Phase 2 study of BK1901 as a Booster in Japanese children

JRCT ID: jRCT2031200412

Registered date:11/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of pertussis, diphtheria, tetanus, and acute poliomyelitis
• Date of first enrollment: 01/03/2021
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Subcutaneous injection of DPT-IPV(0.5 mL) , DPT(0.5 mL) and IPV(0.5mL).

Outcome(s)

Primary Outcome

1. Booster response rates against diphtheria toxin,tetanus toxin, pertussis(PT,FHA), and polio virus(types 1, 2 or 3) .
2. Adverse events and adverse reactions.

Secondary Outcome

1. Antibody prevalence rate, geometric mean titer (GMT) and GMT increase against diphtheria toxin, tetanus toxin and pertussis(PT,FHA).
2. Antibody prevalence rate, geometric mean titer (GMT) and GMT increase against polio virus(types 1, 2 or 3).

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 7age old
• Gender: Both

Include criteria

1. Japanese healthy children aged 5 to less than 7 years old on the day of injection.
2. Subjects who has written informed consent from legal guardian and has obtained an assent from subject.
3. Subjects are able to comply with the study procedures.
4. Subjects who had been vaccinated 3 or 4 times DPT-IPV with the same products at <30 months old and have not been vaccinated DPT-IPV since then.

Exclude criteria

1. Subjects who had history of diphtheria, pertussis, tetanus or acute poliomyelitis.
2. Subjects who had history of diphteria, pertussis, tetanus or polio vaccination except DPT-IPV.
3. Subjects who had history of COVID-19.
4. Subjects who had history of anaphylaxis to the components of the study drug.
5. Subjects who had histories of cardiovascular disease, blood system, liver, kidney, digestive system, metabolism, neuropsychiatric disease.
6. Subjects who have a current history of apparent immunologic disorder and/or under immunosuppressive therapy.
7. Subjects who received blood transfusion and/or gamma globulin preparation from Day-90 or less, and/or received high-dose therapy (200mg/kg or more) of gamma globulin preparation from Day-180 or less prior to study administration.
8. Subjects who have received other investigational products from Day-120 or less prior to study administration.
9. Subjects who have been considered to be not eligible by the principal investigators (sub-investigators) for the enrollment.

Related Information

• Primary Sponsor: Fuji Hideyuki