MedTrace Logo

Vaccination Against Influenza H1N1 in Rheumatic Diseases

NCT01006681 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2009-11-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

Focetria (Monovalent MF59-Adjuvanted vaccine)

Monovalent MF59-Adjuvanted vaccine

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-04-30
Completion
2010-04-30

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006681 on ClinicalTrials.gov