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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

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NCT00562354

Last updated on December 5, 2018
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FOR MORE INFORMATION
Study Location
Fukuoka-shi, Fukuoka, 812-0025 Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Japanese descent male and female adults who do not have the potential to bear children
>= 50 years of age.

- Determined to be eligible for the study based on medical history, physical
examination, and clinical judgment. Subjects with preexisting stable disease, defined
as disease not requiring significant change in therapy or hospitalization for
worsening disease 12 weeks before receipt of study vaccine, are eligible.

- Sexually active men must agree and commit to use a medically accepted form of
contraception during the study and for at least 3 months after vaccination.

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

- History of severe adverse reaction associated with a vaccine.

- Receipt of any vaccine within 30 days before study vaccination, except influenza
vaccine.

- Documented S pneumoniae infection within the past 5 years before study vaccination.

NCT00562354
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

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[email protected]

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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
A Phase 3, Open-Label Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a 13vPnC When Administered to Healthy Japanese Adults Aged >= 65 Years and 50 to 64 Years in Japan Who Have Not Received a Previous Dose of 23-Valent Pneumococcal Polysaccharide Vaccine
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50 years.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Healthy
Biological: 13vPnC
13vPnC for both stratum
  • Experimental: 1
    Stratum 1: >= 65 years of age
    Intervention: Biological: 13vPnC
  • Experimental: 2
    Stratum 2: 50 to 64 years of age
    Intervention: Biological: 13vPnC
Shiramoto M, Irie S, Juergens C, Yamaji M, Tamai S, Aizawa M, Belanger T, Gruber WC, Scott DA, Schmoele-Thoma B. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine when administered to healthy Japanese adults aged ?50 years. An open-label trial. Hum Vaccin Immunother. 2014;10(7):1850-8. doi: 10.4161/hv.28633.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
271
December 2007
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Japanese descent male and female adults who do not have the potential to bear children >= 50 years of age.
  • Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
  • Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.

Exclusion Criteria:

  • History of severe adverse reaction associated with a vaccine.
  • Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
  • Documented S pneumoniae infection within the past 5 years before study vaccination.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00562354
6115A1-3004
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
October 2011

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

BY EMAIL

Contact

[email protected]



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