InfluenzaPhase 4NCT00137579
Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy
A Phase 4 study testing Influenza vaccine intramuscular administration route in people with Influenza, run by Catalan Institute of Health at 4 sites in Spain.
Trial summary
Until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccine intramuscular administration route
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- How many people
- 216 participants
- Where
- 4 sitesSpain
- Study dates
- Sep 2003to May 2004
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with oral anticoagulation therapy
- Patients who agree to be vaccinated
- Patients who agree to participate in the study
- Patients older than 18
Who cannot join
- Allergy or hypersensibility to egg, chicken proteins, any component of the vaccine (neomycin, octoxinol-9 or formaldehyd)
- INR greater than 4 in the past 2 months
- Previous major bleeding
- Patients with dementia or with legal tutoring
Trial locations and contacts
4 sites in 1 country.
Spain4 sites
Raval Nord
Barcelona, Barcelona, 08001
Raval Sud
Barcelona, Barcelona, 08001
Gotic
Barcelona, Barcelona, 08002
Casc Antic
Barcelona, Barcelona, 08003
About this study
Official title: Phase IV, Simple Blind, 2-Parallel Groups Randomized Trial to Evaluate the Safety and Effectiveness of the Intramuscular Vs Subcutaneous Route for the Administration of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation
Until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. Although this practice is widely extended, no significant differences between the safety of both routes have been found. Some authors, analysing a small group of patients, affirm that the anti-flu vaccine can be administered safely by the intramuscular route on patients receiving long term oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous route without any scientific evidence. Due to this, the investigators have done a clinical trial with the aim of determining the safety and effectiveness of the flu-vaccine intramuscular route in patients receiving long term oral anticoagulation therapy and also to analyse the possible interactions between the vaccine and the oral anticoagulant treatment.
Read the detailed description
Phase IV, simple blind, 2-parallel groups, multicentric randomized trial where each patient will receive a single dose of the recommended by the WHO anti-flu vaccine for the 2003-2004 period, the control group will receive it subcutaneous and intervention group intramuscular. The assignation to each group will be randomized. The study included 4 basic areas of Barcelona city. Three visits have been scheduled for each patient: moment 0, 24 hours and 10 days after the vaccination, and a 7 month follow up period to control the incidence of the flu.
- Conditions
- Influenza
- Being tested
- Influenza vaccine intramuscular administration route
- Keywords
- Influenza Vaccines, Acenocoumarol, Drug Administration Routes, Anticoagulants
- 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 vaccine intramuscular administration routeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
local pain (scores greater than 3 in the analogic visual scale of pain)
microbiologically diagnosed flu (yes/no)
International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy
Secondary outcomes (2)
increase of the arm perimeter greater than 1 cm
local elemental skin lesions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2003
- Study completionMay 2004
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 InfluenzaStudies 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
- Parallel groups
- Masking
- Single blind
- Enrolment
- 216 participants
Sponsor and investigators
- Lead sponsor
- Catalan Institute of Health
- Sponsor type
- Other government
- Investigators
- Josep Casajuana, Physician, Principal investigator, Catalan Institute of HealthElvira Givert, Nurse, Study chair, Catalan Institute of HealthJosep Franch, Physician, Study chair, Catalan Institute of HealthClara Sala, Nurse, Study chair, Catalan Institute of HealthMiriam Aballi, Physician, Study chair, Catalan Institute of HealthBegoña Iglesias, Physician, Study chair, Catalan Institute of HealthJoan Antoni Valles, Physician, Study chair, Catalan Institute of HealthMaria del Mar Piqueras, Physician, Study chair, Catalan Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137579
- Sponsor's protocol ID
- SINGRIP03
- Status last verified
- Jan 2003
- First submitted
- 29 Aug 2005
- Last updated
- 13 Dec 2005
- Results posted
- No
Publications
Casajuana J, Iglesias B, Fabregas M, Fina F, Valles JA, Aragones R, Benitez M, Zabaleta E. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial. BMC Blood Disord. 2008 May 29;8:1. doi: 10.1186/1471-2326-8-1.
PubMed 18507871
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV, Simple Blind, 2-Parallel Groups Randomized Trial to Evaluate the Safety and Effectiveness of the Intramuscular Vs Subcutaneous Route for the Administration of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation
- ClinicalTrials.gov ID
- NCT00137579
- Acronym / sponsor ID
- SINGRIP03
- Conditions
- Influenza
- Keywords
- Influenza Vaccines, Acenocoumarol, Drug Administration Routes, Anticoagulants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants
- Lead sponsor
- Catalan Institute of HealthOther government
- Study start
- Sep 2003
- Study completion
- May 2004
- First posted
- 30 Aug 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.
Until now, the best administration route of the anti-flu vaccine for patients receiving long term oral anticoagulation therapy has been the subcutaneous one; the intramuscular route has not been recommended because it may increase the risk of muscular haematoma. Although this practice is widely extended, no significant differences between the safety of both routes have been found. Some authors, analysing a small group of patients, affirm that the anti-flu vaccine can be administered safely by the intramuscular route on patients receiving long term oral anticoagulation therapy, while a previous opinion article recommended the subcutaneous route without any scientific evidence. Due to this, the investigators have done a clinical trial with the aim of determining the safety and effectiveness of the flu-vaccine intramuscular route in patients receiving long term oral anticoagulation therapy and also to analyse the possible interactions between the vaccine and the oral anticoagulant treatment.
Detailed description
Phase IV, simple blind, 2-parallel groups, multicentric randomized trial where each patient will receive a single dose of the recommended by the WHO anti-flu vaccine for the 2003-2004 period, the control group will receive it subcutaneous and intervention group intramuscular. The assignation to each group will be randomized. The study included 4 basic areas of Barcelona city. Three visits have been scheduled for each patient: moment 0, 24 hours and 10 days after the vaccination, and a 7 month follow up period to control the incidence of the flu.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with oral anticoagulation therapy
- Patients who agree to be vaccinated
- Patients who agree to participate in the study
- Patients older than 18
Key exclusion criteria (4 listed)
- Allergy or hypersensibility to egg, chicken proteins, any component of the vaccine (neomycin, octoxinol-9 or formaldehyd)
- INR greater than 4 in the past 2 months
- Previous major bleeding
- Patients with dementia or with legal tutoring
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 vaccine intramuscular administration route | Procedure or surgery | – |
Primary outcome
local pain (scores greater than 3 in the analogic visual scale of pain)
microbiologically diagnosed flu (yes/no)
International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy
2 secondary outcomes
increase of the arm perimeter greater than 1 cm
local elemental skin lesions
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 13 Dec 2005.
- Derived from this study: PubMed 18507871Casajuana J, Iglesias B, Fabregas M, Fina F, Valles JA, Aragones R, Benitez M, Zabaleta E. Safety of intramuscular influenza vaccine in patients receiving oral anticoagulation therapy: a single blinded multi-centre randomized controlled clinical trial. BMC Blood Disord. 2008 May 29;8:1. doi: 10.1186/1471-2326-8-1.
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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.
Josep Casajuana, Physician principal investigator
Catalan Institute of Health
Elvira Givert, Nurse study chair
Catalan Institute of Health
Josep Franch, Physician study chair
Catalan Institute of Health
4 sites 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 vaccine intramuscular administration route in people with Influenza, run by Catalan Institute of Health at 4 sites in Spain.
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 4 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 13 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. 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?
local pain (scores greater than 3 in the analogic visual scale of pain). The study lists 3 primary outcomes in all. 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 NCT00137579, 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 13 Dec 2005.