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

JRCT ID: jRCT1031210111

Registered date:25/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of Yellow fever, Measles and Rubella
• Date of first enrollment: 25/05/2021
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1) Simultaneous administration of MR and yellow fever vaccines
2) Measurement of antibody titers against yellow fever, measles and rubella

Outcome(s)

Primary Outcome

Immunogenicity
1) Seroprotection rate 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 rate 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: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

1) Japanese healthy adults who need MR and yellow fever vaccines
2) 20 years old and over and under 60 years old
3) No history of yellow fever
4) No history of immunization of yellow fever vaccine

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: FUKUSHIMA SHINJI
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research(C)
• Secondary ID(s): UMIN000042738