NCT01002508

Brief Summary

The safety and efficacy of vaccination against influenza in patients with scleroderma is not clear. The objective of this study is to assess its safety and efficacy in 50 patients with scleroderma in comparison with 30 controls

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 27, 2009

Status Verified

August 1, 2009

Enrollment Period

4 months

First QC Date

October 26, 2009

Last Update Submit

October 26, 2009

Conditions

Influenza Vaccine in Scleroderma

Keywords

influenza vaccine scleroderma immunogenicity safety

Outcome Measures

Primary Outcomes (1)

  • The number of subjects who achieve a titer of antibodies above 1/40

    6 weeks

Secondary Outcomes (1)

  • Number of patients with an increased Rodnan Score

    6 weeks

Interventions

Influenza vaccineBIOLOGICAL

One dose of influenza vaccine

Eligibility Criteria

Age16 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients \>18 year old age
  • Capable to sign a informed consent
  • Suffering from scleroderma

You may not qualify if:

  • Known allergy to influenza vaccine
  • Allergy to eggs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • Setti M, Fenoglio D, Ansaldi F, Filaci G, Bacilieri S, Sticchi L, Ferrera A, Indiveri F, Ghio M. Flu vaccination with a virosomal vaccine does not affect clinical course and immunological parameters in scleroderma patients. Vaccine. 2009 May 26;27(25-26):3367-72. doi: 10.1016/j.vaccine.2009.01.078. Epub 2009 Feb 5.

    PMID: 19200840BACKGROUND

MeSH Terms

Interventions

Influenza Vaccines

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Ira Litinsky, MD

CONTACT

97236873668orie@tasmc.health.gov.il

Ori Elkayam, M.D

CONTACT

97236973668oribe14@netvision.net.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 27, 2009

Record last verified: 2009-08

Locations

IL(1)