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

NCT ID: NCT00500266

Last Updated: 2011-09-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1053 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

13-valent Pneumococcal Conjugate Vaccine

Group Type EXPERIMENTAL

13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Intervention Type BIOLOGICAL

Interventions

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13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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.
Minimum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Chandler, Arizona, United States

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Glendale, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Rolling Hills Estates, California, United States

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Apopka, Florida, United States

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Boynton Beach, Florida, United States

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Chiefland, Florida, United States

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Gainesville, Florida, United States

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Largo, Florida, United States

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Melbourne, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Arkansas City, Kansas, United States

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Newton, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Crescent Springs, Kentucky, United States

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New Orleans, Louisiana, United States

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Nitchitoches, Louisiana, United States

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Camillus, New York, United States

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Rochester, New York, United States

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Raleigh, North Carolina, United States

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Akron, Ohio, United States

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Canal Fulton, Ohio, United States

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Columbus, Ohio, United States

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Franklin, Ohio, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Goose Creek, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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West Jordan, Utah, United States

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Bellingham, Virginia, United States

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Walla Walla, Washington, United States

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Wenatchee, Washington, United States

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Berlin, , Germany

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Berlin, , Germany

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Berlin-Wilmersdorf, , Germany

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Charlottenburg, , Germany

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Deggingen, , Germany

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Frankfurt am Main, , Germany

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Hanover, , Germany

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Kassel, , Germany

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Leipzig, , Germany

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Offenbach, , Germany

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Wangen, , Germany

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Würzburg, , Germany

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Arlöv, , Sweden

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Gothenburg, , Sweden

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Skene, , Sweden

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Skivarp, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Countries

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United States Germany Sweden

Other Identifiers

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6115A1-3000

Identifier Type: -

Identifier Source: org_study_id

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