  • Life expectancy \< 6 months
  • Denied Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Perugia

Perugia, Perugia, 06100, Italy

Location

Related Publications (1)

  • Iorio A, Basileo M, Marcucci M, Guercini F, Camilloni B, Paccamiccio E, Vecchioli M, Iorio AM. Influenza vaccination and vitamin K antagonist treatment: a placebo-controlled, randomized, double-blind crossover study. Arch Intern Med. 2010 Apr 12;170(7):609-16. doi: 10.1001/archinternmed.2010.49.

    PMID: 20386004DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Alfonso Iorio

    University Of Perugia

    PRINCIPAL INVESTIGATOR

  • Maria Vecchioli

    Regional Sanitary Agency (ASL2-Perugia)

    PRINCIPAL INVESTIGATOR

  • Anna Maria Iorio

    Institute of Virology - University of Perugia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Study Completion

May 1, 2005

Last Updated

September 22, 2005

Record last verified: 2005-06

Locations

IT(1)