NCT01360970|CompletedPhase 2DMC
Hepatitis A Vaccine in Patients With Immunomodulating Drugs
Hepatitis A Vaccination in Patients With Rheumatoid Arthritis Treated With TNF-inhibitors and/or Methotrexate
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Sponsor study identifier
interventional
68
2 countries
4
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Hepatitis A vaccine is the most frequently used traveller's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travellers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 2011
Actual (reported)May 2011
Actual (reported)May 24, 2011
Actual (reported)May 26, 2011
Actual (reported)seroconversion after a single dose of hepatitis A vaccine
ELISA-titers are determined before first dose and at 1 and 6 months later
one month after dose
seroconversion rates after a second dose of hepatitis A vaccine
12 monrths
1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Dept infectious diseases
Helsingfors, 00029, Finland
Dept infectious diseases
Eskilstuna, 631 88, Sweden
Dept infectious diseases
Karlstad, 651 85, Sweden
Department of infectious diseases
Stockholm, 17176, Sweden
lars rombo, MD
Karolinska Institutet
68 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2011
First Posted
May 26, 2011
Study Start
September 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2011
Actual (reported)Study Completion
May 2011
Actual (reported)Last Updated
November 18, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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