Follow-up research of JVC-001 Phase III Study (Specific Clinical Research)

JRCT ID: jRCTs031230590

Registered date:24/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Not applicable
• Date of first enrollment: 24/01/2024
• Target sample size: 861
• Study type: Observational
• Intervention(s): Not applicable

Outcome(s)

Primary Outcome

1) The incidence of measles, rubella, and mumps from the time of the clinical trial vaccination until the start of this study
2) Antibody titers against measles virus, rubella virus, and mumps virus at the start of this study

• Secondary Outcome: Not applicable

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participation in the study participants who have obtained the voluntary written consent from the father, mother, grandfather, or grandmother of the study subjects and who satisfy the following inclusion criteria and do not violate the exclusion criteria are eligible.
Inclusion criteria
1) those who have been enrolled in the J301 trial and received the clinical trial vaccine
2) those who have been judged by the principal investigator or co-investigator to have no problems participating in this study

• Exclude criteria: 1) those who have received an additional dose of combined measles-rubella vaccine (MR vaccine) or mumps vaccine

Related Information

• Primary Sponsor: Shindo Shizuo
• Source(s) of Monetary Support: Daiichi Sankyo Co., Ltd.