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

August 11, 2011 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1053

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10969
      • Berlin, Germany, 10717
      • Berlin-Charlottenburg, Germany, 14059
      • Berlin-Wilmersdorf, Germany, 10717
      • Deggingen, Germany, 73326
      • Frankfurt-am-Main, Germany, 60322
      • Hannover, Germany, 30625
      • Kassel, Germany, 34121
      • Leipzig, Germany, 04357
      • Offenbach, Germany, 63071
      • Wangen, Germany, 88239
      • Wuerzburg, Germany, 97070
  • Sweden
      • Arlov, Sweden, 23234
      • Gothenburg, Sweden, 41136
      • Skene, Sweden, 51162
      • Skivarp, Sweden, 27402
      • Stockholm, Sweden, 11136
      • Umea, Sweden, 90736
      • Uppsala, Sweden, 75185
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Glendale, Arizona, United States, 85308
      • Phoenix, Arizona, United States, 85028
      • Phoenix, Arizona, United States, 85104
    • California
      • Rolling Hills Estates, California, United States, 90274
    • Florida
      • Apopka, Florida, United States, 32703
      • Boynton Beach, Florida, United States, 33472
      • Chiefland, Florida, United States, 32626
      • Gainesville, Florida, United States, 32607
      • Largo, Florida, United States, 33770
      • Melbourne, Florida, United States, 32935
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30308
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Newton, Kansas, United States, 67114
      • Wichita, Kansas, United States, 67207
      • Wichita, Kansas, United States, 67205
    • Kentucky
      • Crescent Springs, Kentucky, United States, 41017
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
      • Nitchitoches, Louisiana, United States, 71547
    • New York
      • Camillus, New York, United States, 13031
      • Rochester, New York, United States, 14609
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
    • Ohio
      • Akron, Ohio, United States, 44304
      • Canal Fulton, Ohio, United States, 44614
      • Columbus, Ohio, United States, 43235
      • Franklin, Ohio, United States, 45005
    • Oregon
      • Portland, Oregon, United States, 97205
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15216
    • South Carolina
      • Goose Creek, South Carolina, United States, 29445
      • Mt Pleasant, South Carolina, United States, 29464
    • Texas
      • Houston, Texas, United States, 77074
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • West Jordan, Utah, United States, 84088
    • Virginia
      • Bellingham, Virginia, United States, 98226
    • Washington
      • Walla Walla, Washington, United States, 99362
      • Wenatchee, Washington, United States, 98801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

68 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
13-valent Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Pre-specified Local Reactions
Time Frame: Days 1 through 14
Local reactions were collected by the participant using an electronic diary. Redness and swelling scaled as any(present); mild(2.5-5.0 centimeters[cm]); moderate(5.1-10.0 cm); severe(>10.0cm). Pain as any(present); mild(present, no interference with activity); moderate(present, some interference with activity); severe(present, prevents daily activity). Limitation of arm movement as any(present); mild(present, could move arm above head); moderate(could move arm above shoulder but not above head); severe(could not move arm above shoulder). Participants may be represented in more than 1 category.
Days 1 through 14
Percentage of Participants With Pre-specified Systemic Events
Time Frame: Days 1 through 14
Systemic events were collected by participant using electronic diary. Fatigue,headache,new/aggravated generalized muscle pain,new/aggravated generalized joint pain: any, mild(no interference with activity), moderate(some interference with activity), severe(prevents routine daily activity). Fever(>=38 degrees Celsius[C]), chills, rash, vomiting(mild:1-2 times daily; moderate:>2 times daily; severe:prevents daily activity) decreased appetite & diarrhea(mild:2-3 loose stools/day; moderate:4-5 loose stools/day; severe:>=6 loose stools/day) reported. Participants may be represented in >1 category.
Days 1 through 14
Percentage of Participants Taking Pain or Antipyretic Medication
Time Frame: Days 1 through 14
Use of pain or antipyretic medication was collected by the participants using an electronic diary.
Days 1 through 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 9, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (Estimate)

July 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 16, 2011

Last Update Submitted That Met QC Criteria

August 11, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6115A1-3000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe