drugset / Trial / NCT01379846
Study of TAK-816 in Healthy Infants
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.
Timeline
- Start
- 2011-06
- Primary completion
- 2013-02
- Completion
- 2013-02
Publications
- Akeda Y, Koizumi Y, Takanami Y, Sumino S, Hattori Y, Sugizaki K, Mitsuya N, Oishi K. Comparison of serum bactericidal and antibody titers induced by two Haemophilus influenzae type b conjugate vaccines: A phase III randomized double-blind study. Vaccine. 2018 Mar 14;36(12):1528-1532. doi: 10.1016/j.vaccine.2018.02.011. Epub 2018 Feb 17.
- Togashi T, Mitsuya N, Kogawara O, Sumino S, Takanami Y, Sugizaki K. Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III, randomized, observer-blind, multicenter, parallel-group study. Vaccine. 2016 Aug 31;34(38):4635-4641. doi: 10.1016/j.vaccine.2016.05.050. Epub 2016 Jul 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ActHIB | Vaccine | 10 ug | Subcutaneous |
| Subject | DPT-TAKEDA | Vaccine | 0.5 ml | Subcutaneous |
| Subject | TAK-816 | Vaccine | 10 ug | Subcutaneous |
Indications
No indication recorded.