CClinicalTrials.gg
CompletedNCT00222638Updated Sep 22, 2005

Influenza Vaccination and Oral Anticoagulant Therapy

A Phase 4 interventional study of Influenza vaccination in Anticoagulants and Influenza Vaccines, sponsored by University Of Perugia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-22.

Sponsored by University Of Perugia · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.

02

Conditions studied

  • Anticoagulants
  • Influenza Vaccines

Browse trials for

Keywords

  • Oral anticoagulants
  • Influenza virus
  • Influenza vaccine
  • Pharmacological interference
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 100 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

University Of Perugia is the lead sponsor of 51 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Absence of stable anticoagulation
  • Absence of indication for Influenza Vaccination
  • Life expectancy \< 6 months
  • Denied Informed Consent
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single
Enrollment
100 participants

Interventions

  • DrugInfluenza vaccination
06

What researchers measure

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

07

Study locations

1 site
  • University of Perugia
    Perugia, 06100, Italy
08

References and documents

Publications

  • 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. PubMed 20386004 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00222638
Lead sponsor
University Of Perugia
First posted
Sep 22, 2005
Start date
Oct 2004
Completion
May 2005
Last update
Sep 22, 2005

Study contacts

Alfonso Iorio
principal investigator · University Of Perugia
Maria Vecchioli
principal investigator · Regional Sanitary Agency (ASL2-Perugia)
Anna Maria Iorio
principal investigator · Institute of Virology - University of Perugia
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2005. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion