A Single Heterologous Booster Vaccination Study of TAK-019 in Healthy Japanese Adults (COVID-19)
Condition: Coronavirus Disease (COVID-19)
MeSH terms: COVID-19
Intervention: TAK-019
Intervention description: TAK-019 intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.