Phase 1 Study of a pPCV in Healthy Japanese Adults

JRCT ID: jRCT2071200094

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pneumococcal infection prevention
• Date of first enrollment: 04/02/2021
• Target sample size: 100
• Study type: Interventional
• Intervention(s): pPCV (1.0 mL) or PPSV23 (0.5 mL) will be administered as a single IM injection.

Outcome(s)

• Primary Outcome: Solicited AEs and vaccine related SAEs
• Secondary Outcome: Serotype-specific OPA and IgG responses

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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 study and for >=30 days after completing the study
- 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 study and for >=30 days after completing the study

Exclude 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 >=37.5C 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

Related Information

• Primary Sponsor: Tanaka Yoshiyuki
• Secondary ID(s): NCT04665050