Vaccination Against Influenza H1N1 in Rheumatic Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The spread of Influenza H1N1 has prompted the development of vaccines against this virus. Immunocompromised patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases

NCT03540823

Systemic Lupus Sjogren's Syndrome

COMPLETED PHASE4

Influenza Vaccination in Patients With Scleroderma

NCT01002508

Influenza Vaccine in Scleroderma

UNKNOWN PHASE4

H1N1sw Vaccine in Adult Transplant Recipients

NCT01069601

Immunocompromised

TERMINATED PHASE2

Immune Response to Vaccination in Patients Receiving Single Drug Immunosuppression

NCT01733056

Immunosuppression

COMPLETED NA

Intradermal Influenza Vaccination

NCT06067555

Vaccine Reaction

RECRUITING EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

100 patients with Rheumatoid Arthritis (RA), 50 patients with Systemic Lupus Erythematosus (SLE), 50 patients with spondyloarthropathies (Psoriatic arthritis (PsA) and Ankylosing Spondylitis (AS) and 200 healthy subjects will participate in the study.

All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later.

The evaluation will include:

Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.

Safety of the vaccine:

* Records of adverse event
* Assessment of disease activity : RA - Disease activity score (DAS 28), SLE - SLEDAI, PsA - DAS 28 and PASI, AS- BASDAI, ESR, CRP

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Influenza Rheumatic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Monovalent MF59-Adjuvanted vaccine

Group Type EXPERIMENTAL

Focetria (Monovalent MF59-Adjuvanted vaccine)

Intervention Type BIOLOGICAL

7.5 mcg Hemagglutinin H1/InfluezaA/California/7/2009 ,9.75 mg squalene MF59, 1.175 mg polysort80, 1.175 mg sorbitan trioleate

Intra muscular

Focetria (Monovalent MF59-Adjuvanted vaccine)

Intervention Type BIOLOGICAL

7.5 mg Hemagglutinin H1/InfluezaA/California/7/2009, 9.75 mg squalene MF59, 1.175 mg polysirate 80, 1.175 mg sorbitan trioleate

Intramuscular injection

Focetria (Monovalent MF59-Adjuvanted vaccine)

Intervention Type BIOLOGICAL

Monovalent MF59-Adjuvanted vaccine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Focetria (Monovalent MF59-Adjuvanted vaccine)

7.5 mcg Hemagglutinin H1/InfluezaA/California/7/2009 ,9.75 mg squalene MF59, 1.175 mg polysort80, 1.175 mg sorbitan trioleate

Intra muscular

Intervention Type BIOLOGICAL

Focetria (Monovalent MF59-Adjuvanted vaccine)

7.5 mg Hemagglutinin H1/InfluezaA/California/7/2009, 9.75 mg squalene MF59, 1.175 mg polysirate 80, 1.175 mg sorbitan trioleate

Intramuscular injection

Intervention Type BIOLOGICAL

Focetria (Monovalent MF59-Adjuvanted vaccine)

Monovalent MF59-Adjuvanted vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Focetria Focetria Focetria

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients suffering from: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Psoriatic Arthritis
* Able to firm an informed consent
* Aged - 18-65
* Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health