Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-919 · 1 trial · 1 indication
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this outcome measure (OM) and solicited SAE was out of the scope of the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 57 was reported in this outcome measure.
MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 57 was reported in this outcome measure.
Only unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination was reported in this outcome measure.
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 57 was reported in this outcome measure.
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below lower limit of quantification (LLOQ) were imputed to a value that is half of the LLOQ. Titer values measured as above upper limit of quantification (ULOQ) were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 spike (S) protein.
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
SCR was defined as percentage of participants with a change from below limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ, OR, greater than or equal to (\>=) 4-fold rises from baseline. LLOQ= 1, ULOQ= 2052. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
| Arm | Type | Description |
|---|---|---|
| TAK-919 | EXPERIMENTAL | TAK-919 0.5 mL, intramuscular injection in the upper arm |
| Placebo | PLACEBO_COMPARATOR | TAK-919 Matching Placebo, intramuscular injection in the upper arm |
| Name | Type | Description |
|---|---|---|
| TAK-919 | BIOLOGICAL | TAK-919 intramuscular injection |
| Placebo | BIOLOGICAL | Placebo intramuscular injection |
Inclusion Criteria: 1. Healthy Japanese male and female participants. 2. Participants who understand and are willing to comply with trial procedures and are available for the duration of follow up. Exclusion Criteria: 1. Participants who received any other SARS-CoV-2 or other experimental novel c...
TAK-919 is an investigational monoclonal antibody being developed for the prevention or treatment of Coronavirus Disease (COVID-19). It is currently in Phase 1 clinical development, meaning it has not yet been approved for use and is still being evaluated in clinical trials.
TAK-919 is a monoclonal antibody, a type of biologic drug designed to bind to a specific target. The exact molecular target of TAK-919 has not been disclosed in available information, so its precise mechanism of action is not publicly detailed.
TAK-919 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda's stock is traded under the ticker symbol TAK on the New York Stock Exchange.
TAK-919 is in Phase 1 clinical development. A Phase 1 trial of TAK-919 has been completed, and the drug remains investigational. It is not approved by regulatory authorities and is still undergoing clinical evaluation for COVID-19.
TAK-919 has one completed clinical trial, identified as NCT04677660. This was a Phase 1, randomized, double-blind, placebo-controlled study in healthy Japanese adults aged 20 years and older, with 200 participants enrolled. The trial was conducted in Japan.
TAK-919 is a distinct investigational monoclonal antibody developed by Takeda. It is not known to be the same as other marketed or investigational COVID-19 antibodies, as no alternative names have been associated with it in available information.