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

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NCT00574548

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Chandler, Arizona, 85224 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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.

NCT00574548
Pfizer
Completed
Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS

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Study Evaluating the Safety, Tolerability and Immunogenicity of 13vPnC as a 2-Dose Regimen or With 23vPS
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Pneumococcal Vaccines
  • 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
  • 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
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.
 
Completed
720
February 2010
February 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
60 Years to 64 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00574548
6115A1-3010
B1851027
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
July 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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