Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05299359 | A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19) | PHASE3 | COMPLETED | 150 | — | — | Apr 15, 2022 | Oct 18, 2023 | Oct 21, 2024 | 2 | Japan |
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.
| 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. |
| Name | Type | Description |
|---|---|---|
| TAK-019 | BIOLOGICAL | TAK-019 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 ...