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

Phase 4

Recruiting

• Conditions: Prevention of Yellow fever, Measles and Rubella; Yellow fever, Measles, Rubella

• Registration Number: JPRN-jRCT1031210111
• Lead Sponsor: FUKUSHIMA SHINJI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity<br>1) Seroprotection rate to yellow fever after the simultaneous administration with yelloe fever and MR vaccines

Secondary Outcome Measures

Name	Time	Method
Safety<br>1)Adverse events wihin 28 days after the simultaneous administration with yelloe fever and MR vaccines<br>Immunogenicity<br>2)Geometric mean titer(GMT) of yellow fever virus titer 4-6 weeks after the simultaneous administration with yelloe fever and MR vaccine<br>3)Seroconversion rate and GMTs of measles or rubella virus titers 4-6 weeks after the simultaneous administration with yelloe fever and MR vaccines