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A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Nagano Prefectural Shinshu Medical Center
Suzaka, Nagano, 382-8577 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese males and females aged 6 to

- Subjects with an increased risk of pneumococcal disease determined by documented
medical history, physical examination, and clinical judgment of the investigator.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03571607
Pfizer
Not yet recruiting
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.

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A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
A Phase 3, Multicenter, Single-Arm, Open-Label Study to Assess Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Subjects Aged 6 To 64 Years Who Are at Increased Risk of Pneumococcal Disease
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Infections
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
Experimental: 13-valent pneumococcal conjugate vaccine
Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
Same as current
November 19, 2018
November 19, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
6 Years to 64 Years   (Child, Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03571607
B1851172
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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