Stamaril Research

Not Applicable

• Conditions: Yellow fever

• Registration Number: JPRN-jRCTs031180027
• Lead Sponsor: Ohmagari Norio

Brief Summary

Adverse reaction rate was lower than previous studies/reports. AEs occurred to 696 cases (6.17%) including 671 (5.95%) with or suspected causal relationship. This rate is lower than those in Stamaril(R) SmPC. The lower rate could be a result of the study conducted approximate to the normal healthcare practices. AEs occurred out of study site were reported spontaneously and was not an all case follow-up. This could have led to a lower incidence rate.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-17
• Study Completion: 2019-10-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 11287

Inclusion 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.

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety reports after injection of Stamaril and spontaneous safety reports by participants