Phase III study of BK1601 in Japanese pediatric subjects

Phase 3

Completed

• Conditions: Prevention of measles and rubella

• Registration Number: JPRN-jRCT2080225149
• Lead Sponsor: The Research Foundation for Microbial Diseases of Osaka University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-01
• Study Completion: 2020-12-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Japanese healthy and pediatric subjects aged from 5 years to 7 years old before elementary school.
2. Subjects who had been vaccinated against measles and rubella at the age of one.
3. Subjects who had not been vaccinated against measles and rubella since the age of one.
4. Subject's guardians (Parents) are able and willing to comply with study procedures and provide the signed informed consent.

Exclusion Criteria

1. Subjects who had history of measles or rubella.
2. Subjects who had are known exposure to measles or rubella during the period starting from 28 days or less prior to study administration.
3. Subjects who had history of anaphylaxis to food or drug.
4. Subjects who had histories of cardiovascular disease, blood system, liver, kidney, digestive system, metabolism, neuropsychiatric disease.
5. Subjects who have a current history of apparent immunologic disorder and/or under immunosuppressive therapy.
6. 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.
7. Subjects who have received other investigational products from 4 month (Day-112) or less prior to study administration.
8. 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.
9. 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>Geometric mean titer (GMT) and GMT increase of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.<br>efficacy<br>Seroprotection rate of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.<br>safety<br>Adverse events and adverse reactions

Secondary Outcome Measures

Name	Time	Method
efficacy<br>Geometric mean titer (GMT) and GMT increase of measles virus neutralizing antibodies and rubella virus HI antibodies after study administration.<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) and GMT increase of measles virus neutralizing antibodies and rubella virus HI antibodies compared by MR vaccine had been vaccinatedat at the age of one.<br>efficacy<br>Seroconversion rate of measles virus neutralizing antibodies and rubella virus HI antibodies compared by MR vaccine had been vaccinatedat at the age of one.