A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
NCT03571607
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Adult Trials: 18+ Years
- Japanese males and females aged 6 to <65 years at enrollment.
- Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt during study participation.
- End-stage disease including but not limited to metastatic malignancy, severe chronic
obstructive pulmonary disease (COPD) requiring supplemental oxygen, or end-stage renal
disease with or without dialysis.
- Graft-versus-host disease (GVHD), history of solid organ transplant within 6 months
before investigational product administration or history of HSCT, or potential for
solid organ transplant or HSCT during study participation.
- Receipt of cytotoxic chemotherapy or blood products within 3 months before
investigational product administration or anti-B-cell antibodies within 6 months
before investigational product administration through completion of study
participation.
- Any contraindication to vaccination or vaccine components, including previous
anaphylactic reaction to any vaccine or vaccine-related components.
- Documented S pneumoniae infection within the past 5 years before investigational
product administration.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years. | ||||||
| Official Title ICMJE | A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SINGLE DOSE OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN JAPANESE SUBJECTS AGED 6 TO 64 YEARS WHO ARE CONSIDERED TO BE AT INCREASED RISK OF PNEUMOCOCCAL DISEASE AND WHO ARE NAIVE TO PNEUMOCOCCAL VACCINES | ||||||
| Brief Summary | This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Prevention | ||||||
| Condition ICMJE | Pneumococcal Infections | ||||||
| Intervention ICMJE | Biological: 13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1. Other Name: 13vPnC | ||||||
| Study Arms ICMJE | Experimental: 13-valent pneumococcal conjugate vaccine
Intervention: Biological: 13-valent pneumococcal conjugate vaccine | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 206 | ||||||
| Original Estimated Enrollment ICMJE | 200 | ||||||
| Actual Study Completion Date ICMJE | November 16, 2018 | ||||||
| Actual Primary Completion Date | November 16, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 6 Years to 64 Years (Child, Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Japan | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03571607 | ||||||
| Other Study ID Numbers ICMJE | B1851172 2018-003054-24 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||