JPRN-jRCT2080222404UnknownPhase 3
A phase III, multicenter, open-label study to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy infants
TAKEDA PHARMACEUTICAL COMPANY LTD.0 sites30 target enrollmentStarted: February 21, 2014Last updated:
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- ot applicable to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1.Healthy Japanese infants
- •2.Male or female infants aged 2-6 months (>=2 and <7 months) at the time of the first dose of investigational product (excluding hospitalized infants)
- •3.Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
Exclusion Criteria
- •1. Any serious acute illness.
- •2. Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
- •3. History of possible Haemophilus influenzae type b (Hib) infection.
- •4. Previously diagnosed immunodeficiency.
- •5. Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid)
- •6. A history of convulsions.
- •7. Previous administration of another Hib vaccine.
- •8. Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
- •9. Prior participation in any clinical study or post-marketing clinical study
- •10. Previously receipt of blood transfusions, gamma globulin preparations (except monoclonal vaccines as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period
- •11. Presence of thrombocytopenia or coagulopathy
Investigators
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