Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-816+ DPT-TAKEDA · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TAK-816 | EXPERIMENTAL | - |
| ActHIB | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-816+ DPT-TAKEDA | BIOLOGICAL | TAK-816 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose. |
| ActHIB+ DPT-TAKEDA | BIOLOGICAL | ActHIB 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose. |
Inclusion Criteria: 1. Male or female infants aged ≥3 and \<7 months (excluding hospitalized infants). 2. Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment. 3. Infants whose parents or legal guardians have agreed to cooperate with the invest...
TAK-816 is an investigational monoclonal antibody being studied for immunization and prevention in healthy infants. It is being evaluated for use against Haemophilus influenzae type b, a bacterial infection, with clinical trials conducted in Japan.
TAK-816 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical trials of this investigational monoclonal antibody in Japan.
TAK-816 is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
TAK-816 has been studied in two completed Phase 3 trials in Japan. NCT01379846 enrolled 416 healthy infants aged 3 months and older, while NCT02074345 enrolled 31 healthy infants aged 2 months and older for prevention of Haemophilus influenzae type b.
TAK-816 is a monoclonal antibody, not a vaccine. It is being studied for immunization and prevention of Haemophilus influenzae type b infection in healthy infants, with trials conducted in Japan.