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Confirmatory study of BK-4SP in healthy infants.

Confirmatory study of BK-4SP in healthy infants.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221090
Enrollment
326
Registered
2010-05-25
Start date
2010-05-25
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection.

Interventions

investigational material(s) Generic name etc : BK-4SP INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : subcutaneous

Sponsors

The Research Foundation for Microbial Diseases of Osaka University, Tanabe Pharma Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age: greater than 3months old ,less than 74 months old

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Immunogenicity

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026