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

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ClinicalTrials.gov Identifier: NCT00500266
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : September 16, 2011
Last Update Posted : September 16, 2011
Sponsor:
Information provided by:
Pfizer

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1053 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   68 Years and older   (Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500266


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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00500266     History of Changes
Other Study ID Numbers: 6115A1-3000
First Posted: July 11, 2007    Key Record Dates
Results First Posted: September 16, 2011
Last Update Posted: September 16, 2011
Last Verified: August 2011

Keywords provided by Pfizer:
pneumococcal conjugate vaccine
vaccine

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs