Trial Outcomes & Findings for A Study of TAK-019 in Healthy Japanese Adults (COVID-19) (NCT NCT04712110)
NCT ID: NCT04712110
Last Updated: 2023-06-06
Results Overview
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.
COMPLETED
PHASE1/PHASE2
200 participants
Up to Day 28 (6 subsequent days after second vaccination on Day 22)
2023-06-06
Participant Flow
Participants took part in the study at 2 investigative sites in Japan from 12 February 2021 to 28 March 2022.
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).
Participant milestones
| Measure |
Placebo
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
TAK-019 0.5 milliliter (mL), injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
150
|
|
Overall Study
COMPLETED
|
4
|
131
|
|
Overall Study
NOT COMPLETED
|
46
|
19
|
Reasons for withdrawal
| Measure |
Placebo
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
TAK-019 0.5 milliliter (mL), injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
|
Overall Study
Chose Publicly Available SARS-CoV-2 Vaccine
|
46
|
14
|
Baseline Characteristics
A Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.8 years
STANDARD_DEVIATION 16.42 • n=99 Participants
|
52.6 years
STANDARD_DEVIATION 15.80 • n=107 Participants
|
52.2 years
STANDARD_DEVIATION 15.93 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
50 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Region of Enrollment
Japan
|
50 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Weight
|
61.73 kilogram (kg)
STANDARD_DEVIATION 11.806 • n=99 Participants
|
62.94 kilogram (kg)
STANDARD_DEVIATION 10.485 • n=107 Participants
|
62.64 kilogram (kg)
STANDARD_DEVIATION 10.813 • n=206 Participants
|
|
Height
|
164.00 centimeter (cm)
STANDARD_DEVIATION 9.157 • n=99 Participants
|
164.10 centimeter (cm)
STANDARD_DEVIATION 8.596 • n=107 Participants
|
164.08 centimeter (cm)
STANDARD_DEVIATION 8.716 • n=206 Participants
|
|
Body Mass Index (BMI)
|
22.80 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.865 • n=99 Participants
|
23.29 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.850 • n=107 Participants
|
23.17 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.854 • n=206 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Injection site pain
|
4.0 percentage of participants
|
29.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Tenderness
|
4.0 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Erythema/redness
|
0.0 percentage of participants
|
2.7 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Induration
|
0.0 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Swelling
|
0.0 percentage of participants
|
2.7 percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Injection site pain
|
2.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Tenderness
|
4.1 percentage of participants
|
62.7 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Erythema/redness
|
0.0 percentage of participants
|
15.3 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Induration
|
0.0 percentage of participants
|
11.3 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Swelling
|
0.0 percentage of participants
|
17.3 percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Fever
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Fatigue
|
6.0 percentage of participants
|
8.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Malaise
|
4.0 percentage of participants
|
10.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Myalgia
|
4.0 percentage of participants
|
17.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Arthralgia
|
0.0 percentage of participants
|
4.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Nausea/vomiting
|
0.0 percentage of participants
|
0.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Headache
|
2.0 percentage of participants
|
10.7 percentage of participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Fever
|
0.0 percentage of participants
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Fatigue
|
8.2 percentage of participants
|
20.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Malaise
|
6.1 percentage of participants
|
29.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Myalgia
|
4.1 percentage of participants
|
32.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Arthralgia
|
0.0 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Nausea/vomiting
|
0.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Headache
|
2.0 percentage of participants
|
21.3 percentage of participants
|
PRIMARY outcome
Timeframe: 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.
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs for 20 Days Following First Vaccination
|
8.0 percentage of participants
|
10.0 percentage of participants
|
PRIMARY outcome
Timeframe: 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.
Unsolicited AEs were all AEs that were not pre-defined for which the participant was not specifically questioned in the participant diary.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs for 27 Days Following Second Vaccination
|
12.2 percentage of participants
|
29.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 50Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Until Day 50
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 50Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Adverse Events of Special Interest (AESI) Until Day 50
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 50Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 50
|
4.0 percentage of participants
|
2.7 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 22Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
|
2.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 50Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 50
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 50Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 50
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: At Day 36Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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)
Interval 109.6 to 159.5
|
31036.8 ELISA units per mL (EU/mL)
Interval 26837.1 to 35893.7
|
PRIMARY outcome
Timeframe: At Day 36Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
|
1.0 fold change
Interval 1.0 to 1.1
|
258.8 fold change
Interval 218.8 to 306.0
|
PRIMARY outcome
Timeframe: At Day 36Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
PRIMARY outcome
Timeframe: At Day 36Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Seroresponse Rate (SRR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 36
|
8.2 percentage of participants
Interval 2.3 to 19.6
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 387Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With SAE Throughout the Trial
|
2.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 387Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With AESI Throughout the Trial
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 387Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With MAAEs Throughout the Trial
|
6.0 percentage of participants
|
10.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 387Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
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.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 387Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
|
2.0 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: At Days 22, 50, 202, and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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
Interval 115.2 to 182.4
|
1390.0 EU/mL
Interval 1140.8 to 1693.7
|
|
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
Interval 109.3 to 166.2
|
23910.8 EU/mL
Interval 20737.0 to 27570.3
|
|
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
Interval 26.0 to 27800.8
|
4390.1 EU/mL
Interval 3600.9 to 5352.3
|
|
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
Interval 15.2 to 3674.6
|
3461.2 EU/mL
Interval 2601.5 to 4605.1
|
SECONDARY outcome
Timeframe: At Days 22, 50, 202, and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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
Interval 0.2 to 36.7
|
27.9 fold change
Interval 20.7 to 37.6
|
|
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
Interval 1.0 to 1.2
|
11.6 fold change
Interval 9.4 to 14.2
|
|
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
Interval 1.0 to 1.1
|
199.1 fold change
Interval 169.2 to 234.3
|
|
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
Interval 0.3 to 278.0
|
36.4 fold change
Interval 29.8 to 44.6
|
SECONDARY outcome
Timeframe: At Days 22, 50, 202, and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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
Interval 1.3 to 16.9
|
82.7 percentage of participants
Interval 75.6 to 88.4
|
|
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
Interval 0.1 to 10.9
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
|
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
Interval 4.3 to 77.7
|
97.9 percentage of participants
Interval 94.1 to 99.6
|
|
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
Interval 0.6 to 80.6
|
96.9 percentage of participants
Interval 92.1 to 99.1
|
SECONDARY outcome
Timeframe: At Days 22, 50, 202, and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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
Interval 3.4 to 22.2
|
84.0 percentage of participants
Interval 77.1 to 89.5
|
|
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
Interval 4.6 to 24.8
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
|
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
Interval 4.3 to 77.7
|
97.9 percentage of participants
Interval 94.1 to 99.6
|
|
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
Interval 0.6 to 80.6
|
96.9 percentage of participants
Interval 92.1 to 99.1
|
SECONDARY outcome
Timeframe: At Days 22, 36, 50, 202 and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
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
Interval 9.9 to 10.9
|
50.2 1 per dilution
Interval 41.2 to 61.0
|
|
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
Interval 9.9 to 10.9
|
884.4 1 per dilution
Interval 749.0 to 1044.4
|
|
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
Interval 9.9 to 10.9
|
509.5 1 per dilution
Interval 422.5 to 614.6
|
|
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
Interval 3.6 to 698.8
|
65.5 1 per dilution
Interval 53.4 to 80.4
|
|
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
Interval 4.7 to 42.6
|
65.7 1 per dilution
Interval 49.0 to 88.1
|
SECONDARY outcome
Timeframe: At Days 22, 36, 50, 202 and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 22
|
1.0 fold change
Interval 1.0 to 1.1
|
5.0 fold change
Interval 4.1 to 6.1
|
|
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 36
|
1.0 fold change
Interval 1.0 to 1.1
|
88.0 fold change
Interval 74.5 to 104.0
|
|
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 50
|
1.0 fold change
Interval 1.0 to 1.1
|
50.7 fold change
Interval 42.0 to 61.2
|
|
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 202
|
5.0 fold change
Interval 0.4 to 69.9
|
6.5 fold change
Interval 5.3 to 8.0
|
|
GMFR of Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 387
|
1.4 fold change
Interval 0.5 to 4.3
|
6.5 fold change
Interval 4.9 to 8.7
|
SECONDARY outcome
Timeframe: At Days 22, 36, 50, 202 and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 22
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
67.3 percentage of participants
Interval 59.2 to 74.8
|
|
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 36
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
99.3 percentage of participants
Interval 96.3 to 100.0
|
|
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 50
|
0.0 percentage of participants
Interval 0.0 to 7.3
|
98.0 percentage of participants
Interval 94.2 to 99.6
|
|
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 202
|
33.3 percentage of participants
Interval 4.3 to 77.7
|
76.0 percentage of participants
Interval 68.3 to 82.7
|
|
SCR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 387
|
25.0 percentage of participants
Interval 0.6 to 80.6
|
70.9 percentage of participants
Interval 62.1 to 78.6
|
SECONDARY outcome
Timeframe: At Days 22, 36, 50, 202 and 387Population: 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.
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.
Outcome measures
| Measure |
Placebo
n=49 Participants
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019 0.5 mL
n=150 Participants
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 22
|
100.0 percentage of participants
Interval 92.7 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
|
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 36
|
100.0 percentage of participants
Interval 92.7 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
|
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 50
|
100.0 percentage of participants
Interval 92.7 to 100.0
|
100.0 percentage of participants
Interval 97.6 to 100.0
|
|
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 202
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
|
SRR to Serum nAb Titers to Wild Type Virus on Days 22, 36, 50, 202 and 387
Day 387
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
100.0 percentage of participants
Interval 97.1 to 100.0
|
Adverse Events
Placebo
TAK-019
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019
n=150 participants at risk
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
2.0%
1/50 • 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.
|
0.00%
0/150 • 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.
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
TAK-019 placebo-matching, injection, intramuscularly once on Days 1 and 22 in the healthy participants.
|
TAK-019
n=150 participants at risk
TAK-019 0.5 mL, injection, intramuscularly, once on Days 1 and 22 in the healthy participants.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • 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.
|
16.0%
24/150 • 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.
|
|
Investigations
Body temperature increased
|
0.00%
0/50 • 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.
|
6.0%
9/150 • 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.
|
|
General disorders
Fatigue
|
14.0%
7/50 • 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.
|
26.0%
39/150 • 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.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • 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.
|
27.3%
41/150 • 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.
|
|
General disorders
Induration
|
0.00%
0/50 • 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.
|
13.3%
20/150 • 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.
|
|
General disorders
Injection site pain
|
6.0%
3/50 • 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.
|
58.7%
88/150 • 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.
|
|
General disorders
Injection site pruritus
|
0.00%
0/50 • 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.
|
17.3%
26/150 • 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.
|
|
General disorders
Malaise
|
12.0%
6/50 • 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.
|
33.3%
50/150 • 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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
4/50 • 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.
|
37.3%
56/150 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/50 • 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.
|
6.0%
9/150 • 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.
|
|
General disorders
Swelling
|
0.00%
0/50 • 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.
|
18.0%
27/150 • 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.
|
|
General disorders
Tenderness
|
6.0%
3/50 • 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.
|
66.7%
100/150 • 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.
|
|
General disorders
Vaccination site erythema
|
0.00%
0/50 • 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.
|
17.3%
26/150 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER