Tetanus vaccine safety in patients taking anti-coagulants: can it be administered intramuscularly instead of subcutaneously, as usually recommended?

Phase 4

Completed

• Conditions: Patients treated with oral anticoagulants for whom at least one dose of anti-tetanus vaccine was indicated; Haematological Disorders; Tetanus vaccine

• Registration Number: ISRCTN69942081
• Lead Sponsor: Department of Health of Galicia (Spain)

Brief Summary

2014 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/25168768 protocol 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36619617/ (added 09/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-16
• Study Completion: 2019-06-01
• Last Update Posted: 23 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 234

Inclusion Criteria

1. All patients, whose control were being performed at 15 Health Centres (Vigo Primary Care Area)
2. Patients treated with oral anticoagulants, where administering at least one dose of anti-tetanus vaccine was indicated. This was for those whose vaccination status was unknown, uncertain or if they were clearly not vaccinated.
3. Patients giving written consent to be vaccinated and participate in the study after being duly informed.

Exclusion Criteria

1. Severe local reaction to previous doses with affection of the whole circumference of the injected limb
2. Peripheral neurological disorders due to previous doses
3. Severe anaphylactic reaction due to previous doses or any of the components
4. Bad haematologic control (INR>4) in the last 2 months
5. Serious illness, terminal stages of diseases, immobilized, adversely affected chronic pathology or immunosuppressive states
6. Pregnant or breast-feeding women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main efficacy analysis variable was the increase in anti-tetanus antibodies before/after, each route of administration (UI/ml).

Secondary Outcome Measures

Name	Time	Method
1. Measurement of the brachial perimeter in centimetres. <br>2. Appearance of elementary injuries (redness, swelling, heat, granulomas, hematoma) in the area of administration of the vaccine, axillary node, and the appearance of pain measured with the visual analogue pain scale.<br>3. The emergence of general symptoms (fever, malaise, headache, weakness, arthralgias)<br>4. The appearance of any serious adverse effect: one that was fatal or posed danger to the life of the patient, ended in disabilities or required hospitalization. <br><br>Follow-up visits at 1, 2, 14 and 30 days after each dose of the vaccine to detect any side effects.