Trial Outcomes & Findings for A Study of TAK-919 in Healthy Japanese Adults (COVID-19) (NCT NCT04677660)
NCT ID: NCT04677660
Last Updated: 2023-05-03
Results Overview
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
COMPLETED
PHASE1/PHASE2
200 participants
Up to Day 7 (6 subsequent days after first vaccination on Day 1)
2023-05-03
Participant Flow
Participants took part in the study at 2 investigative sites in Japan from 07 January 2021 to 22 February 2022.
Healthy Japanese participants were enrolled to receive two doses of TAK-919 or saline placebo by intramuscular injection on Day 1 (first vaccination) and Day 29 (second vaccination).
Participant milestones
| Measure |
Placebo
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
TAK-919 0.5 milliliter (mL), injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
150
|
|
Overall Study
COMPLETED
|
7
|
137
|
|
Overall Study
NOT COMPLETED
|
43
|
13
|
Reasons for withdrawal
| Measure |
Placebo
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
TAK-919 0.5 milliliter (mL), injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Chose Publicly Available Vaccine
|
43
|
10
|
Baseline Characteristics
A Study of TAK-919 in Healthy Japanese Adults (COVID-19)
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.4 years
STANDARD_DEVIATION 14.18 • n=99 Participants
|
53.3 years
STANDARD_DEVIATION 15.67 • n=107 Participants
|
53.1 years
STANDARD_DEVIATION 15.28 • n=206 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
112 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
|
62.49 kilogram (kg)
STANDARD_DEVIATION 10.870 • n=99 Participants
|
61.05 kilogram (kg)
STANDARD_DEVIATION 9.918 • n=107 Participants
|
61.41 kilogram (kg)
STANDARD_DEVIATION 10.156 • n=206 Participants
|
|
Height
|
163.09 centimeter (cm)
STANDARD_DEVIATION 8.501 • n=99 Participants
|
164.83 centimeter (cm)
STANDARD_DEVIATION 8.549 • n=107 Participants
|
164.39 centimeter (cm)
STANDARD_DEVIATION 8.549 • n=206 Participants
|
|
Body Mass Index (BMI)
|
23.35 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.595 • n=99 Participants
|
22.39 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.653 • n=107 Participants
|
22.63 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.665 • 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, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Injection Site Pain
|
6.0 percentage of participants
|
82.7 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
|
2.0 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
|
10.7 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
|
6.0 percentage of participants
|
|
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Lymphadenopathy (Axillary Swelling or Tenderness at Same Side of Injection Site)
|
4.0 percentage of participants
|
11.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 35 (6 subsequent days after second vaccination on Day 29)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 were evaluable for this outcome measure.
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Injection Site Pain
|
2.0 percentage of participants
|
85.0 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Erythema/ Redness
|
0.0 percentage of participants
|
17.7 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Swelling
|
0.0 percentage of participants
|
16.3 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Induration
|
0.0 percentage of participants
|
12.9 percentage of participants
|
|
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Lymphadenopathy (Axillary Swelling or Tenderness at Same Side of Injection Site)
|
6.0 percentage of participants
|
10.2 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 headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Headache
|
0.0 percentage of participants
|
13.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Fatigue
|
10.0 percentage of participants
|
18.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Myalgia
|
4.0 percentage of participants
|
37.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Arthralgia
|
0.0 percentage of participants
|
8.0 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
Chills
|
2.0 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Fever
|
2.0 percentage of participants
|
2.0 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 35 (6 subsequent days after second vaccination on Day 29)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 were evaluable for this outcome measure.
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Headache
|
10.0 percentage of participants
|
47.6 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Fatigue
|
8.0 percentage of participants
|
63.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Myalgia
|
10.0 percentage of participants
|
49.7 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Arthralgia
|
0.0 percentage of participants
|
32.0 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Nausea/ Vomiting
|
0.0 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Chills
|
0.0 percentage of participants
|
50.3 percentage of participants
|
|
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Fever
|
0.0 percentage of participants
|
40.1 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 29 (28 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 is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs for 28 Days Following First Vaccination
|
18.0 percentage of participants
|
20.7 percentage of participants
|
PRIMARY outcome
Timeframe: Up to Day 57 (28 days after second vaccination on Day 29)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 were evaluable for this outcome measure.
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination
|
14.0 percentage of participants
|
19.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 57Population: 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 the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 57 was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 57Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 57 was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57
|
2.0 percentage of participants
|
5.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 57Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Only unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
|
0.0 percentage of participants
|
1.3 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 57Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 57 was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 57
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 57Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57
|
0.0 percentage of participants
|
0.0 percentage of participants
|
PRIMARY outcome
Timeframe: At Day 57Population: The per-protocol-set (PPS) included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment.
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below lower limit of quantification (LLOQ) were imputed to a value that is half of the LLOQ. Titer values measured as above upper limit of quantification (ULOQ) were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 spike (S) protein.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57
|
0.60 arbitrary unit per milliliter (AU/mL)
Interval 0.53 to 0.67
|
813.05 arbitrary unit per milliliter (AU/mL)
Interval 759.31 to 870.6
|
PRIMARY outcome
Timeframe: At Day 57Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment.
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57
|
0.90 fold change
Interval 0.83 to 0.99
|
1009.25 fold change
Interval 865.11 to 1177.4
|
PRIMARY outcome
Timeframe: At Day 57Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment.
SCR was defined as percentage of participants with a change from below limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ, OR, greater than or equal to (\>=) 4-fold rises from baseline. LLOQ= 1, ULOQ= 2052. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57
|
2.0 percentage of participants
Interval 0.1 to 10.6
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 394Population: 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 the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs throughout the trial was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With SAE Throughout the Trial
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 394Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs throughout the trial was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With MAAEs Throughout the Trial
|
4.0 percentage of participants
|
14.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 up to Day 394Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial from the day of vaccination throughout the trial was reported in this outcome measure.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in 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 394Population: The safety analysis set included all participants who received at least 1 dose of the treatment.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
|
0.0 percentage of participants
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Days 29, 43, 209 and 394Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints.
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 29
|
0.65 AU/mL
Interval 0.57 to 0.74
|
140.72 AU/mL
Interval 124.84 to 158.62
|
|
GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 43
|
0.62 AU/mL
Interval 0.55 to 0.7
|
1021.71 AU/mL
Interval 940.66 to 1109.73
|
|
GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 209
|
0.70 AU/mL
Interval 0.51 to 0.96
|
116.97 AU/mL
Interval 106.26 to 128.76
|
|
GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 394
|
1.28 AU/mL
Interval 0.38 to 4.33
|
53.36 AU/mL
Interval 46.74 to 60.92
|
SECONDARY outcome
Timeframe: At Days 29, 43, 209 and 394Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints.
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 29
|
0.99 fold change
Interval 0.9 to 1.08
|
174.67 fold change
Interval 148.72 to 205.16
|
|
GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 43
|
0.93 fold change
Interval 0.87 to 1.0
|
1268.26 fold change
Interval 1073.44 to 1498.43
|
|
GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 209
|
1.00 fold change
Interval 0.81 to 1.24
|
145.97 fold change
Interval 124.69 to 170.89
|
|
GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 394
|
1.71 fold change
Interval 0.44 to 6.63
|
65.01 fold change
Interval 53.96 to 78.32
|
SECONDARY outcome
Timeframe: At Days 29, 43, 209 and 394Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints.
SCR was defined as percentage of participants with a change from below LOD or LLOQ to equal to or above LOD or LLOQ, OR \>=4-fold rises from baseline. LLOQ= 1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 29
|
6.0 percentage of participants
Interval 1.3 to 16.5
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
|
SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 43
|
2.0 percentage of participants
Interval 0.1 to 10.6
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
|
SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 209
|
8.3 percentage of participants
Interval 0.2 to 38.5
|
99.3 percentage of participants
Interval 96.2 to 100.0
|
|
SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Day 394
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
97.0 percentage of participants
Interval 92.5 to 99.2
|
SECONDARY outcome
Timeframe: At Days 29, 43, 57, 209, and 394Population: PPS included participants in the FAS and who had evaluable immunogenicity data and did not have significant protocol deviations which influence the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints.
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ= 159.79 and ULOQ= 11173.11. GMT of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 29
|
79.9 microneutralization titers (MN50)
Interval 79.9 to 79.9
|
202.4 microneutralization titers (MN50)
Interval 170.5 to 240.2
|
|
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 43
|
79.9 microneutralization titers (MN50)
Interval 79.9 to 79.9
|
5977.3 microneutralization titers (MN50)
Interval 5456.5 to 6547.9
|
|
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 57
|
79.9 microneutralization titers (MN50)
Interval 79.9 to 79.9
|
1734.7 microneutralization titers (MN50)
Interval 1582.8 to 1901.2
|
|
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 209
|
79.9 microneutralization titers (MN50)
Interval 79.9 to 79.9
|
741.3 microneutralization titers (MN50)
Interval 630.2 to 872.0
|
|
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 394
|
79.9 microneutralization titers (MN50)
Interval 79.9 to 79.9
|
248.0 microneutralization titers (MN50)
Interval 202.8 to 303.2
|
SECONDARY outcome
Timeframe: At Days 29, 43, 57, 209, and 394Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints.
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 29
|
1.0 fold change
Interval 1.0 to 1.0
|
2.5 fold change
Interval 2.1 to 3.0
|
|
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 43
|
1.0 fold change
Interval 1.0 to 1.0
|
74.8 fold change
Interval 68.3 to 82.0
|
|
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 57
|
1.0 fold change
Interval 1.0 to 1.0
|
21.7 fold change
Interval 19.8 to 23.8
|
|
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 209
|
1.0 fold change
Interval 1.0 to 1.0
|
9.3 fold change
Interval 7.9 to 10.9
|
|
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 394
|
1.0 fold change
Interval 1.0 to 1.0
|
3.1 fold change
Interval 2.5 to 3.8
|
SECONDARY outcome
Timeframe: At Days 29, 43, 57, 209, and 394Population: The PPS included participants who received at least one dose of the treatment and who had evaluable immunogenicity data and did not have significant protocol deviations which influenced the immunogenicity assessment. Here, "number analyzed" signifies those participants who were evaluable for this outcome measure at given timepoints.
SCR was defined at percentage of participants with a change from below the LOD or LLOQ to equal to or above LLOQ, OR, \>=4-fold rises from baseline. LLOQ= 159.79 and ULOQ= 11173.11. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.
Outcome measures
| Measure |
Placebo
n=50 Participants
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=147 Participants
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 29
|
0.0 percentage of participants
Interval 0.0 to 7.1
|
56.1 percentage of participants
Interval 47.5 to 64.5
|
|
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 43
|
0.0 percentage of participants
Interval 0.0 to 7.1
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
|
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 57
|
0.0 percentage of participants
Interval 0.0 to 7.1
|
100.0 percentage of participants
Interval 97.5 to 100.0
|
|
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 209
|
0.0 percentage of participants
Interval 0.0 to 26.5
|
94.4 percentage of participants
Interval 89.3 to 97.6
|
|
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Day 394
|
0.0 percentage of participants
Interval 0.0 to 41.0
|
68.2 percentage of participants
Interval 59.4 to 76.1
|
Adverse Events
Placebo
TAK-919 0.5 mL
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 participants at risk
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.67%
1/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
TAK-919 placebo-matching, injection, intramuscularly, once on Days 1 and 29 in healthy participants.
|
TAK-919 0.5 mL
n=150 participants at risk
TAK-919 0.5 mL, injection, intramuscularly, once on Days 1 and 29 in 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Body temperature increased
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
40.0%
60/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
51.3%
77/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Fatigue
|
18.0%
9/50 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
64.7%
97/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
49.3%
74/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.0%
21/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pain
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
92.0%
138/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
60.7%
91/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
19.3%
29/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
18.7%
28/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vaccination site lymphadenopathy
|
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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
19.3%
29/150 • 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 29 (Day 394)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
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