Stamaril Research

JRCT ID: jRCTs031180027

Registered date:17/10/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Yellow fever
• Date of first enrollment: 24/10/2018
• Target sample size: 13000
• Study type: Interventional
• Intervention(s): Injection of Stamaril Vaccine

Outcome(s)

• Primary Outcome: Safety reports after injection of Stamaril and spontaneous safety reports by participants
• Secondary Outcome: N/A

Key inclusion & exclusion criteria

• Age minimum: >= 9month old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 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 criteria

1) 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

• Primary Sponsor: Ohmagari Norio
• Source(s) of Monetary Support: Sanofi Pasteur S.A.