Prevention of Infection Disease Caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
Conditions
Brief summary
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.
Detailed description
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): * TAK-019 0.5 mL * Placebo- this is an injection that looks like the study drug but has no active ingredient 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.
Interventions
BIOLOGICALTAK-019
TAK-019 intramuscular injection
BIOLOGICALPlacebo
Placebo intramuscular injection
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Japanese male and female adult participants aged \>= 20 years of age at the time of signing of informed consent. 2. Participants who understand and are willing to comply with trial procedures and are available for the duration of follow-up.
Exclusion criteria
1. Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial. 2. Participants who have close contact of anyone known to have COVID-19 within 30 days prior to the trial vaccination. 3. Participants who were tested positive for SARS-CoV-2 prior to the trial or before the trial vaccination. 4. Participants who are on current treatment with other investigational agents for prophylaxis of COVID-19. 5. Participants who have traveled outside of Japan in the 30 days prior to the trial participation. 6. Participants with a clinically significant active infection (as assessed by the Investigator) or oral temperature \>= 38 degree Celsius within 3 days of the intended date of vaccination. 7. Participants with known hypersensitivity or allergy to any of the investigational vaccine components. 8. Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial. 9. Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease. 10. Abnormalities of splenic or thymic function. 11. Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 12. Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease). 13. Participants with body mass index (BMI) greater than or equal to 30 kg/m\^2 (BMI= weight in kg/ height in meters\^2). 14. Participants participating in any clinical trial with another investigational product within 30 days prior to the trial vaccination or intend to participate in another clinical trial at any time during the conduct of this trial. 15. Participants who received or plan to receive any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration. 16. Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic or renal abnormality evaluated by physical examination. 17. Participants involved in the trial conduct or their first degree relatives. 18. Participants who have history or infection of hepatitis B, hepatitis C, and human immunodeficiency virus infection. 19. Female participants who are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | At 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. |
| Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Up to Day 28 (6 subsequent days after second vaccination on Day 22) | 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. |
| Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Up to Day 7 (6 subsequent days after first vaccination on Day 1) | 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. |
| Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Up to Day 28 (6 subsequent days after second vaccination on Day 22) | 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. |
| Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination | Up to Day 21 (20 days after first vaccination on Day 1) | Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. |
| Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50 | Day 1 up to Day 50 | — |
| Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50 | Day 1 up to 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. |
| Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50 | Day 1 up to 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. |
| Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50 | Day 1 up to 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. |
| Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | Day 1 up to Day 22 | 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. |
| Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50 | Day 1 up to 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. |
| Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36 | At 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. |
| Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | At 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. |
| Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | At 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. |
| Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination | Up to Day 49 (27 days after second vaccination on Day 22) | Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary. |
| Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Up to Day 7 (6 subsequent days after first vaccination on Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With AESI Throughout the Trial | Day 1 up to Day 387 | 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. |
| Percentage of Participants With MAAEs Throughout the Trial | Day 1 up to Day 387 | 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. |
| Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial | Day 1 up to Day 387 | 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. |
| 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 | At 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. |
| GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | At 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. |
| SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | At 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. |
| SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | At 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. |
| GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | At Days 22, 36, 50, 202 and 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. |
| GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | At 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. |
| SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | At 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. |
| SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | At 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. |
| Percentage of Participants With SAE Throughout the Trial | Day 1 up to Day 387 | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 2 investigative sites in Japan from 12 February 2021 to 28 March 2022.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| Placebo TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants. | 50 |
| TAK-019 0.5 mL TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants. | 150 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Chose Publicly Available SARS-CoV-2 Vaccine | 46 | 14 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Placebo | TAK-019 0.5 mL | Total |
|---|---|---|---|
| Age, Continuous | 50.8 years STANDARD_DEVIATION 16.42 | 52.6 years STANDARD_DEVIATION 15.8 | 52.2 years STANDARD_DEVIATION 15.93 |
| Body Mass Index (BMI) | 22.80 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.865 | 23.29 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.85 | 23.17 kilogram per square meter (kg/m^2) STANDARD_DEVIATION 2.854 |
| Height | 164.00 centimeter (cm) STANDARD_DEVIATION 9.157 | 164.10 centimeter (cm) STANDARD_DEVIATION 8.596 | 164.08 centimeter (cm) STANDARD_DEVIATION 8.716 |
| Race/Ethnicity, Customized Japanese | 50 Participants | 150 Participants | 200 Participants |
| Region of Enrollment Japan | 50 Participants | 150 Participants | 200 Participants |
| Sex: Female, Male Female | 21 Participants | 65 Participants | 86 Participants |
| Sex: Female, Male Male | 29 Participants | 85 Participants | 114 Participants |
| Weight | 61.73 kilogram (kg) STANDARD_DEVIATION 11.806 | 62.94 kilogram (kg) STANDARD_DEVIATION 10.485 | 62.64 kilogram (kg) STANDARD_DEVIATION 10.813 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 150 |
| other Total, other adverse events | 11 / 50 | 124 / 150 |
| serious Total, serious adverse events | 1 / 50 | 0 / 150 |
Outcome results
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.
Time frame: At Day 36
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 1.0 fold change |
| TAK-019 0.5 mL | Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 258.8 fold change |
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.
Time frame: At Day 36
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Placebo | Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36 | 132.3 ELISA units per mL (EU/mL) |
| TAK-019 0.5 mL | Geometric Mean Titers (GMT) of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 36 | 31036.8 ELISA units per mL (EU/mL) |
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.
Time frame: Day 1 up to Day 50
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50 | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50 | 0.0 percentage of participants |
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.
Time frame: Day 1 up to Day 22
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | 2.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Any AE Leading to Discontinuation of Vaccination | 0.0 percentage of participants |
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.
Time frame: Day 1 up to Day 50
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50 | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50 | 0.0 percentage of participants |
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.
Time frame: Day 1 up to Day 50
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50 | 4.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50 | 2.7 percentage of participants |
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.
Time frame: Day 1 up to Day 50
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50 | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50 | 0.0 percentage of participants |
Primary
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50
Time frame: Day 1 up to Day 50
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50 | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50 | 0.0 percentage of participants |
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.
Time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Tenderness | 4.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Induration | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Erythema/redness | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Swelling | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Injection site pain | 4.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Swelling | 2.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Injection site pain | 29.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Tenderness | 43.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Erythema/redness | 2.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination | Induration | 3.3 percentage of 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.
Time frame: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Tenderness | 4.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Induration | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Erythema/redness | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Swelling | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Injection site pain | 2.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Swelling | 17.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Injection site pain | 50.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Tenderness | 62.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Erythema/redness | 15.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination | Induration | 11.3 percentage of participants |
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.
Time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Malaise | 4.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Arthralgia | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Fatigue | 6.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Nausea/vomiting | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Myalgia | 4.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Headache | 2.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Fever | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Headache | 10.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Fever | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Fatigue | 8.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Malaise | 10.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Myalgia | 17.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Arthralgia | 4.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination | Nausea/vomiting | 0.7 percentage of participants |
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.
Time frame: Up to Day 28 (6 subsequent days after second vaccination on Day 22)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Malaise | 6.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Arthralgia | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Fatigue | 8.2 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Nausea/vomiting | 0.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Myalgia | 4.1 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Headache | 2.0 percentage of participants |
| Placebo | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Fever | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Headache | 21.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Fever | 6.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Fatigue | 20.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Malaise | 29.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Myalgia | 32.7 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Arthralgia | 13.3 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination | Nausea/vomiting | 5.3 percentage of participants |
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.
Time frame: Up to Day 21 (20 days after first vaccination on Day 1)
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination | 8.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination | 10.0 percentage of participants |
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.
Time frame: Up to Day 49 (27 days after second vaccination on Day 22)
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination | 12.2 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination | 29.3 percentage of participants |
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.
Time frame: At Day 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 0.0 percentage of participants |
| TAK-019 0.5 mL | Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 100.0 percentage of participants |
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.
Time frame: At Day 36
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 8.2 percentage of participants |
| TAK-019 0.5 mL | Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36 | 100.0 percentage of participants |
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.
Time frame: At Days 22, 50, 202, and 387
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 1.1 fold change |
| Placebo | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 1.0 fold change |
| Placebo | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 8.5 fold change |
| Placebo | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 2.4 fold change |
| TAK-019 0.5 mL | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 27.9 fold change |
| TAK-019 0.5 mL | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 11.6 fold change |
| TAK-019 0.5 mL | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 36.4 fold change |
| TAK-019 0.5 mL | GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 199.1 fold change |
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.
Time frame: At Days 22, 36, 50, 202 and 387
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 36 | 1.0 fold change |
| Placebo | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 202 | 5.0 fold change |
| Placebo | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 50 | 1.0 fold change |
| Placebo | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 387 | 1.4 fold change |
| Placebo | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 22 | 1.0 fold change |
| TAK-019 0.5 mL | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 387 | 6.5 fold change |
| TAK-019 0.5 mL | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 22 | 5.0 fold change |
| TAK-019 0.5 mL | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 36 | 88.0 fold change |
| TAK-019 0.5 mL | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 50 | 50.7 fold change |
| TAK-019 0.5 mL | GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 202 | 6.5 fold change |
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.
Time frame: At Days 22, 50, 202, and 387
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 144.9 EU/mL |
| Placebo | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 134.7 EU/mL |
| Placebo | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 851.0 EU/mL |
| Placebo | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 236.7 EU/mL |
| TAK-019 0.5 mL | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 3461.2 EU/mL |
| TAK-019 0.5 mL | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 1390.0 EU/mL |
| TAK-019 0.5 mL | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 4390.1 EU/mL |
| TAK-019 0.5 mL | GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 23910.8 EU/mL |
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.
Time frame: At Days 22, 36, 50, 202 and 387
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 36 | 10.4 1 per dilution |
| Placebo | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 202 | 50.4 1 per dilution |
| Placebo | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 50 | 10.4 1 per dilution |
| Placebo | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 387 | 14.1 1 per dilution |
| Placebo | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 22 | 10.4 1 per dilution |
| TAK-019 0.5 mL | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 387 | 65.7 1 per dilution |
| TAK-019 0.5 mL | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 22 | 50.2 1 per dilution |
| TAK-019 0.5 mL | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 36 | 884.4 1 per dilution |
| TAK-019 0.5 mL | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 50 | 509.5 1 per dilution |
| TAK-019 0.5 mL | GMT of Serum Neutralizing Antibody (nAb) Titers to Wild Type Virus on Days 22, 36, 50, 202 and Day 387 | Day 202 | 65.5 1 per dilution |
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.
Time frame: Day 1 up to Day 387
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With AESI Throughout the Trial | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With AESI Throughout the Trial | 0.0 percentage of participants |
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.
Time frame: Day 1 up to Day 387
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial | 0.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial | 0.0 percentage of participants |
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.
Time frame: Day 1 up to Day 387
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With MAAEs Throughout the Trial | 6.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With MAAEs Throughout the Trial | 10.7 percentage of participants |
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.
Time frame: Day 1 up to Day 387
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With SAE Throughout the Trial | 2.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With SAE Throughout the Trial | 0.0 percentage of participants |
Secondary
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
Time frame: Day 1 up to Day 387
Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial | 2.0 percentage of participants |
| TAK-019 0.5 mL | Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial | 2.7 percentage of participants |
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.
Time frame: At Days 22, 50, 202, and 387
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 6.1 percentage of participants |
| Placebo | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 2.0 percentage of participants |
| Placebo | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 33.3 percentage of participants |
| Placebo | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 25.0 percentage of participants |
| TAK-019 0.5 mL | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 96.9 percentage of participants |
| TAK-019 0.5 mL | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 82.7 percentage of participants |
| TAK-019 0.5 mL | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 97.9 percentage of participants |
| TAK-019 0.5 mL | SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 100.0 percentage of participants |
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.
Time frame: At Days 22, 36, 50, 202 and 387
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 36 | 0.0 percentage of participants |
| Placebo | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 202 | 33.3 percentage of participants |
| Placebo | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 50 | 0.0 percentage of participants |
| Placebo | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 387 | 25.0 percentage of participants |
| Placebo | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 22 | 0.0 percentage of participants |
| TAK-019 0.5 mL | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 387 | 70.9 percentage of participants |
| TAK-019 0.5 mL | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 22 | 67.3 percentage of participants |
| TAK-019 0.5 mL | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 36 | 99.3 percentage of participants |
| TAK-019 0.5 mL | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 50 | 98.0 percentage of participants |
| TAK-019 0.5 mL | SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 202 | 76.0 percentage of participants |
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.
Time frame: At Days 22, 50, 202, and 387
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 10.2 percentage of participants |
| Placebo | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 12.2 percentage of participants |
| Placebo | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 33.3 percentage of participants |
| Placebo | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 25.0 percentage of participants |
| TAK-019 0.5 mL | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 387 | 96.9 percentage of participants |
| TAK-019 0.5 mL | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 22 | 84.0 percentage of participants |
| TAK-019 0.5 mL | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 202 | 97.9 percentage of participants |
| TAK-019 0.5 mL | SRR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Days 22, 50, 202, and 387 | Day 50 | 100.0 percentage of participants |
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.
Time frame: At Days 22, 36, 50, 202 and 387
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 36 | 100.0 percentage of participants |
| Placebo | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 202 | 100.0 percentage of participants |
| Placebo | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 50 | 100.0 percentage of participants |
| Placebo | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 387 | 100.0 percentage of participants |
| Placebo | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 22 | 100.0 percentage of participants |
| TAK-019 0.5 mL | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 387 | 100.0 percentage of participants |
| TAK-019 0.5 mL | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 22 | 100.0 percentage of participants |
| TAK-019 0.5 mL | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 36 | 100.0 percentage of participants |
| TAK-019 0.5 mL | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 50 | 100.0 percentage of participants |
| TAK-019 0.5 mL | SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387 | Day 202 | 100.0 percentage of participants |