Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:39 PM
Ignite Modification Date:
2025-12-24 @ 2:39 PM
NCT ID:
NCT05299359
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the first trial vaccination at least 5 months earlier and are currently enrolled in the Main Part (ie, not have withdrawn or discontinued early).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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05299359
Study Brief:
Protocol Section:
NCT05299359