Coronavirus Disease (COVID-19)Phase 1/2NCT04677660
A Study of TAK-919 in Healthy Japanese Adults (COVID-19)
A Phase 1/2 study testing TAK-919 in people with Coronavirus Disease (COVID-19), run by Takeda at 2 sites in Japan.
Trial summary
TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919. At the first visit, the study doctor will check if each person can take part. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease (COVID-19)
- What is being tested?
- TAK-919
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesJapan
- Study dates
- 7 Jan 2021to 22 Feb 2022
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Japanese male and female participants.
- Participants who understand and are willing to comply with trial procedures and are available for the duration of follow up.
Who cannot join
- Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
- Participants who have close contact of anyone known to have COVID-19 within 30 days prior to vaccine administration.
- Participants who were tested positive for SARS-CoV-2 prior to the trial or on the test before the vaccination.
- Participants who are on current treatment with other investigational agents for prophylaxis of COVID 19.
- Participants who traveled outside of Japan in the 30 days prior to the trial participation.
- Participants with a clinically significant active infection (as assessed by the Investigator) or oral temperature >= 38 degree Celsius within 3 days of the vaccination.
Show all 19Show fewer
- Participants with a known hypersensitivity or allergy to any of the IMP components.
- Participants with any illness or history of any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
- Participants with known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
- Abnormalities of splenic or thymic function.
- Participants with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Participants with any serious chronic or progressive disease (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
- Participants with BMI >= 30 kg/m^2 (BMI=weight in kg/height in meters^2).
- Participants participating in any clinical trial with another investigational product within 30 days prior to the vaccination or intend to participate in another clinical trial at any time during the conduct of this trial.
- Participants who received or plan to receive any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to trial dose administration.
- Participants with acute or chronic clinically significant disease including pulmonary, cardiovascular, hepatic, or renal abnormality evaluated by physical examination.
- Participants involved in the trial conduct or their first-degree relatives.
- Participants who are with or have history of hepatitis B and hepatitis C infection, or with known human immunodeficiency virus (HIV) infection or HIV-related disease..
- Female participants who are pregnant or breastfeeding.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919.
At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-919 or a placebo in their arm. In this study, a placebo will look like the TAK-919 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-919 than placebo. Participants will receive 2 injections of TAK-919 or placebo, 28 days apart.
Read more
Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection.
During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have visited their clinic 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.
The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-919 or the placebo.
Read the detailed description
The drug being tested in this study is called TAK-919. TAK-919 is being tested to prevent infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2). This study will look at the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults, given 28 days apart.
The study will enroll approximately 200 healthy volunteers. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-919 0.5 mL
- Placebo- this is an injection that looks like the study drug but has no active ingredient
All participants will be asked to take intramuscular injection in the upper arm twice throughout the study.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is 12 months from the second vaccination. Participants will make multiple visits to the clinic and will be contacted by telephone or a final visit after the last vaccination for a follow-up assessment.
- Conditions
- Coronavirus Disease (COVID-19)
- Being tested
- TAK-919, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-919Biological
TAK-919 intramuscular injection
PlaceboBiological
Placebo intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| TAK-919 | Experimental | TAK-919 0.5 mL, intramuscular injection in the upper arm Receives: Biological: TAK-919 |
| Placebo | Placebo comparator | TAK-919 Matching Placebo, intramuscular injection in the upper arm Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Measured: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Measured: Up to Day 35 (6 subsequent days after second vaccination on Day 29)
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Measured: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following second vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Measured: Up to Day 35 (6 subsequent days after second vaccination on Day 29)
Percentage of Participants With Unsolicited AEs for 28 Days Following First Vaccination
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Measured: Up to Day 29 (28 days after first vaccination on Day 1)
Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Measured: Up to Day 57 (28 days after second vaccination on Day 29)
Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this outcome measure (OM) and solicited SAE was out of the scope of the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 57 was reported in this outcome measure.
Measured: Day 1 up to Day 57
Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57
MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 57 was reported in this outcome measure.
Measured: Day 1 up to Day 57
Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
Only unsolicited AE leading to discontinuation of vaccination data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to discontinuation of vaccination was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to discontinuation of vaccination was reported in this outcome measure.
Measured: Day 1 up to Day 57
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 57
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 57 was reported in this outcome measure.
Measured: Day 1 up to Day 57
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57
Measured: Day 1 up to Day 57
Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below lower limit of quantification (LLOQ) were imputed to a value that is half of the LLOQ. Titer values measured as above upper limit of quantification (ULOQ) were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 spike (S) protein.
Measured: At Day 57
Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measured: At Day 57
Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57
SCR was defined as percentage of participants with a change from below limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ, OR, greater than or equal to (>=) 4-fold rises from baseline. LLOQ= 1, ULOQ= 2052. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measured: At Day 57
Secondary outcomes (10)
Percentage of Participants With SAE Throughout the Trial
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this OM and solicited SAE was out of the scope of the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs throughout the trial was reported in this outcome measure.
Measured: Day 1 up to Day 394
Percentage of Participants With MAAEs Throughout the Trial
MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs throughout the trial was reported in this outcome measure.
Measured: Day 1 up to Day 394
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial from the day of vaccination throughout the trial was reported in this outcome measure.
Measured: Day 1 up to Day 394
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
Measured: Day 1 up to Day 394
GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measured: At Days 29, 43, 209 and 394
GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measured: At Days 29, 43, 209 and 394
SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
SCR was defined as percentage of participants with a change from below LOD or LLOQ to equal to or above LOD or LLOQ, OR >=4-fold rises from baseline. LLOQ= 1 and ULOQ= 2052 until Day 43; LLOQ= 1 and ULOQ= 20520 from Day 209 and later. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Measured: At Days 29, 43, 209 and 394
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below LLOQ were imputed to a value that is half of the LLOQ. Titer values measured as above ULOQ were imputed at the ULOQ value. LLOQ= 159.79 and ULOQ= 11173.11. GMT of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.
Measured: At Days 29, 43, 57, 209, and 394
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.
Measured: At Days 29, 43, 57, 209, and 394
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
SCR was defined at percentage of participants with a change from below the LOD or LLOQ to equal to or above LLOQ, OR, >=4-fold rises from baseline. LLOQ= 159.79 and ULOQ= 11173.11. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum nAb against SARS-CoV-2 was measured by assay specific to wild-type virus.
Measured: At Days 29, 43, 57, 209, and 394
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start7 Jan 2021
- Primary completion22 Feb 2022
- Study completion22 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease (COVID-19)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677660
- Sponsor's protocol ID
- TAK-919-1501
- Other IDs
- U1111-1261-9040, jRCT2071200069
- Status last verified
- Feb 2023
- First submitted
- 18 Dec 2020
- Last updated
- 3 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Masuda T, Murakami K, Sugiura K, Sakui S, Philip Schuring R, Mori M. A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report. Vaccine. 2022 Mar 18;40(13):2044-2052. doi: 10.1016/j.vaccine.2022.02.030. Epub 2022 Feb 8.
PubMed 35177302
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of TAK-919 by Intramuscular Injection in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)
- ClinicalTrials.gov ID
- NCT04677660
- Acronym / sponsor ID
- TAK-919-1501
- Conditions
- Coronavirus Disease (COVID-19)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 22 Feb 2022 (actual)
- Study completion
- 22 Feb 2022 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Posted 3 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TAK-919 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-919 can protect people from Covid-19 and to check for side effects from TAK-919.
At the first visit, the study doctor will check if each person can take part. Those who can take part will be chosen for 1 of 2 treatments by chance. Participants will either receive an injection of TAK-919 or a placebo in their arm. In this study, a placebo will look like the TAK-919 vaccine but will not have any medicine in it. 3 times as many participants will receive TAK-919 than placebo. Participants will receive 2 injections of TAK-919 or placebo, 28 days apart.
Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after each injection.
During the study, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have visited their clinic 28 days after their 2nd injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.
The participants will stay in the study for up to 12 months after they have had their 2nd injection. During this time, the study doctors will continue to check how many participants have made enough antibodies to protect them against Covid-19. Also, they will check if participants have any more side effects from TAK-919 or the placebo.
Detailed description
The drug being tested in this study is called TAK-919. TAK-919 is being tested to prevent infectious disease caused by Severe Acute Respiratory Syndrome coronavirus-2 (SARS-CoV-2). This study will look at the safety and immunogenicity of 2 doses of TAK-919 by intramuscular (IM) injection in healthy Japanese male and female adults, given 28 days apart.
The study will enroll approximately 200 healthy volunteers. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
- TAK-919 0.5 mL
- Placebo- this is an injection that looks like the study drug but has no active ingredient
All participants will be asked to take intramuscular injection in the upper arm twice throughout the study.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is 12 months from the second vaccination. Participants will make multiple visits to the clinic and will be contacted by telephone or a final visit after the last vaccination for a follow-up assessment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-919 | Experimental | Biological: TAK-919TAK-919 0.5 mL, intramuscular injection in the upper arm |
| Placebo | Placebo comparator | Biological: PlaceboTAK-919 Matching Placebo, intramuscular injection in the upper arm |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Japanese male and female participants.
- Participants who understand and are willing to comply with trial procedures and are available for the duration of follow up.
Key exclusion criteria (19 listed)
- Participants who received any other SARS-CoV-2 or other experimental novel coronavirus vaccine prior to the trial.
- Participants who have close contact of anyone known to have COVID-19 within 30 days prior to vaccine administration.
- Participants who were tested positive for SARS-CoV-2 prior to the trial or on the test before the vaccination.
- Participants who are on current treatment with other investigational agents for prophylaxis of COVID 19.
- Participants who traveled outside of Japan in the 30 days prior to the trial participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-919TAK-919 intramuscular injection | Biological | TAK-919 |
| PlaceboPlacebo intramuscular injection | Biological | Placebo |
Primary outcome
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination
Time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Solicited local AEs were pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited local AEs included injection site pain, erythema/redness, swelling, induration, and axillary (underarm) swelling or tenderness ipsilateral to the side of injection.
Percentage of Participants With Solicited Local AEs for Six Subsequent Days Following Second Vaccination
Time frame: Up to Day 35 (6 subsequent days after second vaccination on Day 29)
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.
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following First Vaccination
Time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)
Solicited systemic AEs were pre-defined AEs for which participants were specifically questioned and which were noted by participants in their diary for six subsequent days following first vaccination. Solicited systemic AEs included headache, fatigue, myalgia, arthralgia, nausea/ vomiting, chills, fever.
Percentage of Participants With Solicited Systemic AEs for Six Subsequent Days Following Second Vaccination
Time frame: Up to Day 35 (6 subsequent days after second vaccination on Day 29)
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.
Percentage of Participants With Unsolicited AEs for 28 Days Following First Vaccination
Time frame: Up to Day 29 (28 days after first vaccination on Day 1)
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Percentage of Participants With Unsolicited AEs for 28 Days Following Second Vaccination
Time frame: Up to Day 57 (28 days after second vaccination on Day 29)
Unsolicited AEs were all AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary.
Percentage of Participants With Serious Adverse Events (SAEs) Until Day 57
Time frame: Day 1 up to Day 57
Only unsolicited SAEs data was planned to be collected and assessed for the assessment of this outcome measure (OM) and solicited SAE was out of the scope of the assessment. Unsolicited SAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited SAEs until Day 57 was reported in this outcome measure.
Percentage of Participants With Medically-Attended Adverse Events (MAAEs) Until Day 57
Time frame: Day 1 up to Day 57
MAAEs were defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Only unsolicited MAAEs data was planned to be collected and assessed for the assessment of this OM and solicited MAAEs was out of the scope of the assessment. Unsolicited MAAEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with unsolicited MAAEs until Day 57 was reported in this outcome measure.
Percentage of Participants With Any AE Leading to Discontinuation of Vaccination
Time frame: Day 1 up to Day 57
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.
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial Until Day 57
Time frame: Day 1 up to Day 57
Only unsolicited AE leading to participant's withdrawal data was planned to be collected and assessed for the assessment of this OM and solicited AE leading to participant's withdrawal was out of the scope of the assessment. Unsolicited AEs were those AEs that were not pre-defined for which the participant is not specifically questioned in the participant diary. Percentage of participants with any unsolicited AE leading to participant's withdrawal from the trial until Day 57 was reported in this outcome measure.
Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Infection Until Day 57
Time frame: Day 1 up to Day 57
Geometric Mean Titers (GMT) of Serum Binding Antibody (bAb) Against SARS-CoV-2 on Day 57
Time frame: At Day 57
GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average for each group. Titer values measured as below lower limit of quantification (LLOQ) were imputed to a value that is half of the LLOQ. Titer values measured as above upper limit of quantification (ULOQ) were imputed at the ULOQ value. LLOQ=1 and ULOQ= 2052. GMT of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 spike (S) protein.
Geometric Mean Fold Rise (GMFR) of Serum bAb Against SARS-CoV-2 on Day 57
Time frame: At Day 57
The GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titer level. Where baseline was defined as the last measurement taken before the first dose of study intervention. GMFR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
Seroconversion Rate (SCR) of Serum bAb Against SARS-CoV-2 on Day 57
Time frame: At Day 57
SCR was defined as percentage of participants with a change from below limit of detection (LOD) or LLOQ to equal to or above LOD or LLOQ, OR, greater than or equal to (>=) 4-fold rises from baseline. LLOQ= 1, ULOQ= 2052. Baseline was defined as the last measurement taken before the first dose of study intervention. SCR of serum bAb against SARS-CoV-2 was measured by ligand-binding assay specific to the SARS-CoV-2 S protein.
10 secondary outcomes
Percentage of Participants With SAE Throughout the Trial
Time frame: Day 1 up to Day 394
Percentage of Participants With MAAEs Throughout the Trial
Time frame: Day 1 up to Day 394
Percentage of Participants With Any AE Leading to Participant's Withdrawal From the Trial From the Day of Vaccination Throughout the Trial
Time frame: Day 1 up to Day 394
Percentage of Participants With SARS-CoV-2 Infection Throughout the Trial
Time frame: Day 1 up to Day 394
GMT of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Time frame: At Days 29, 43, 209 and 394
GMFR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Time frame: At Days 29, 43, 209 and 394
SCR of Serum bAb Against SARS-CoV-2 on Days 29, 43, 209 and 394
Time frame: At Days 29, 43, 209 and 394
GMT of Serum Neutralizing Antibody (nAb) Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Time frame: At Days 29, 43, 57, 209, and 394
GMFR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Time frame: At Days 29, 43, 57, 209, and 394
SCR of Serum nAb Against SARS-CoV-2 on Days 29, 43, 57, 209, and 394
Time frame: At Days 29, 43, 57, 209, and 394
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35177302Masuda T, Murakami K, Sugiura K, Sakui S, Philip Schuring R, Mori M. A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report. Vaccine. 2022 Mar 18;40(13):2044-2052. doi: 10.1016/j.vaccine.2022.02.030. Epub 2022 Feb 8.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAK-919 in people with Coronavirus Disease (COVID-19), run by Takeda at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Solicited Local Adverse Events (AEs) for Six Subsequent Days Following First Vaccination (time frame: Up to Day 7 (6 subsequent days after first vaccination on Day 1)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04677660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2023.