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

October 18, 2024 updated by: Takeda

A Phase 3, Single Arm, Open-Label Trial to Evaluate the Immunogenicity and Safety of a Single Heterologous Booster Vaccination of TAK-019 in Healthy Japanese Male and Female Adults Aged 20 Years and Older (COVID-19)

TAK-019 is a vaccine in development to protect people against Covid-19. The main aims of the study are to learn if TAK-019 can protect people from Covid-19 and to check for side effects from TAK-019 for participants who will receive TAK-019 as heterologous booster vaccination.

This study consists of two parts, main part and extension part. Firstly, participants who completed 2 doses primary vaccinations 6 to 12 months prior to the trial vaccination can take part in main study. At the first visit of main part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as booster vaccination.

Participants will be asked to record their temperature and any medical problems in an electronic diary for up to 7 days after the injection. During the main part, participants will visit the clinic for regular check-ups, blood tests, and sometimes for nose swab samples. When all participants have attended a clinic visit 28 days after the injection, the study sponsor (Takeda) will check how many participants have made enough antibodies to protect them against Covid-19.

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 be able to decide to take part in the extension part of this study. At the first visit of extension part of this study, the study doctor will check if each person can take part. Participants who can take part will receive an injection of TAK-019 as a second booster vaccination at the first visit of extension part.

The participants will stay in the main part of this study for up to 12 months after they have had their injection or up to the start of extension part. For participants who will take part in the extension part, they will stay in the extension part for up to 12 months from the start of extension part. During this time, the doctors will continue to collect blood samples to check immune response. Also, they will check if participants have any more side effects from TAK-019.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • PS Clinic
    • Tokyo
      • Sumida-ku, Tokyo, Japan
        • Sumida Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion 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 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).

Exclusion 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TAK-019 Main Part
TAK-019 0.5 mL, intramuscular injection in the mid deltoid, preferable in the non-dominant upper arm
Biological: TAK-019
TAK-019 intramuscular injection
Experimental: TAK-019 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.
Biological: TAK-019
TAK-019 intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 for this study (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.
Day 15 for this study (14 days after the vaccination); Day 36 for TAK-019-1501 study (14 days after the second vaccination)
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.
Main Part: 7 days after the first single booster vaccination
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.
Main Part: 7 days after the first single booster vaccination
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.
Main Part: 28 days after the first single booster vaccination
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.
Main Part: Up to Day 29
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 included 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.
Main Part: Up to Day 29
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.
Main Part: Up to Day 29
Main Part: Percentage of Participants With Any AE Leading to 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.
Main Part: Up to Day 29
Main Part: Percentage of Participants With Severe Acute Respiratory Syndrome Coronavirus-2 (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.
Main Part: Up to Day 29

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Main Part: Day 8, 15, 29, 91, 181, and 366
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 titer level. Where baseline was defined as the last measurement taken before the first dose of trial vaccination.
Main Part: Day 8, 15, 29, 91, 181, and 366
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 as percentage of participants with 4-fold or more rises from baseline in titer. Baseline was defined as the last measurement taken before the first dose of trial vaccination.
Main Part: Day 8, 15, 29, 91, 181, and 366
Main Part: GMT of Serum Neutralizing Antibody Titers 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 percent (%) of the replicate wells were protected from infection (microneutralization [MN] with an inhibitory concentration of 50% [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.
Main Part: Day 8, 15, 29, 91, 181, and 366
Main Part: GMFR of Serum Neutralizing Antibody Titers 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.
Main Part: Day 8, 15, 29, 91, 181, and 366
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 as percentage of participants with 4-fold or more rises in from baseline. Baseline was defined as the last measurement taken before the first dose of trial vaccination.
Main Part: Day 8, 15, 29, 91, 181, and 366
Main Part: Percentage of Participants With Solicited and Unsolicited SAEs Throughout the Main Part of Trial
Time Frame: Main Part: Up to Day 366
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.
Main Part: Up to Day 366
Main Part: Percentage of Participants With AESI Throughout the Main Part of Trial
Time Frame: Main Part: Up to Day 366
An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the 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.
Main Part: Up to Day 366
Main Part: Percentage of Participants With MAAEs Throughout the Main Part of Trial
Time Frame: Main Part: Up to Day 366
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.
Main Part: Up to Day 366
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: Day 1 up to Day 366
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 was reported.
Main Part: Day 1 up to Day 366
Main Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Main Part of Trial
Time Frame: Main Part: Day 1 up to Day 366
Percentage of participants with SARS-CoV-2 infection throughout the main part of trial was reported.
Main Part: Day 1 up to Day 366
Extension Part: GMT of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Day 15, 29, 91, 181, and 366
Time Frame: Extension Part: Day 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.
Extension Part: Day 15, 29, 91, 181, and 366
Extension Part: GMFR of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366
Time Frame: Extension Part: Day 15, 29, 91, 181, and 366
The GMFR was calculated as the ratio of the post-second-booster-vaccination titer level to extension part baseline titer level. Where extension part baseline was defined as last measurement taken before the second booster vaccination.
Extension Part: Day 15, 29, 91, 181, and 366
Extension Part: Seroconversion Rate (SCR) of Serum IgG Antibody Levels to SARS-CoV-2 rS Protein on Extension Part Day 15, 29, 91, 181, and 366
Time Frame: Extension Part: Day 15, 29, 91, 181, and 366
SCR was defined as percentage of participants with 4-fold or more rises in titer from extension part baseline. Where extension part baseline was defined as last measurement taken before the second booster vaccination.
Extension Part: Day 15, 29, 91, 181, and 366
Extension Part: GMT of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366
Time Frame: Extension Part: Day 15, 29, 91, 181, and 366
The neutralization titer was expressed as the reciprocal of the highest dilution at >= 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.
Extension Part: Day 15, 29, 91, 181, and 366
Extension Part: GMFR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366
Time Frame: Extension Part: Day 15, 29, 91, 181, and 366
The neutralization titer was expressed as the reciprocal of the highest dilution at >= 50% of the replicate wells were protected from infection (MN50). The GMFR was calculated as the ratio of the post-second-booster-vaccination titer level to extension part baseline titer level. Where extension part baseline was defined as last measurement taken before the second booster vaccination.
Extension Part: Day 15, 29, 91, 181, and 366
Extension Part: SCR of Serum Neutralizing Antibody Titers to the Ancestral Strain (Wild-type Virus) on Extension Part Day 15, 29, 91, 181, and 366
Time Frame: Extension Part: Day 15, 29, 91, 181, and 366
The neutralization titer was expressed as the reciprocal of the highest dilution at >= 50% of the replicate wells were protected from infection (MN50). SCR was defined as percentage of participants with 4-fold or more rises in titer from extension part baseline.
Extension Part: Day 15, 29, 91, 181, and 366
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
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.
Extension Part: 7 days after the second single booster vaccination
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
Solicited systemic AEs included were defined as fever, fatigue, malaise, myalgia, arthralgia, nausea/vomiting and headache.
Extension Part: 7 days after the second single booster vaccination
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
Unsolicited AEs defined as AEs other than solicited local AEs and solicited systemic AEs.
Extension Part: 28 days after the second single booster vaccination
Extension Part: Percentage of Participants With Solicited and Unsolicited SAEs Until Extension Part Day 29
Time Frame: Extension 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.
Extension Part: Up to Day 29
Extension Part: Percentage of Participants With AESIs Until Extension Part Day 29
Time Frame: Extension Part: Up to Day 29
An AESI was defined as AEs that will be specifically highlighted to the investigator. AESIs for the study included the 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.
Extension Part: Up to Day 29
Extension Part: Percentage of Participants With MAAEs Until Extension Part Day 29
Time Frame: Extension 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.
Extension Part: Up to Day 29
Extension Part: Percentage of Participants With Any AEs Leading to Withdrawal From the Trial Until Extension Part Day 29
Time Frame: Extension Part: Up to Day 29
Percentage of participants with any AEs leading to withdrawal from the trial until extension part Day 29 was reported.
Extension Part: Up to Day 29
Extension Part: Percentage of Participants With SARS-CoV-2 Infection Until Extension Part Day 29
Time Frame: Extension Part: Up to Day 29
Percentage of participants with SARS-CoV-2 infection until extension part Day 29 was reported.
Extension Part: Up to Day 29
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
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.
Extension Part: Up to Day 366
Extension Part: Percentage of Participants With AESIs Throughout the Extension Part of the Trial
Time Frame: Extension Part: Up to Day 366
An AESI was defined as AEs that will be specifically highlighted to the Investigator. AESIs for the study included the 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.
Extension Part: Up to Day 366
Extension Part: Percentage of Participants With MAAEs Throughout the Extension Part of the Trial
Time Frame: Extension Part: Up to Day 366
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.
Extension Part: Up to Day 366
Extension Part: Percentage of Participants With Any AEs Leading to 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 up to Day 366
Percentage of participants with any AEs leading to withdrawal from the trial from the day of the second single booster vaccination throughout the extension part of the trial was reported.
Extension Part: From Day 1 up to Day 366
Extension Part: Percentage of Participants With SARS-CoV-2 Infection Throughout the Extension Part of Trial
Time Frame: Extension Part: Up to Day 366
Percentage of participants with SARS-CoV-2 infection throughout the extension part of trial was reported.
Extension Part: Up to Day 366

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-019-3001
  • jRCT2071210141 (Registry Identifier: jRCT)
  • U1111-1281-3948 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

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