JRCT ID: jRCT2071200094
Registered date:29/01/2021
Phase 1 Study of a pPCV in Healthy Japanese Adults
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | Pneumococcal infection prevention |
Date of first enrollment | 04/02/2021 |
Target sample size | 100 |
Countries of recruitment | |
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 |
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Secondary Outcome | Serotype-specific OPA and IgG responses |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT04665050 |
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 |
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 |
msdjrct@merck.com | |
Affiliation | MSD K.K. |