A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
NCT ID: NCT03571607
Last Updated: 2020-02-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
206 participants
INTERVENTIONAL
2018-07-12
2018-11-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
NCT00562354
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
NCT04530838
A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older
NCT01646398
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
NCT00574795
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
NCT04875533
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
13-valent pneumococcal conjugate vaccine
A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects with an increased risk of pneumococcal disease determined by documented medical history, physical examination, and clinical judgment of the investigator.
Exclusion Criteria
* 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.
6 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Daido Clinic
Nagoya, Aichi-ken, Japan
Nippon Kokan Fukuyama Hospital
Fukuyama, Hiroshima, Japan
Fukuyama City Hospital
Fukuyama, Hiroshima, Japan
Kawasaki Municipal Hospital
Kawasaki, Kanagawa, Japan
Nagano Prefectural Shinshu Medical Center
Suzaka, Nagano, Japan
Medical Co.LTA PS Clinic
Fukuoka, , Japan
Fukuoka Children's Hospital
Fukuoka, , Japan
National Hospital Organization Kumamoto Medical Center
Kumamoto, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Yamazaki Y, Ikeda M, Imada T, Furuno K, Mizukami T, de Solom R, Shoji Y, Oe M, Aizawa M, Giardina PC, Schmoele-Thoma B, Scott DA. 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 participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines. Vaccine. 2021 Oct 15;39(43):6414-6421. doi: 10.1016/j.vaccine.2021.08.106. Epub 2021 Sep 23.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-003054-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1851172
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.