A Phase II Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Immunogenicity of V212 in Adult Patients with Autoimmune Disease - V212 in Adult Patients with Autoimmune Disease

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 340 人开始时间: 2012年2月16日最近更新: 2013年4月29日

试验速览

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•Patient is =18 years of age with an autoimmune disease, has clinically stable disease for =30 days prior to enrollment, is receiving treatment with at least one biologic agent or non-biologic therapy at a stable dose for =3 months, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for =30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, and is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 204
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 136

•Patient has a history of herpes zoster within 1 year of enrollment, has a history of receipt of any varicella or zoster vaccine, has or will receive treatment with any anti-CD20 monoclonal antibody within the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is likely to receive any live virus vaccine during the period from 4 weeks prior to enrollment through 28 days following the last dose of study vaccine, or is likely to receive any inactivated vaccine during the period from 7 days prior to, through 7 days following, any dose of study vaccine.

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