NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031180027

Registered date:17/10/2018

Stamaril Research

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedYellow fever
Date of first enrollment24/10/2018
Target sample size13000
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Injection of Stamaril Vaccine

Outcome(s)

Primary OutcomeSafety reports after injection of Stamaril and spontaneous safety reports by participants
Secondary OutcomeN/A

Key inclusion & exclusion criteria

Age minimum>= 9month old
Age maximumNot applicable
GenderBoth
Include criteria1) Person who may be exposed to the risk of yellow fever 2) Person aged 9 months or older on the day of vaccination with Stamaril 3) Person who gave written consent to get vaccinated with Stamaril which is unapproved in Japan, as an alternative to Yellow Fever Vaccine. 4) For persons aged 16 to less than 20 years, written consent from their legal representative is also needed in addition to written consent from the participant. 5) For persons aged less than 16 years, written consent from their legal representative is needed. 6) For persons aged 6 months to less than 9 months, persons who are or are possibly pregnant, persons aged 60 years or older, and persons infected with asymptomatic human immunodeficiency virus not associated with immune dysfunction, their doctor should judge that the expected benefits of vaccination outweigh the risks.
Exclude criteria1) Person with hypersensitivity to any of the additives contained in Stamaril, chicken eggs, or chicken meat proteins 2) Person with congenital or acquired immunodeficiency, such as those receiving immunosuppressive therapy with chemotherapy, systemic administration of corticosteroids, etc. 3) Person with a history of thymic dysfunction (including myasthenia gravis, thymoma, and thymectomy) 4) Person infected with symptomatic human immunodeficiency virus 5) Person infected with asymptomatic human immunodeficiency virus associated with immune dysfunction 6) Person with fever (more than 37.5 degrees) 7) Person who is judged by the doctor to have severe acute disease 8) Breastfeeding women who cannot suspend breastfeeding for at least 14 days after vaccination with Stamaril 9) Other persons who are judged by their doctor to be not appropriate for getting vaccinated prophylactically

Related Information

Contact

Public contact
Name Mugen Ujie
Address 1-21-1 Toyama, Shinjuku-ku Tokyo Japan 162-8655
Telephone +81-3-3202-7181
E-mail mgujiie@hosp.ncgm.go.jp
Affiliation National Center for Global Health and Medicine
Scientific contact
Name Norio Ohmagari
Address 1-21-1 Toyama, Shinjuku-ku Tokyo Japan 162-8655
Telephone +81-3-3202-7181
E-mail nohmagari@hosp.ncgm.go.jp
Affiliation National Center for Global Health and Medicine