Prevention of measles and rubella
Conditions
Sponsors
The Research Foundation for Microbial Diseases of Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Japanese healthy and pediatric subjects aged from 12 months to 24 months old at time of on administration. -Subjects who had not been vaccinated against measles and rubella. -Subject's guardians (Parents) are able and willing to comply with study procedures and provide the signed informed consent.
Exclusion criteria
Exclusion criteria: -Subjects who had history of measles or rubella. -Subjects who had are known exposure to measles or rubella during the period starting from 28 days or less prior to study administration. -Subjects who had history of anaphylaxis to food or drug. -Subjects who had histories of cardiovascular disease, blood system, liver, kidney, digestive system, metabolism, neuropsychiatric disease. -Subjects who have a current history of apparent immunologic disorder and/or under immunosuppressive therapy. -Subjects who received blood transfusion and/or gamma globulin preparation from 3 months (Day-84) or less, and/or received high-dose therapy (200 mg /kg or more) of gamma globulin preparation from 6 months (Day-168) or less prior to study administration. -Subjects who have received other investigational products from 4 month (Day-112) or less prior to study administration. -Subjects who received a live vaccine from 27 days (Day-27) or less prior, and/or inactivated vaccine from 6 days (Day-6) or less prior and/or toxoid from 6 days (Day-6) or less prior to study administration. -Those who are medically decided to be unsuitable for this study by the investigator or the sub investigator due to factors other than above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Seroprotection rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety Adverse events and adverse reactions efficacy Seroconversion rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration. efficacy Geometric mean titer (GMT) of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration. | — |
Countries
Japan
Outcome results
None listed