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

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NCT00562354

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Study Location
Fukuoka-shi, Fukuoka, 812-0025, Japan
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Contact
1-800-718-1021
[email protected]
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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Biological: 13vPnC
13vPnC for both stratum
Study Arms  ICMJE
  • Experimental: 1
    Stratum 1: >= 65 years of age
    Intervention: Biological: 13vPnC
  • Experimental: 2
    Stratum 2: 50 to 64 years of age
    Intervention: Biological: 13vPnC
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2011)		271
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2007)		270
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT00562354
Other Study ID Numbers  ICMJE 6115A1-3004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP