Phase III study of BK1601 in Japanese pediatric subjects
- Conditions
- Prevention of measles and rubella
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 374
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Seroprotection rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.
- Secondary Outcome Measures
Name Time Method safety<br>Adverse events and adverse reactions<br>efficacy<br>Seroconversion rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.<br>efficacy<br>Geometric mean titer (GMT) of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.