Immunogenicity and safety of the simultaneous administration of MR and yellow fever vaccines among Japanese adults

UMIN ID: UMIN000042738

Registered date:01/03/2021

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Yellow fever, Measles and Rubella
• Date of first enrollment: 2021/06/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Simultaneous administration of MR and yellow fever vaccines

Outcome(s)

• Primary Outcome: Immunogenicity 1)Seroprotection to yellow fever after the simultaneous administration with yelloe fever and MR vaccines
• Secondary Outcome: Safety 1)Adverse events wihin 28 days after the simultaneous administration with yelloe fever and MR vaccines Immunogenicity 2)Geometric mean titer(GMT) of yellow fever virus titer 4-6 weeks after the simultaneous administration with yelloe fever and MR vaccine 3)Seroconversion and GMTs of measles or rubella virus titers 4-6 weeks after the simultaneous administration with yelloe fever and MR vaccines

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: 1)Manifest fever (37.5 or more temperature) 2)Suffering from severe acute illness 3)History of anaphylaxis 4)Immunodeficiency 5)HIV infection 6)Immunosuppressive and Immunomodulatory Therapies 7)Neurological disorder 8)Thymus Disorder 9)History of hypersensitivity to MR and yellow fever vaccine 10)Other chronic medical conditions 11)Pregnancy 12)Brestfeeding 13)Other inappropriate condition for vaccination

Related Information

• Primary Sponsor: Tokyo Medical University Hospital Travellers' Medical Center
• Source(s) of Monetary Support: The Ministry of Education,Culuture,Sports,Science and Technology (MEXT)