Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-019 · 2 trials · 2 indications
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 20. GMT for each group and GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in participants from the TAK-019-1501 study (NCT04712110) were reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36. Here, ELISA is Enzyme-linked immunosorbent assay.
AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling.
Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache.
Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs.
An SAE was defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, or is an important medical event. Solicited SAEs and unsolicited SAEs were reported.
An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; neuroinflammatory disorders, musculoskeletal and connective tissue disorders, vasculitides, gastrointestinal disorders, hepatic disorders, renal disorders, cardiac disorders, skin disorder, hematologic disorders, metabolic disorders, and other disorders.
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.
Percentage of participants with any AE leading to withdrawal from the trial until Day 29 was reported.
Percentage of participants with SARS-CoV-2 infection until Day 29 of the main part of the trial were reported in this outcome measure.
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, tenderness, erythema/redness, induration, and swelling.
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, tenderness, erythema/redness, induration, and swelling.
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 fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
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 fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Unsolicited AEs were all AEs that were not pre-defined for which the participant was 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 assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 50 were reported in this outcome measure.
AESIs were defined as AEs that were specifically highlighted to the Investigator. Only unsolicited AESI data was planned to be collected and assessed for the assessment of this OM and solicited AESI was out of the scope of assessment. Unsolicited AESIs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited AESIs until Day 50 were reported in this outcome measure.
MAAEs are 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 MAAE was out of the scope of assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 50 were reported in this outcome measure.
Only any 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 assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination until Day 22 were reported in this outcome measure.
Only any unsolicited AE leading to participant's withdrawal from the trial data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal from the trial was out of the scope of assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 50 were reported in this outcome measure.
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below lower limit of quantification (LLOQ) were imputed to a value that was half of the LLOQ. LLOQ was equal to 200. Here, ELISA is Enzyme-linked immunosorbent assay.
GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Baseline was defined as the last measurement taken before the first dose of study intervention.
SCR was defined as percentage of participants with 4-fold or more rises in titer if naive at baseline OR percentage of participants with 2-fold or more rises in titer if seropositive at baseline. Baseline was defined as the last measurement taken before the first dose of study intervention.
SRR was defined as percentage of participants with greater than or equal to (\>=) 95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention.
| Arm | Type | Description |
|---|---|---|
| TAK-019 Main Part | EXPERIMENTAL | TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm |
| TAK-019 Extension Part | EXPERIMENTAL | TAK-019 0 .5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm. The participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will receive a second single booster vaccination of TAK-019 by intramuscular injection. |
| TAK-019 | EXPERIMENTAL | TAK-019 0.5 mL, intramuscular injection in the upper arm |
| Placebo | PLACEBO_COMPARATOR | TAK-019 Matching Placebo, intramuscular injection in the upper arm |
| Name | Type | Description |
|---|---|---|
| TAK-019 | BIOLOGICAL | TAK-019 intramuscular injection |
| Placebo | BIOLOGICAL | Placebo intramuscular injection |
Inclusion Criteria: MAIN PART: 1. Healthy Japanese male and female adult participants aged \>= 20 years of age at the time of signing of informed consent. 2. Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine which is available in Japan 6 to 12 months prior ...
TAK-019 is an investigational monoclonal antibody being studied for the prevention of infection disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Coronavirus Disease (COVID-19). It is being developed by Takeda Pharmaceutical Company Limited and is currently in Phase 3 clinical development.
TAK-019 is being developed by Takeda Pharmaceutical Company Limited, which is publicly traded under the ticker TAK. The company is conducting clinical trials for this investigational monoclonal antibody in Japan.
TAK-019 is in Phase 3 clinical development. It has completed a Phase 1 study and a Phase 3 study, both in healthy Japanese adults. The drug is investigational and has not been approved by regulatory authorities.
TAK-019 has been studied in two completed clinical trials: NCT04712110, a Phase 1 study in healthy Japanese adults for prevention of SARS-CoV-2 infection, and NCT05299359, a Phase 3 heterologous booster vaccination study in healthy Japanese adults for COVID-19. Both trials were conducted in Japan.
TAK-019 is a monoclonal antibody, which means it is designed to target a specific protein. However, the specific molecular target of TAK-019 has not been disclosed in the available information.