clinical trial to evaluating efficacy of a double dose of seasonal flu vaccine compared to single dose for prevention of influenza in solid organ transplant recipients

Phase 1

• Conditions: seasonal influenza prophylaxis in trasplant receipiens; MedDRA version: 14.0Level: LLTClassification code 10021829Term: Infection in solid organ transplant recipientsSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-003243-21-ES
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-09
• Study Completion: 2016-07-28
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 499

Inclusion Criteria

1. solid organ transplant receipation.
2. 16 years or older.
3. More than 30 days after transplantation.
4. Negative pregnancy test for women of childbearing age
5. The patient must give informed consent
Are the trial subjects under 18? yes
Number of subjects for this age range: 46
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. No written informed consent.
2. Acute rejection within 15 days prior to vaccination.
3. Pregnancy.
4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified