Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults

NCT00744263

Last updated date
Study Location
Pfizer Investigational Site
Tilburg, Noord Brabant, 5022 JB, Netherlands
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Pneumonia, Pneumococcal Infections, 13-valent Pneumococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.

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


- Residence in a nursing home, long-term care facility, or similar facility


- Known hypersensitivity to vaccination


- Immune deficiency or suppression

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Pneumococcal Pneumonia, Pneumococcal Infections, 13-valent Pneumococcal VaccineStudy Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
NCT00744263
  1. Tilburg, Noord Brabant
  2. Abbekerk,
  3. Alkmaar,
  4. Alkmaar,
  5. Almelo,
  6. Almere,
  7. Almere,
  8. Alphen aan de Rijn,
  9. Amersfoort,
  10. Amersfoort,
  11. Amstelveen,
  12. Amstelveen,
  13. Amsterdam,
  14. Amsterdam,
  15. Amsterdam,
  16. Amsterdam,
  17. Amsterdam,
  18. Amsterdam,
  19. Amsterdam,
  20. Apeldoorn,
  21. Apeldoorn,
  22. Apeldoorn,
  23. Arnhem,
  24. Arnhem,
  25. Assen,
  26. Assen,
  27. Baarle-Nassau,
  28. Baarn,
  29. Bedum,
  30. Bennebroek,
  31. Bergen op Zoom,
  32. Bergen op Zoom,
  33. Berkel Enschot,
  34. Berkhout,
  35. Bilthoven,
  36. Blaricum,
  37. Breda,
  38. Breda,
  39. Breda,
  40. Brunssum,
  41. Deventer,
  42. Deventer,
  43. Dongen,
  44. Eelde,
  45. Eindhoven,
  46. Eindhoven,
  47. Eindhoven,
  48. Eindhoven,
  49. Eindhoven,
  50. Emmen,
  51. Emmen,
  52. Enschede,
  53. Enschede,
  54. Epe,
  55. Ettenleur,
  56. Fijnaart,
  57. Geldrop,
  58. Geldrop,
  59. Geldrop,
  60. Goirle,
  61. Gouda,
  62. Gouda,
  63. Groningen,
  64. Groningen,
  65. Groningen,
  66. Groningen,
  67. Grootebroek,
  68. Haarlem,
  69. Haarlem,
  70. Haren,
  71. Harmelen,
  72. Heerhugowaard,
  73. Heerlen,
  74. Heerlen,
  75. Heiloo,
  76. Helmond,
  77. Hengelo,
  78. Hengelo,
  79. Hilvarenbeek,
  80. Hilversum,
  81. Hilversum,
  82. Hoofddorp,
  83. Hoogezand,
  84. Hoorn,
  85. Hoorn,
  86. Hoorn,
  87. Houten,
  88. Kampen,
  89. Katwijk,
  90. Kerkrade,
  91. Leek,
  92. Leeuwarden,
  93. Leeuwarden,
  94. Leiden,
  95. Leiden,
  96. Leiden,
  97. Leiderdorp,
  98. Maarssen,
  99. Maastricht,
  100. Maastricht,
  101. Medemblik,
  102. Nieuwegein,
  103. Nieuwegein,
  104. Nijmegen,
  105. Nijmegen,
  106. Nijmegen,
  107. Noordwijk,
  108. Oldenzaal,
  109. Oosterhout,
  110. Peize,
  111. Rheden,
  112. Riel,
  113. Rijsbergen,
  114. Rijssen,
  115. Roden,
  116. Roermond,
  117. Roermond,
  118. Roermond,
  119. Roosendaal,
  120. Roosendaal,
  121. Schoorl,
  122. Simpelveld,
  123. Sittard,
  124. Sittard,
  125. Sleen,
  126. Soest,
  127. Son,
  128. Spaubeek,
  129. Steenbergen,
  130. Tiel,
  131. Tilburg,
  132. Tilburg,
  133. Tilburg,
  134. Uithoorn,
  135. Urmond,
  136. Utrecht,
  137. Utrecht,
  138. Utrecht,
  139. Utrecht,
  140. Utrecht,
  141. Utrecht,
  142. Veldhoven,
  143. Veldhoven,
  144. Veldhoven,
  145. Velp,
  146. Venlo,
  147. Venlo,
  148. Waalwijk,
  149. Warmenhuizen,
  150. Weert,
  151. Woerden,
  152. Zeist,
  153. Zeist,
  154. Zeist,
  155. Zevenaar,
  156. Zutphen,
  157. Zutphen,
  158. Zwolle,
  159. Zwolle,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults
Official Title  ICMJE A Phase 4, Randomized, Placebo-Controlled Clinical Trial of 13-valent Pneumococcal Conjugate Vaccine Efficacy in Prevention of Vaccine-Serotype Pneumococcal Community-Acquired Pneumonia and Invasive Pneumococcal Disease
Brief Summary The purpose of this study is to assess the efficacy of 13-valent pneumococcal conjugate vaccine in the prevention of the first episode of vaccine-type pneumococcal community-acquired pneumonia in adults.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumonia, Pneumococcal
  • Pneumococcal Infections
  • 13-valent Pneumococcal Vaccine
Intervention  ICMJE
  • Biological: VACCINE: placebo
    0.5 mL, single intra-muscular injection
  • Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
    0.5 mL, single intra-muscular injection
    Other Name: 13vPnC
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Biological: VACCINE: placebo
  • Experimental: 13-valent pneumococcal conjugate vaccine
    Intervention: Biological: VACCINE: 13-valent pneumococcal conjugate vaccine
Publications *

*   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: September 24, 2010)
84496
Original Estimated Enrollment  ICMJE
 (submitted: August 28, 2008)
85000
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female adults aged 65 years or older on the day of vaccination and able to fulfill study requirements.

Exclusion Criteria:

  • Previous vaccination with any licensed or experimental pneumococcal vaccine
  • Residence in a nursing home, long-term care facility, or similar facility
  • Known hypersensitivity to vaccination
  • Immune deficiency or suppression
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00744263
Other Study ID Numbers  ICMJE 6115A1-3006
B1851025
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2014

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