Safety of the Intramuscular Route of the Anti-Flu Vaccine in Patients Receiving Oral Anticoagulation Therapy

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137579
• Other study ID #: SINGRIP03
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2005
• Last updated: December 12, 2005
• Start date: September 2003
• Est. completion date: May 2004

Study information

• Verified date: January 2003
• Source: Catalan Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patients with oral anticoagulation therapy

• Patients who agree to be vaccinated

• Patients who agree to participate in the study

• Patients older than 18

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Influenza

Intervention

Procedure:
• Influenza vaccine intramuscular administration route

Locations

Country	Name	City	State
Spain	Casc Antic	Barcelona
Spain	Gotic	Barcelona
Spain	Raval Nord	Barcelona
Spain	Raval Sud	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Catalan Institute of Health

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	local pain (scores greater than 3 in the analogic visual scale of pain)
Primary	microbiologically diagnosed flu (yes/no)
Primary	International Normalized Ratio (INR) to check the interaction between the vaccine and the oral anticoagulation therapy
Secondary	increase of the arm perimeter greater than 1 cm
Secondary	local elemental skin lesions