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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00500266
First received: July 9, 2007
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Pneumococcal Infections
 Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Pre-specified Local Reactions [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants With Pre-specified Systemic Events [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]
    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.

  • Percentage of Participants Taking Pain or Antipyretic Medication [ Time Frame: Days 1 through 14 ] [ Designated as safety issue: Yes ]
    Use of pain or antipyretic medication was collected by the participants using an electronic diary.


Enrollment: 1053
Study Start Date: May 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
13-valent Pneumococcal Conjugate Vaccine
 Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

  Eligibility

Ages Eligible for Study:   68 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500266

  Show 59 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00500266     History of Changes
Other Study ID Numbers: 6115A1-3000
Study First Received: July 9, 2007
Results First Received: August 11, 2011
Last Updated: August 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
pneumococcal conjugate vaccine
vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on June 18, 2013