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

NCT00500266 | Completed Phase 3 Results

• 1 other identifier: 6115A1-3000
• Study Type: interventional
• Target: 1,053
• Locations: 3 countries
• Sites: 59

Brief Summary

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.

Conditions

Pneumococcal Infections

Keywords

pneumococcal conjugate vaccine; vaccine

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Pre-specified Local Reactions

  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

  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

  Use of pain or antipyretic medication was collected by the participants using an electronic diary.

  Days 1 through 14

Study Arms (1)

1

EXPERIMENTAL

13-valent Pneumococcal Conjugate Vaccine

Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Interventions

13-valent Pneumococcal Conjugate Vaccine (13vPnC) BIOLOGICAL

1

Eligibility Criteria

• Age: 68 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

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Chandler, Arizona, 85224, United States

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Glendale, Arizona, 85308, United States

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Phoenix, Arizona, 85028, United States

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Phoenix, Arizona, 85104, United States

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Rolling Hills Estates, California, 90274, United States

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Apopka, Florida, 32703, United States

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Boynton Beach, Florida, 33472, United States

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Chiefland, Florida, 32626, United States

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Gainesville, Florida, 32607, United States

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Largo, Florida, 33770, United States

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Melbourne, Florida, 32935, United States

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West Palm Beach, Florida, 33409, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30342, United States

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Arkansas City, Kansas, 67005, United States

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Newton, Kansas, 67114, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Crescent Springs, Kentucky, 41017, United States

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New Orleans, Louisiana, 70112, United States

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Nitchitoches, Louisiana, 71547, United States

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Camillus, New York, 13031, United States

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Rochester, New York, 14609, United States

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Raleigh, North Carolina, 27609, United States

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Akron, Ohio, 44304, United States

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Canal Fulton, Ohio, 44614, United States

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Columbus, Ohio, 43235, United States

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Franklin, Ohio, 45005, United States

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Portland, Oregon, 97205, United States

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Pittsburgh, Pennsylvania, 15216, United States

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Goose Creek, South Carolina, 29445, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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West Jordan, Utah, 84088, United States

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Bellingham, Virginia, 98226, United States

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Walla Walla, Washington, 99362, United States

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Wenatchee, Washington, 98801, United States

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Berlin, 10717, Germany

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Berlin, 10969, Germany

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Berlin-Wilmersdorf, 10717, Germany

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Charlottenburg, 14059, Germany

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Deggingen, 73326, Germany

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Frankfurt am Main, 60322, Germany

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Hanover, 30625, Germany

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Kassel, 34121, Germany

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Leipzig, 04357, Germany

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Offenbach, 63071, Germany

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Wangen, 88239, Germany

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Würzburg, 97070, Germany

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Arlöv, 23234, Sweden

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Gothenburg, 41136, Sweden

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Skene, 51162, Sweden

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Skivarp, 27402, Sweden

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Stockholm, 11136, Sweden

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Umeå, 90736, Sweden

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Uppsala, 75185, Sweden

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MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 9, 2007
• First Posted: July 11, 2007
• Study Start: May 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 16, 2011
• Results First Posted: September 16, 2011

Record last verified: 2011-08

Locations

US (40); DE (12); SE (7)