Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-816 · 1 trial · 2 indications
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions.
Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.
Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).
Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).
| Arm | Type | Description |
|---|---|---|
| TAK-816 0.5 mL | EXPERIMENTAL | Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization. |
| Name | Type | Description |
|---|---|---|
| TAK-816 | BIOLOGICAL | TAK-816 intramuscular injection |
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...
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.