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Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Chandler, Arizona, 85224 United States
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
68+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female aged 68 years or older

- Determined by medical history, physical examination, and clinical judgment to be
eligible for the study

- Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years
before study enrollment

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

- Known history of severe reaction to a vaccine

- Documented S pneumoniae infection within the past 5 years.

- Known or suspected immunodeficiency or receiving treatment with immunosuppressive
therapy including cytotoxic agents or systemic corticosteroids

- Serious chronic disorder including metastatic malignancy, severe chronic obstructive
pulmonary disease requiring supplemental oxygen, end-stage renal disease with or
without dialysis, clinically unstable cardiac disease, or any other disorder that in
the investigator's opinion precludes the subject from participating in the study.

NCT00500266
Pfizer
Completed
Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

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Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects
A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, & Reactogenicity of a 13vPnC Vaccine in Ambulatory Elderly Adults Aged 68 Years & Older Who Received 1 or More Doses of 23vPS Vaccine at Least 3 Years Before Study Enrollment
To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.
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 (13vPnC)
Experimental: 1
13-valent Pneumococcal Conjugate Vaccine
Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1053
May 2009
April 2009   (Final data collection date for primary outcome measure)

MAIN INCLUSION CRITERIA:

  • Male or female aged 68 years or older
  • Determined by medical history, physical examination, and clinical judgment to be eligible for the study
  • Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment

MAIN EXCLUSION CRITERIA:

  • Known history of severe reaction to a vaccine
  • Documented S pneumoniae infection within the past 5 years.
  • Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
  • Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.
Sexes Eligible for Study: All
68 Years and older   (Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany,   Sweden,   United States
 
 
NCT00500266
6115A1-3000
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
August 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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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