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TAK-816 · 2 trials · 3 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. |
| TAK-816 | EXPERIMENTAL | - |
| ActHIB | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TAK-816 | BIOLOGICAL | TAK-816 intramuscular injection |
| 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. 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 developed by Takeda Pharmaceutical Company Limited for the prevention of Haemophilus influenzae type b disease through immunization. It is designed to be given to healthy infants as a passive immunization approach against this bacterial infection, which can cause serious illness in young children.
TAK-816 is being developed for immunization against Haemophilus influenzae type b, a bacterium that can cause severe infections in infants. The goal is prevention of Hib disease in healthy infants through administration of the monoclonal antibody. It is an investigational product and has not been approved for commercial use.
TAK-816 is developed by Takeda Pharmaceutical Company Limited, a Japanese pharmaceutical company whose shares trade under the ticker TAK. Takeda is the sponsor of the clinical studies evaluating TAK-816 in healthy infants in Japan.
TAK-816 has completed Phase 3 clinical development. Two Phase 3 trials have been conducted in healthy infants in Japan, and both are listed as completed. The drug remains investigational and has not been approved by regulatory authorities for commercial use.
TAK-816 has been studied in two completed Phase 3 trials. NCT02074345 was a Phase III study of intramuscular TAK-816 in healthy infants, enrolling 31 participants in Japan. NCT01379846 was a study of TAK-816 in healthy infants, enrolling 416 participants in Japan, with a minimum age of 3 months.