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JRCT ID: jRCT2071210141

Registered date:30/03/2022

A S ingle Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)

Basic Information

Recruitment status	Complete
Health condition(s) or Problem(s) studied	Coronavirus Disease (COVID-19)
Date of first enrollment	15/04/2022
Target sample size	150
Countries of recruitment
Study type	Interventional
Intervention(s)	MAIN PART: TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm EXTENSION PART: TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm. The participants who received the first single booster vaccination of TAK-019 in the main part and remained in study follow-up at least 5 months will receive a second single booster vaccination of TAK-019 by intramuscular injection.

TO Original Data: JRCT

Outcome(s)

Primary Outcome	1.Main Part: Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared with that Observed on Day 36 in Participants from the TAK-019-1501 Study Time Frame: Day 15 (14 days after the vaccination) ; Day 36 for TAK-019-1501 study (14 days after the second vaccination) 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 20. GMT for each group and GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in participants from the TAK-019-1501 study (NCT04712110) were reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36. Here, ELISA is Enzyme-linked immunosorbent assay. 2.Main Part: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination Time Frame: Main Part: 7 days after the first single booster vaccination AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling. 3.Main Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination Time Frame: Main Part: 7 days after the first single booster vaccination Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache. 4.Main Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the First Single Booster Vaccination Time Frame: Main Part: 28 days after the first single booster vaccination Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs. 5.Main Part: Percentage of Participants with Solicited and Unsolicited Serious Adverse Events (SAE) until Day 29 Time Frame: Main Part: Up to Day 29 An SAE was defined as any untoward medical occurrence that: Results in death, is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event. Solicited SAEs and Unsolicited SAEs were reported. 6.Main Part: Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 29 Time Frame: Main Part: Up to Day 29 An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study include the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; Neuroinflammatory Disorders, Musculoskeletal and Connective Tissue Disorders, Vasculitides, Gastrointestinal Disorders, Hepatic Disorders, Renal Disorders, Cardiac Disorders, Skin Disorder, Hematologic Disorders, Metabolic Disorders, and Other Disorders. 7.Main Part: Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 29 Time Frame: Main Part: Up to Day 29 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. 8.Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 29 Time Frame: Main Part: Up to Day 29 Percentage of participants with any AE leading to withdrawal from the trial until Day 29 was reported. 9.Main Part: Percentage of Participants with SARS-CoV-2 Infection until Day 29 Time Frame: Main Part: Up to Day 29 Percentage of participants with SARS-CoV-2 infection until Day 29 of the main part of the trial were reported in this outcome measure.
Secondary Outcome	1.Main Part: GMT of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. LLOQ was equal to 200 EU/mL. 2.Main Part: Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titter level. Where baseline was defined as the last measurement taken before the first dose of trial vaccination. 3.Main Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 SCR was defined at percentage of participants with >= 4-fold rises from baseline in titer . Baseline was defined as the last measurement taken before the first dose of trial vaccination. 4.Main Part: GMT of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 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. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ where LLOQ was equal to 20. 5.Main Part: GMFR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 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 trial vaccination. 6.Main Part: SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 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). SCR was defined at percentage of participants with >= 4-fold rises from baseline. Baseline was defined as the last measurement taken before the first dose of trial vaccination. 7.Main Part: Percentage of Participants with Solicited and Unsolicited SAE throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 8.Main Part: Percentage of Participants with AESI throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 9.Main Part: Percentage of Participants with MAAEs throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 10.Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of the First Single Booster Vaccination throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 11.Main Part: Percentage of Participants with SARS-CoV-2 Infection throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 12.Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366 Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 13.Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366 Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 14.Extension Part: SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366 Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 SCR is defined at percentage of participants with >= 4-fold rises in titer from extension part baseline. Where extension part baseline was defined as last measurement taken before the second booster vaccination. 15.Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366. Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 16.Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366. Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 17.Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366. Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 18.Extension Part: Percentage of Participants with Reported Solicited Local AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part Time Frame: Extension Part: 7 days after the second single booster vaccination 19.Extension Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part Time Frame: Extension Part: 7 days after the second single booster vaccination 20.Extension Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the Second Single Booster Vaccination in Extension Part Time Frame: Extension Part: 28 days after the second single booster vaccination 21.Extension Part: Percentage of Participants with Solicited and Unsolicited SAEs until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 22.Extension Part: Percentage of Participants with AESIs until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 23.Extension Part: Percentage of Participants with MAAEs until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 24.Extension Part: Percentage of Participants with any AEs Leading to Participant's Withdrawal from the Trial until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 25.Extension Part: Percentage of Participants with SARS-CoV-2 Infection until Extension Part Day 29. Time Frame: Extension Part: Up to Day 29 26.Extension Part: Percentage of Participants with Solicited and Unsolicited SAEs throughout the Extension Part of the Trial Time Frame: Extension Part: Up to Day 366 27.Extension Part: Percentage of Participants with AESIs throughout the Extension Part of the Trial Time Frame: Extension Part: Up to Day 366 28.Extension Part: Percentage of Participants with MAAEs throughout the Extension Part of the Trial Time Frame: Extension Part: Up to Day 366 29.Extension Part: Percentage of Participants with any AEs Leading to Participant's Withdrawal from the Trial from the Day of the Second Single Booster Vaccination throughout the Extension Part of the Trial Time Frame: Extension Part: From Day 1 to Day 366 30.Extension Part: Percentage of Participants with SARS-CoV-2 infection throughout the Extension Part of Trial Time Frame: Extension Part: Up to Day 366

Primary Outcome

1.Main Part: Geometric Mean Titers (GMT) Ratio of Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Day 15 Compared with that Observed on Day 36 in Participants from the TAK-019-1501 Study Time Frame: Day 15 (14 days after the vaccination) ; Day 36 for TAK-019-1501 study (14 days after the second vaccination) 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 20. GMT for each group and GMT ratio of neutralizing antibody titers to the ancestral strain (wild-type virus) on Day15 after a single booster vaccination (14 days after the booster vaccination) compared with that observed on Day 36 (14 days after the second vaccination) in participants from the TAK-019-1501 study (NCT04712110) were reported. GMT ratio was calculated with GMT of TAK-019-3001 on Day 15 divided by GMT of TAK-019-1501 study on Day 36. Here, ELISA is Enzyme-linked immunosorbent assay. 2.Main Part: Percentage of Participants with Reported Solicited Local Adverse Events (AEs) for 7 Days Following the First Single Booster Vaccination Time Frame: Main Part: 7 days after the first single booster vaccination AE was defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product (IMP); it did not necessarily have to have a causal relationship with IMP administration. Reported solicited local AEs were defined as injection site pain, tenderness, erythema/redness, induration, and swelling. 3.Main Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the First Single Booster Vaccination Time Frame: Main Part: 7 days after the first single booster vaccination Solicited systemic AEs were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting, and headache. 4.Main Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the First Single Booster Vaccination Time Frame: Main Part: 28 days after the first single booster vaccination Unsolicited AEs defines as other AEs than solicited local AEs and solicited systemic AEs. 5.Main Part: Percentage of Participants with Solicited and Unsolicited Serious Adverse Events (SAE) until Day 29 Time Frame: Main Part: Up to Day 29 An SAE was defined as any untoward medical occurrence that: Results in death, is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity, Leads to a congenital anomaly/birth defect in the offspring of a participant, or Is an important medical event. Solicited SAEs and Unsolicited SAEs were reported. 6.Main Part: Percentage of Participants with Adverse Event of Special Interest (AESI) until Day 29 Time Frame: Main Part: Up to Day 29 An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study include the Potential Immune Mediated Medical Conditions (PIMMC) and AEs specific to COVID-19. PIMMC is categorized as following; Neuroinflammatory Disorders, Musculoskeletal and Connective Tissue Disorders, Vasculitides, Gastrointestinal Disorders, Hepatic Disorders, Renal Disorders, Cardiac Disorders, Skin Disorder, Hematologic Disorders, Metabolic Disorders, and Other Disorders. 7.Main Part: Percentage of Participants with Medically-Attended Adverse Events (MAAEs) until Day 29 Time Frame: Main Part: Up to Day 29 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. 8.Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial until Day 29 Time Frame: Main Part: Up to Day 29 Percentage of participants with any AE leading to withdrawal from the trial until Day 29 was reported. 9.Main Part: Percentage of Participants with SARS-CoV-2 Infection until Day 29 Time Frame: Main Part: Up to Day 29 Percentage of participants with SARS-CoV-2 infection until Day 29 of the main part of the trial were reported in this outcome measure.

Secondary Outcome

1.Main Part: GMT of Serum Immunoglobulin G (IgG) Antibody Levels to SARS-CoV-2 Recombinant Spike (rS) Protein on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 GMT was the immunogenicity outcome expressed as reciprocal antibody titer with average. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ. LLOQ was equal to 200 EU/mL. 2.Main Part: Geometric Mean Fold Rise (GMFR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 GMFR was calculated as the ratio of the post-vaccination titer level to the baseline titter level. Where baseline was defined as the last measurement taken before the first dose of trial vaccination. 3.Main Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 SCR was defined at percentage of participants with >= 4-fold rises from baseline in titer . Baseline was defined as the last measurement taken before the first dose of trial vaccination. 4.Main Part: GMT of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 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. Titer values was measured as below LLOQ were imputed to a value that was half of the LLOQ where LLOQ was equal to 20. 5.Main Part: GMFR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 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 trial vaccination. 6.Main Part: SCR of Serum Neutralizing Antibody Titters to the Ancestral Strain (Wild-type Virus) on Day 8, 15, 29, 91, 181, and 366 Time Frame: Main Part: Day 8, 15, 29, 91, 181, and 366 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). SCR was defined at percentage of participants with >= 4-fold rises from baseline. Baseline was defined as the last measurement taken before the first dose of trial vaccination. 7.Main Part: Percentage of Participants with Solicited and Unsolicited SAE throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 8.Main Part: Percentage of Participants with AESI throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 9.Main Part: Percentage of Participants with MAAEs throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 10.Main Part: Percentage of Participants with Any AE Leading to Participant's Withdrawal from the Trial from the Day of the First Single Booster Vaccination throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 11.Main Part: Percentage of Participants with SARS-CoV-2 Infection throughout the Main Part of Trial Time Frame: Main Part: Up to Day 366 12.Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366 Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 13.Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366 Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 14.Extension Part: SCR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366 Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 SCR is defined at percentage of participants with >= 4-fold rises in titer from extension part baseline. Where extension part baseline was defined as last measurement taken before the second booster vaccination. 15.Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366. Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 16.Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366. Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 17.Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, Day 29, Day 91, Day 181, and Day 366. Time Frame: Extension Part: Day 15, 29, 91, 181, and 366 18.Extension Part: Percentage of Participants with Reported Solicited Local AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part Time Frame: Extension Part: 7 days after the second single booster vaccination 19.Extension Part: Percentage of Participants with Solicited Systemic AEs for 7 Days Following the Second Single Booster Vaccination in Extension Part Time Frame: Extension Part: 7 days after the second single booster vaccination 20.Extension Part: Percentage of Participants with Unsolicited AEs for 28 Days Following the Second Single Booster Vaccination in Extension Part Time Frame: Extension Part: 28 days after the second single booster vaccination 21.Extension Part: Percentage of Participants with Solicited and Unsolicited SAEs until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 22.Extension Part: Percentage of Participants with AESIs until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 23.Extension Part: Percentage of Participants with MAAEs until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 24.Extension Part: Percentage of Participants with any AEs Leading to Participant's Withdrawal from the Trial until Extension Part Day 29 Time Frame: Extension Part: Up to Day 29 25.Extension Part: Percentage of Participants with SARS-CoV-2 Infection until Extension Part Day 29. Time Frame: Extension Part: Up to Day 29 26.Extension Part: Percentage of Participants with Solicited and Unsolicited SAEs throughout the Extension Part of the Trial Time Frame: Extension Part: Up to Day 366 27.Extension Part: Percentage of Participants with AESIs throughout the Extension Part of the Trial Time Frame: Extension Part: Up to Day 366 28.Extension Part: Percentage of Participants with MAAEs throughout the Extension Part of the Trial Time Frame: Extension Part: Up to Day 366 29.Extension Part: Percentage of Participants with any AEs Leading to Participant's Withdrawal from the Trial from the Day of the Second Single Booster Vaccination throughout the Extension Part of the Trial Time Frame: Extension Part: From Day 1 to Day 366 30.Extension Part: Percentage of Participants with SARS-CoV-2 infection throughout the Extension Part of Trial Time Frame: Extension Part: Up to Day 366

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	MAIN PART: 1.Healthy Japanese male and female adult participants aged >= 20 years of age at the time of signing of informed consent. 2.Participant who completed 2 doses primary vaccinations with another specified mRNA vaccine (SARS-CoV-2) which is available in Japan 6 to 12 months prior to the trial vaccination. EXTENSION PART: 3.Participants who received the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).
Exclude criteria	MAIN PART: 1.Participants who received any other SARS-CoV-2 vaccine (except for the specified mRNA vaccine) or other experimental novel coronavirus vaccine prior to the trial. 2.Participant who received a booster vaccination (i.e. 3rd dose) 3.Participants who have close contact of anyone known to have COVID-19 within 14 days prior to the trial vaccination. 4.Participants who were tested positive for SARS-CoV-2 prior to the trial. 5.Participants who have traveled outside of Japan in the 30 days prior to the trial participation. 6.Participants with a clinically significant active infection or oral temperature >= 38 degree Celsius within 3 days of the intended date of the first single booster vaccination. 7.Participants with body mass index (BMI) greater than or equal to 30 kg/m^2 (BMI= weight in kg/ height in meters^2). EXTENSION PART: 8.Participants with a clinically significant active infection or oral temperature >=38 degree Celsius within 3 days of the intended date of the second single booster vaccination.

Related Information

Primary Sponsor	Kuriyama Kenji
Secondary Sponsor
Source(s) of Monetary Support	Ministry of Health, Labour and Welfare
Secondary ID(s)	NCT05299359

Contact

Public contact
Name	Trial Information Contact for Clinical
Address	1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone	+81-6-6204-2111
E-mail	smb.Japanclinicalstudydisclosure@takeda.com
Affiliation	Takeda Pharmaceutical Company Limited
Scientific contact
Name	Kenji Kuriyama
Address	1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone	+81-6-6204-2111
E-mail	smb.Japanclinicalstudydisclosure@takeda.com
Affiliation	Takeda Pharmaceutical Company Limited

TO Original Data: JRCT