A observer-blind, active-controlled, multi-center, phase III, comparative study of the efficacy and safety of BK1601 and MR vaccine in Japanese pediatric subjects aged from 12 months to 24 months old.
Phase III study of BK1601 in Japanese pediatric subjects
Dec. 18, 2020
No
version:
date:
Biken
3-1, Yamada oka, Suita, Osaka, Japan
+81-6-6877-4812
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Biken
3-1, Yamada oka, Suita, Osaka, Japan
+81-6-6877-4812
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completed
Aug. 05, 2019
374
Interventional
Multicenter, active control, randomized, parallel group comparison, observer-blind
prevention purpose
3
-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.
12month old over
24month old under
Both
Prevention of measles and rubella
investigational material(s)
Generic name etc : BK1601
INN of investigational material : -
Therapeutic category code : 636 Mixed biological preparations
Dosage and Administration for Investigational material : Product is dissolved with 0.7 mL of the supplied solvent, and single subcutaneous injection is given with 0.5 mL of the solution in the brachial region.
control material(s)
Generic name etc : Freeze-dried Live Attenuated Measles, Rubella Combined Vaccine
INN of investigational material : -
Therapeutic category code : 636 Mixed biological preparations
Dosage and Administration for Investigational material : Product is dissolved with 0.7 mL of the supplied solvent, and single subcutaneous injection is given with 0.5 mL of the solution in the brachial region.
efficacy
Seroprotection rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.
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.
The Research Foundation for Microbial Diseases of Osaka University
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Institutional Review Board of Medical Corporation Ohryokukai, Nihonbashi Sakura Clinic
Inamura Bldg. 5F, 1-9-2, Nihonbashi Kayaba-cho, Chuo-ku, Tokyo, JAPAN
