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Confirmatory Study of BK1310 in Healthy Infants | Clinical Trials | Clareo Health

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COMPLETEDPhase 3NCT03891758

Confirmatory Study of BK1310 in Healthy Infants

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared no...

Lead sponsor: Tanabe Pharma Corporation•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Tanabe Pharma Corporation

Collaborators

The Research Foundation for Microbial Diseases of Osaka University

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months)
•Written informed consent is obtained from a legal guardian (parent)

Exclusion Criteria

•Possibility of anaphylaxis due to food or pharmaceuticals
•With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
•With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
•Participated in other studies within 12 weeks before obtaining consent
•Additional screening criteria check may apply for qualification.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 6, 2026Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment267

Start dateApr 2019

Last updatedJan 6, 2026

Condition

Tetanus Diphtheria Pertussis Poliomyelitis Bacterial Meningitis

Locations shown

Investigational Site

Fukuoka, Fukuoka

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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