NCT01002716

Brief Summary

The efficacy of vaccination against influenza in patients with rheumatoid arthritis has been assessed using humoral response. However, the cellular immunity is another important pathway of response to vaccination. The purpose of this study is to evaluate the degree of cellular immunity response to influenza vaccination. Patient with rheumatoid arthritis and healthy controls will participate in this study , will undergo a clinical evaluation the day of vaccination and 4 weeks after. The humoral and cell immunity response will be assessed the day of vaccination and 4 weeks later

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
90

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4 rheumatoid-arthritis

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

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 27, 2009

Status Verified

October 1, 2009

Enrollment Period

5 months

First QC Date

October 15, 2009

Last Update Submit

October 26, 2009

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid influenza vaccine cell immunity

Outcome Measures

Primary Outcomes (1)

  • Cell immunity response

    4 weeks

Secondary Outcomes (1)

  • Safety of influenza vaccination

    4 weeks

Interventions

Agrippal S1 (Influenza vaccination)BIOLOGICAL

Single dose of vaccine

Also known as: Agripal S1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rheumatoid arthritis

You may not qualify if:

  • Allergy to egg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Ori Elkayam, MD

CONTACT

97236973668orie@tasmc.health.gov.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 15, 2009

First Posted

October 27, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

October 27, 2009

Record last verified: 2009-10

Locations

IL(1)