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A phase 2, Dose-finding Study of TAK-361S in Healthy Pediatric Subjects

A Randomized, Double-Blind, Multicenter, Parallel-group, Phase 2 Study to Evaluate the Efficacy and Safety of Subcutaneous TAK-361S, 3 dosage levels in the Prevention of Diphtheria, Pertussis, Tetanus, and Poliomyelitis in Healthy Pediatric Subjects.

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221634
Enrollment
Unknown
Registered
2011-11-01
Start date
2011-11-01
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

Prevention of diphtheria, pertussis, tetanus, and poliomyelitis

Interventions

investigational material(s) Generic name etc : TAK-361S INN of investigational material : Therapeutic category code : 636 Mixed biological preparations Dosage and Administration for Investigational m

Sponsors

TAKEDA PHARMACEUTICAL COMPANY LTD.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese pediatric subjects 2. Aged between 3 and 67 months at the commencement of vaccination with the study drug

Exclusion criteria

Exclusion criteria: 1. History of poliomyelitis, diphtheria, pertussis, or tetanus 2. Any underlying cardiovascular, renal, hepatic, or hematological disease, and/or developmental disorder 3. History of any significant febrile reaction within 2 days following previous any other vaccination or any symptom indicative of possible allergy such as generalized rash following previous any other vaccination 4. History of convulsions 5. Previous diagnosed immunodeficiency 6. Previous administrasion of any other vaccine containing any of the components of polio, diphtheria, pertussis, or tetanus (including vaccines containing any of the components as a carrier protein)

Outcome results

None listed

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