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 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT04665050
Eligibility Criteria:
Inclusion Criteria:
* is a healthy Japanese male or female ≥20 years of age at time of randomization
* male participants must agree to be abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
* female participants must not be pregnant or breastfeeding, and is either:
* not a woman of childbearing potential (WOCBP) or
* a WOCBP who agrees to remain abstinent or use contraception during the intervention period and for ≥30 days after the last dose of study intervention
Exclusion Criteria:
* has a history of invasive pneumococcal disease (IPD) within 3 years of Day 1
* has a known hypersensitivity to any vaccine components
* has impaired immunological function
* has a coagulation disorder
* had a recent febrile illness (axillary temperature ≥37.5°C or equivalent) within 72 hours before Day 1
* has a known malignancy that is progressing/requiring treatment
* has received, or is expected to receive, a pneumococcal vaccine outside the study protocol
* has received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed the regimen for ≥30 days prior to Day 1
* is receiving immunosuppressive therapy
* has received any non-live vaccine from 14 days prior to Day 1 other than inactivated influenza vaccine
* has received any live vaccine from 30 days prior to Day 1
* has received a blood transfusion or blood products
* has participated in another clinical trial within 2 months of this study
* has clinically relevant drug or alcohol abuse
* has any condition that, in the opinion of the investigator, precludes participation in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT04665050
Study Brief:
Protocol Section:
NCT04665050