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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1261-9040 | Other Identifier | WHO | |
| jRCT2071200069 | Registry Identifier | jRCT |
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TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919.
At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-919 or a placebo in their arm. In this study, a placebo will look like the TAK-919 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-919 than placebo. Participants will receive 2 injections of TAK-919 or placebo, 28 days apart.
Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection.
During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have visited their clinic 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.
The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-919 or the placebo.
The drug being tested in this study is called TAK-919. TAK-919 is being tested to prevent infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2). This study will look at the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults, given 28 days apart.
The study will enroll approximately 200 healthy volunteers. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take intramuscular injection in the upper arm twice throughout the study.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is 12 months from the second vaccination. Participants will make multiple visits to the clinic and will be contacted by telephone or a final visit after the last vaccination for a follow-up assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-919 | Biological | TAK-919 intramuscular injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | 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. | Up to Day 7 (6 subsequent days after first vaccination on Day 1) |
| Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | 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. | Up to Day 35 (6 subsequent days after second vaccination on Day 29) |
| Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | 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. | Up to Day 7 (6 subsequent days after first vaccination on Day 1) |
| Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SAE Throughout the Trial | Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this 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 throughout the trial was reported in this outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sumida Hospital | Sumida-ku | Tokyo | Japan | |||
| PS Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35177302 | Derived | Masuda T, Murakami K, Sugiura K, Sakui S, Philip Schuring R, Mori M. A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report. Vaccine. 2022 Mar 18;40(13):2044-2052. doi: 10.1016/j.vaccine.2022.02.030. Epub 2022 Feb 8. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Healthy Japanese participants were enrolled to receive two doses of TAK-919 or saline placebo by intramuscular injection on Day 1 (first vaccination) and Day 29 (second vaccination).
Participants took part in the study at 2 investigative sites in Japan from 07 January 2021 to 22 February 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants. |
| FG001 | TAK-919 0.5 mL | TAK-919 0.5 milliliter (mL), injection, intramuscularly, once on Days 1 and 29 in healthy participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The safety analysis set included all participants who received at least 1 dose of the treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants. |
| BG001 | TAK-919 0.5 mL | TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Up to Day 7 (6 subsequent days after first vaccination on Day 1) |
|
Treatment-emergent adverse events (TEAEs) are AEs that started after the first vaccination on Day 1 up to 365 days after the second vaccination on Day 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2021 | Feb 20, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2021 | Feb 20, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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| Biological |
Placebo intramuscular injection |
|
| Up to Day 35 (6 subsequent days after second vaccination on Day 29) |
| Percentage of Participants With Unsolicited AEs for 28 Days Following First Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. | Up to Day 29 (28 days after first vaccination on Day 1) |
| Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. | Up to Day 57 (28 days after second vaccination on Day 29) |
| Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57 | 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. | Day 1 up to Day 57 |
| Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57 | 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. | Day 1 up to Day 57 |
| Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | 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. | Day 1 up to Day 57 |
| Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 57 | 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. | Day 1 up to Day 57 |
| Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57 | Day 1 up to Day 57 |
| Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57 | 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. | At Day 57 |
| Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 | 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. | At Day 57 |
| Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 | 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. | At Day 57 |
| Day 1 up to Day 394 |
| Percentage of Participants With MAAEs Throughout the Trial | 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 throughout the trial was reported in this outcome measure. | Day 1 up to Day 394 |
| Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial | 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 from the day of vaccination throughout the trial was reported in this outcome measure. | Day 1 up to Day 394 |
| Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial | Day 1 up to Day 394 |
| GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394 | GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein. | At Days 29, 43, 209 and 394 |
| GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394 | 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. | At Days 29, 43, 209 and 394 |
| SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394 | SCR was defined as percentage of participants with a change from below LOD or LLOQ to equal to or above LOD or LLOQ, OR >=4-fold rises from baseline. LLOQ= 1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. 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. | At Days 29, 43, 209 and 394 |
| GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394 | GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ= 159.79 and ULOQ= 11173.11. GMT of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus. | At Days 29, 43, 57, 209, and 394 |
| GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394 | 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 nAb against SARS-CoV-2 was measured by assay specific to wild-type virus. | At Days 29, 43, 57, 209, and 394 |
| SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394 | SCR was defined at percentage of participants with a change from below the LOD or LLOQ to equal to or above LLOQ, OR, >=4-fold rises from baseline. LLOQ= 159.79 and ULOQ= 11173.11. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus. | At Days 29, 43, 57, 209, and 394 |
| Fukuoka |
| Japan |
| Chose Publicly Available Vaccine |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kilogram (kg) |
|
| Height | Mean | Standard Deviation | centimeter (cm) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter (kg/m^2) |
|
| OG001 | TAK-919 0.5 mL | TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants. |
|
|
| Primary | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to Day 35 (6 subsequent days after second vaccination on Day 29) |
|
|
|
| Primary | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Up to Day 7 (6 subsequent days after first vaccination on Day 1) |
|
|
|
| Primary | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to Day 35 (6 subsequent days after second vaccination on Day 29) |
|
|
|
| Primary | Percentage of Participants With Unsolicited AEs for 28 Days Following First Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Up to Day 29 (28 days after first vaccination on Day 1) |
|
|
|
| Primary | Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. | The safety analysis set included all participants who received at least 1 dose of the treatment. Here, "overall number of participants analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | percentage of participants | Up to Day 57 (28 days after second vaccination on Day 29) |
|
|
|
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57 | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 57 |
|
|
|
| Primary | Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57 | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 57 |
|
|
|
| Primary | Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 57 |
|
|
|
| Primary | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 57 | 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. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 57 |
|
|
|
| Primary | Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57 | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 57 |
|
|
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| Primary | Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57 | 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 per-protocol-set (PPS) included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. | Posted | Geometric Mean | 95% Confidence Interval | arbitrary unit per milliliter (AU/mL) | At Day 57 |
|
|
|
| Primary | Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57 | 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. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At Day 57 |
|
|
|
| Primary | Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57 | 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. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | At Day 57 |
|
|
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| Secondary | Percentage of Participants With SAE Throughout the Trial | Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this 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 throughout the trial was reported in this outcome measure. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 394 |
|
|
|
| Secondary | Percentage of Participants With MAAEs Throughout the Trial | 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 throughout the trial was reported in this outcome measure. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 394 |
|
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| Secondary | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial | 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 from the day of vaccination throughout the trial was reported in this outcome measure. | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 394 |
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| Secondary | Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial | The safety analysis set included all participants who received at least 1 dose of the treatment. | Posted | Number | percentage of participants | Day 1 up to Day 394 |
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| Secondary | GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394 | GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints. | Posted | Geometric Mean | 95% Confidence Interval | AU/mL | At Days 29, 43, 209 and 394 |
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| Secondary | GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394 | 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. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At Days 29, 43, 209 and 394 |
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| Secondary | SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394 | SCR was defined as percentage of participants with a change from below LOD or LLOQ to equal to or above LOD or LLOQ, OR >=4-fold rises from baseline. LLOQ= 1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. 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. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints. | Posted | Number | 95% Confidence Interval | percentage of participants | At Days 29, 43, 209 and 394 |
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| Secondary | GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394 | GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ= 159.79 and ULOQ= 11173.11. GMT of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus. | PPS included participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influence the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints. | Posted | Geometric Mean | 95% Confidence Interval | microneutralization titers (MN50) | At Days 29, 43, 57, 209, and 394 |
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| Secondary | GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394 | 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 nAb against SARS-CoV-2 was measured by assay specific to wild-type virus. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints. | Posted | Geometric Mean | 95% Confidence Interval | fold change | At Days 29, 43, 57, 209, and 394 |
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| Secondary | SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394 | SCR was defined at percentage of participants with a change from below the LOD or LLOQ to equal to or above LLOQ, OR, >=4-fold rises from baseline. LLOQ= 159.79 and ULOQ= 11173.11. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus. | The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints. | Posted | Number | 95% Confidence Interval | percentage of participants | At Days 29, 43, 57, 209, and 394 |
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| 0 |
| 50 |
| 0 |
| 50 |
| 21 |
| 50 |
| EG001 | TAK-919 0.5 mL | TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants. | 0 | 150 | 1 | 150 | 144 | 150 |
| Body temperature increased | Investigations | MedDRA 24.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Induration | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Vaccination site erythema | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Vaccination site lymphadenopathy | General disorders | MedDRA 24.0 | Systematic Assessment |
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Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
| Swelling |
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| Induration |
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| Lymphadenopathy (Axillary Swelling or Tenderness at Same Side of Injection Site) |
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| Myalgia |
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| Arthralgia |
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| Nausea/ Vomiting |
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| Chills |
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| Fever |
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| Myalgia |
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