Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

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NCT00574548

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Study Location
Pfizer Investigational Site
Chandler, Arizona, 85224, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or Female, aged 60 to 64 years.

- Healthy.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous vaccination with any licensed or experimental pneumococcal vaccine.


- History of severe adverse reaction associated with a vaccine.


- Immunodeficiency.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
Official Title  ICMJE A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-Dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naive to 23vPS
Brief Summary The objective of this study is to compare the safety, tolerability and immunologic response to a dose of 23vPS or 13vPnC given one year after either 13vPnC or 23vPS in subjects that have never received a previous dose of 23vPS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccines
Intervention  ICMJE
  • Biological: 13 valent Pneumococcal Conjugate Vaccine
    0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and year 1
  • Biological: 13 valent Pneumococcal Conjugate Vaccine
    0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
  • Biological: 13 valent Pneumococcal Conjugate Vaccine
    0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine
    0.5 ml dose 23vPS will be administered into the deltoid muscle at year 0 and 0.5 ml dose 13vPnC at year 1
  • Biological: 23-valent Pneumococcal Polysaccharide Vaccine
    0.5 ml dose 13vPnC will be administered into the deltoid muscle at year 0 and 0.5 ml dose 23vPS at year 1
Study Arms  ICMJE
  • Experimental: Group 1.1
    Group 1.1 = 13vPnC then 13vPnC
    Intervention: Biological: 13 valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 1.2
    Group 1.2 = 13vPnC then 23vPS
    Interventions:
    • Biological: 13 valent Pneumococcal Conjugate Vaccine
    • Biological: 23-valent Pneumococcal Polysaccharide Vaccine
  • Experimental: Group 2
    Group 2 = 23vPS then 13vPnC
    Interventions:
    • Biological: 13 valent Pneumococcal Conjugate Vaccine
    • Biological: 23-valent Pneumococcal Polysaccharide Vaccine
Publications * Greenberg RN, Gurtman A, Frenck RW, Strout C, Jansen KU, Trammel J, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naïve adults 60-64 years of age. Vaccine. 2014 Apr 25;32(20):2364-74. doi: 10.1016/j.vaccine.2014.02.002. Epub 2014 Mar 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2007)		720
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or Female, aged 60 to 64 years.
  • Healthy.

Exclusion Criteria:

  • Previous vaccination with any licensed or experimental pneumococcal vaccine.
  • History of severe adverse reaction associated with a vaccine.
  • Immunodeficiency.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574548
Other Study ID Numbers  ICMJE 6115A1-3010
B1851027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP