NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071200094

Registered date:29/01/2021

Phase 1 Study of a pPCV in Healthy Japanese Adults

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPneumococcal infection prevention
Date of first enrollment04/02/2021
Target sample size100
Countries of recruitment
Study typeInterventional
Intervention(s)pPCV (1.0 mL) or PPSV23 (0.5 mL) will be administered as a single IM injection.

Outcome(s)

Primary OutcomeSolicited AEs and vaccine related SAEs
Secondary OutcomeSerotype-specific OPA and IgG responses

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
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

Contact

Public contact
Name MSDJRCT inquiry mailbox
Address KITANOMARU SQUARE, 1-13-12, Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.
Scientific contact
Name Yoshiyuki Tanaka
Address KITANOMARU SQUARE, 1-13-12,Kudan-kita,Chiyoda-ku,Tokyo 102-8667,Japan Tokyo Japan 102-8667
Telephone +81-3-6272-1957
E-mail msdjrct@merck.com
Affiliation MSD K.K.