AnticoagulantsPhase 4NCT00222638
Influenza Vaccination and Oral Anticoagulant Therapy
A Phase 4 study testing Influenza vaccination in people with Anticoagulants and Influenza Vaccines, run by University Of Perugia at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulants, Influenza Vaccines
- What is being tested?
- Influenza vaccination
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2004to May 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OA Treatment
- Stable anticoagulation (previous two controls in range)
- Presence of indication for Influenza Vaccination
- Life expectancy > 6 months
- Signed Informed consent
Who cannot join
- Absence of stable anticoagulation
- Absence of indication for Influenza Vaccination
- Life expectancy < 6 months
- Denied Informed Consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy
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.
- Conditions
- Anticoagulants, Influenza Vaccines
- Being tested
- Influenza vaccination
- Keywords
- Oral anticoagulants, Influenza virus, Influenza vaccine, Pharmacological interference
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccinationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Variations in INR value and in OAT weekly dosage after IV
Secondary outcomes (1)
1.Efficacy of IV in patients on OAT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Investigators
- Alfonso Iorio, Principal investigator, University Of PerugiaMaria Vecchioli, Principal investigator, Regional Sanitary Agency (ASL2-Perugia)Anna Maria Iorio, Principal investigator, Institute of Virology - University of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222638
- Sponsor's protocol ID
- 04 MICV AI 01
- Status last verified
- Jun 2005
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Blinded Cross-Over Clinical Trial Investigate the Interactions Between Influenza Vaccination and Oral Anticoagulant Therapy
- ClinicalTrials.gov ID
- NCT00222638
- Acronym / sponsor ID
- 04 MICV AI 01
- Conditions
- Anticoagulants, Influenza Vaccines
- Keywords
- Oral anticoagulants, Influenza virus, Influenza vaccine, Pharmacological interference
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Oct 2004
- Study completion
- May 2005
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- OA Treatment
- Stable anticoagulation (previous two controls in range)
- Presence of indication for Influenza Vaccination
- Life expectancy > 6 months
- Signed Informed consent
Key exclusion criteria (4 listed)
- Absence of stable anticoagulation
- Absence of indication for Influenza Vaccination
- Life expectancy < 6 months
- Denied Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccination | Drug | – |
Primary outcome
1.Variations in INR value and in OAT weekly dosage after IV
1 secondary outcome
1.Efficacy of IV in patients on OAT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
- Derived from this study: PubMed 20386004Iorio 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza vaccination in people with Anticoagulants and Influenza Vaccines, run by University Of Perugia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1.Variations in INR value and in OAT weekly dosage after IV. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2005.