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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1262-6244 | Other Identifier | WHO | |
| jRCT2071200084 | Registry Identifier | jRCT |
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TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019.
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-019 or a placebo in their arm. In this study, a placebo will look like the TAK-019 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-019 than placebo. Participants will receive 2 injections of TAK-019 or placebo, 21 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 attended a clinic visit 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-019 or the placebo.
The drug being tested in this study is called TAK-019. TAK-019 is being tested to prevent infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2). This study will look at the evaluate the safety and immunogenicity of 2 doses of TAK-019 by intramuscular (IM) injection 21 days apart in healthy Japanese male and female adults.
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 (totally 387 days). 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-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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-019 | Biological | TAK-019 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, tenderness, erythema/redness, induration, and swelling. | 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, tenderness, erythema/redness, induration, and swelling. | Up to Day 28 (6 subsequent days after second vaccination on Day 22) |
| 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 fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache. | 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 fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache. | Up to Day 28 (6 subsequent days after second vaccination on Day 22) |
| 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 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 throughout the trial were 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 | |||
| Nishi Kumamoto Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35501178 | Derived | Masuda T, Murakami K, Sugiura K, Sakui S, Schuring RP, Mori M. Safety and immunogenicity of NVX-CoV2373 (TAK-019) vaccine in healthy Japanese adults: Interim report of a phase I/II randomized controlled trial. Vaccine. 2022 May 26;40(24):3380-3388. doi: 10.1016/j.vaccine.2022.04.035. Epub 2022 Apr 29. |
| 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-019 or placebo by intramuscular injection on Day 1 (first vaccination) and Day 22 (second vaccination).
Participants took part in the study at 2 investigative sites in Japan from 12 February 2021 to 28 March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants. |
| FG001 | TAK-019 0.5 mL | TAK-019 0.5 milliliter (mL), injection, intramuscularly, once on Days 1 and 22 in the 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-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants. |
| BG001 | TAK-019 0.5 mL | TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the 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, tenderness, erythema/redness, induration, and swelling. | 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 22 (Day 387)
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-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | 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 | Mar 27, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2021 | Mar 27, 2023 | SAP_001.pdf |
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| Biological |
Placebo intramuscular injection |
|
| Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. | Up to Day 21 (20 days after first vaccination on Day 1) |
| Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. | Up to Day 49 (27 days after second vaccination on Day 22) |
| Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50 | 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. | Day 1 up to Day 50 |
| Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50 | 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. | Day 1 up to Day 50 |
| Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50 | 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. | Day 1 up to Day 50 |
| Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | 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. | Day 1 up to Day 22 |
| Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50 | 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. | Day 1 up to Day 50 |
| Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50 | Day 1 up to Day 50 |
| Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36 | 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. | At Day 36 |
| Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 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. | At Day 36 |
| Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 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. | At Day 36 |
| Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 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. | At Day 36 |
| Day 1 up to Day 387 |
| Percentage of Participants With AESI Throughout the Trial | 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 AESI 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 throughout the trial were reported in this outcome measure. | Day 1 up to Day 387 |
| Percentage of Participants With MAAEs Throughout the Trial | 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 throughout the trial were reported in this outcome measure. | Day 1 up to Day 387 |
| Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial | 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 withdrawal from the trial from the day of vaccination throughout the trial were reported in this outcome measure. | Day 1 up to Day 387 |
| Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial | Day 1 up to Day 387 |
| GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 200. | At Days 22, 50, 202, and 387 |
| GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | 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. | At Days 22, 50, 202, and 387 |
| SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | 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. | At Days 22, 50, 202, and 387 |
| SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. | At Days 22, 50, 202, and 387 |
| GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (>=) 50% of the replicate wells were protected from infection (MN50). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 20. | At Days 22, 36, 50, 202 and 387 |
| GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). 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. | At Days 22, 36, 50, 202 and 387 |
| SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). 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. | At Days 22, 36, 50, 202 and 387 |
| SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. | At Days 22, 36, 50, 202 and 387 |
| Kumamoto |
| Japan |
| Chose Publicly Available SARS-CoV-2 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-019 0.5 mL |
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the 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, tenderness, erythema/redness, induration, and swelling. | 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 received second vaccination. | Posted | Number | percentage of participants | Up to Day 28 (6 subsequent days after second vaccination on Day 22) |
|
|
|
| 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 fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache. | 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 fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache. | 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 received second vaccination. | Posted | Number | percentage of participants | Up to Day 28 (6 subsequent days after second vaccination on Day 22) |
|
|
|
| Primary | Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant was 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 21 (20 days after first vaccination on Day 1) |
|
|
|
| Primary | Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination | Unsolicited AEs were all AEs that were not pre-defined for which the participant was 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 received second vaccination. | Posted | Number | percentage of participants | Up to Day 49 (27 days after second vaccination on Day 22) |
|
|
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50 | 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. | 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 50 |
|
|
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| Primary | Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50 | 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. | 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 50 |
|
|
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| Primary | Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50 | 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. | 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 50 |
|
|
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| Primary | Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | 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. | 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 22 |
|
|
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| Primary | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50 | 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. | 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 50 |
|
|
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| Primary | Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50 | 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 50 |
|
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| Primary | Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36 | 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. | The per-protocol set (PPS) included all randomized participants who received at least one dose of treatment and had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. | Posted | Geometric Mean | 95% Confidence Interval | ELISA units per mL (EU/mL) | At Day 36 |
|
|
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| Primary | Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 36 |
|
|
|
| Primary | Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 36 |
|
|
|
| Primary | Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 36 |
|
|
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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 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 throughout the trial were 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 387 |
|
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| Secondary | Percentage of Participants With AESI Throughout the Trial | 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 AESI 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 throughout the trial were 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 387 |
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| Secondary | Percentage of Participants With MAAEs Throughout the Trial | 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 throughout the trial were 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 387 |
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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 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 withdrawal from the trial from the day of vaccination throughout the trial were 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 387 |
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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 387 |
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| Secondary | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 200. | The PPS included all randomized participants who received at least one dose of treatment and 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 | EU/mL | At Days 22, 50, 202, and 387 |
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| Secondary | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 22, 50, 202, and 387 |
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| Secondary | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 22, 50, 202, and 387 |
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| Secondary | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. | The PPS included all randomized participants who received at least one dose of treatment and 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 22, 50, 202, and 387 |
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| Secondary | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which greater than or equal to (>=) 50% of the replicate wells were protected from infection (MN50). GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. GMT of serum IgG antibody levels to the SARS-CoV-2 rS protein was measured where LLOQ was equal to 20. | The PPS included all randomized participants who received at least one dose of treatment and 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 | 1 per dilution | At Days 22, 36, 50, 202 and 387 |
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| Secondary | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 22, 36, 50, 202 and 387 |
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| Secondary | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). 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. | The PPS included all randomized participants who received at least one dose of treatment and 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 22, 36, 50, 202 and 387 |
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| Secondary | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | The neutralization titer was expressed as the reciprocal of the highest dilution at which >=50% of the replicate wells were protected from infection (MN50). SRR was defined as percentage of participants with >=95 percentile in titer at Baseline for all participants. Baseline was defined as the last measurement taken before the first dose of study intervention. | The PPS included all randomized participants who received at least one dose of treatment and 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 22, 36, 50, 202 and 387 |
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| 0 |
| 50 |
| 1 |
| 50 |
| 11 |
| 50 |
| EG001 | TAK-019 | TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants. | 0 | 150 | 0 | 150 | 124 | 150 |
| Body temperature increased | Investigations | 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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| Malaise | 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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| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 24.0 | Systematic Assessment |
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| Tenderness | 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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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.
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