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Post-marketing clinical trial to confirm antibody titers against measles and rubella virus before the 2nd routine immunization for people who participated in L0131 study

Post-marketing clinical trial to confirm antibody titers against measles and rubella virus before the 2nd routine immunization for people who participated in L0131 study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
JPRN
Registry ID
JPRN-jRCT2031240750
Enrollment
210
Registered
2025-03-27
Start date
2025-04-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of measles and rubella

Interventions

None listed

Sponsors

Mika Oshio
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Born between April 2, 2019 and April 1, 2020, and joined L0131 study at 1st routine immunization and got thier antibody titer measured after the vaccination 2) Assent given by the subjects and Infomed consent signed by their parents or gurdians

Exclusion criteria

Exclusion criteria: 1) Received booster dose of vaccine prepared from measles virus and/or rubella virus 2) Received a blood transfusion or gamma-globulin preparation within 12 weeks (Day -84), or high-dose therapy of gamma-globulin preparation (200 mg/kg/day or more) within 24 weeks (Day -168) prior to the blood sampling 3) PI(SI) identified as Not eligiable to participate in the study

Design outcomes

Primary

MeasureTime frame
1) Seropositive rate of neutralizing antibody against measles virus and hemagglutination inhibition (HI) antibody against rubella

Secondary

MeasureTime frame
1) Geometric mean antibody titers of neutralizing antibody against measles virus and hemagglutination inhibition (HI) antibody against rubella 2) Transition of neutralizing antibody titer aginst measles virus and hemagglutination inhibition (HI) antibody titer against rubella from the post of 1st vaccination to the pre of 2nd vaccination

Contacts

Public ContactOshio Mika

The Research Foundation for Microbial Diseases of Osaka University

clinicaldevelopment@mail.biken.or.jp+81-6-6877-4812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026