Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

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NCT00708682

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Study Location
Guadalajara, Jalisco, 44080, Mexico
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vaccines, Pneumococcal
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone

- Able to complete three blood draws during study

- At least 3.5 kg at enrollment

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


- Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to
vaccines


- Immune deficiency, bleeding disorder or significant chronic medical condition

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Vaccines, PneumococcalStudy Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico NCT00708682
  1. Guadalajara, Jalisco
  2. Morelia, Michoacan
  3. Cuernavaca, Morelos
  4. Monterrey, Nuevo Leon
  5. Merida, Yucatan
  6. Distrio Federal,
  7. Distrio Federal,
  8. Oaxaca,
  9. Puebla,
ALL GENDERS
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Vaccines, PneumococcalStudy Evaluating 13-valent Pneumococcal Conjugate Vaccine In Healthy Infants NCT00444457
  1. Benton, Arkansas
  2. Conway, Arkansas
  3. Fayetteville, Arkansas
  4. Jonesboro, Arkansas
  5. Little Rock, Arkansas
  6. North Little Rock, Arkansas
  7. Downey, California
  8. Fontana, California
  9. Fountain Valley, California
  10. Lakewood, California
  11. Loma Linda, California
  12. Moreno Valley, California
  13. Paramount, California
  14. Riverside, California
  15. Rolling Hills Estates, California
  16. Boulder, Colorado
  17. Longmont, Colorado
  18. Norwich, Connecticut
  19. Palm Beach Gardens, Florida
  20. Tampa, Florida
  21. Atlanta, Georgia
  22. Marietta, Georgia
  23. Woodstock, Georgia
  24. Nampa, Idaho
  25. Chicago, Illinois
  26. Dekalb, Illinois
  27. Bardstown, Kentucky
  28. Crestview Hills, Kentucky
  29. Louisville, Kentucky
  30. Louisville, Kentucky
  31. Boston, Massachusetts
  32. Boston, Massachusetts
  33. Fall River, Massachusetts
  34. Jamaica Plain, Massachusetts
  35. Jackson, Mississippi
  36. St. Louis, Missouri
  37. Omaha, Nebraska
  38. Omaha, Nebraska
  39. Lebanon, New Hampshire
  40. Whitehouse Station, New Jersey
  41. Bronx, New York
  42. Fishkill, New York
  43. Hopewell Jct, New York
  44. Ithaca, New York
  45. Syracuse, New York
  46. Cary, North Carolina
  47. Durham, North Carolina
  48. Durham, North Carolina
  49. Sylva, North Carolina
  50. Bismark, North Dakota
  51. Fargo, North Dakota
  52. Cincinnati, Ohio
  53. Cleveland, Ohio
  54. Huber Heights, Ohio
  55. Kettering, Ohio
  56. Mason, Ohio
  57. Tulsa, Oklahoma
  58. Kittanning, Pennsylvania
  59. Latrobe, Pennsylvania
  60. Pittsburgh, Pennsylvania
  61. Pittsburgh, Pennsylvania
  62. Pittsburgh, Pennsylvania
  63. Clarksville, Tennessee
  64. Franklin, Tennessee
  65. Jackson, Tennessee
  66. Kingsport, Tennessee
  67. Galveston, Texas
  68. San Antonio, Texas
  69. Layton, Utah
  70. Murray, Utah
  71. South Jordan, Utah
  72. Vienna, Virginia
  73. Vancouver, Washington
  74. Vancouver, Washington
  75. Vancouver, Washington
  76. LaCrosse, Wisconsin
  77. Marshfield, Wisconsin
  78. Monroe, Wisconsin
ALL GENDERS
42 Days+
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MULTIPLE SITES
Vaccines, PneumococcalStudy Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants NCT00366899
  1. Napoli, Campania
  2. Napoli, Campania
  3. Bologna, Emilia Romagna
  4. Roma, Lazio
  5. Roma, Lazio
  6. Genova, Liguria
  7. Milan, Lombardia
  8. Novara, Piemonte
  9. Taranto, Puglia
  10. Sassari, Sardegna
  11. Ragusa, Sicilia
  12. Palermo, Sicillia
  13. Firenze, Toscana
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Vaccines, PneumococcalStudy to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants. NCT00368966
  1. Ferrol, A Coruna
  2. Santiago de Compostela, A Coruna
  3. Argentona, Barcelona
  4. Sabadell, Barcelona
  5. Sant Adria de Besos, Barcelona
  6. Sant Cugat del Valles, Barcelona
  7. Sant Cugat del Valles, Barcelona
  8. Bilbao, Bizkaia
  9. Burela, Lugo
  10. Alcorcon, Madrid
  11. Fuenlabrada, Madrid
  12. Getafe, Madrid
  13. Getafe, Madrid
  14. Mostoles, Madrid
  15. Parla, Madrid
  16. Antequera, Malaga
  17. Pamplona, Navarra
  18. Vigo, Pontevedra
  19. Burjassot, Valencia
  20. La Eliana, Valencia
  21. Quart de Poblet, Valencia
  22. A Coruna,
  23. Almeria,
  24. Almeria,
  25. Almeria,
  26. Barcelona,
  27. Barcelona,
  28. La Coruna,
  29. Madrid,
  30. Madrid,
  31. Malaga,
  32. Ourense,
  33. Sevilla,
  34. Valencia,
  35. Valencia,
  36. Valencia,
  37. Valencia,
  38. Valencia,
  39. Valencia,
  40. Valencia,
  41. Valencia,
ALL GENDERS
42 Days+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico
Official Title  ICMJE A Phase 3, Open Label, Single Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Mexico
Brief Summary The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal
Intervention  ICMJE Biological: 13-valent pneumococcal conjugate vaccine
Study Arms  ICMJE Experimental: A
Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Publications * Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinón-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

*   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: January 28, 2011)		225
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2008)		214
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
  • Able to complete three blood draws during study
  • At least 3.5 kg at enrollment

Exclusion Criteria:

  • Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
  • Immune deficiency, bleeding disorder or significant chronic medical condition
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00708682
Other Study ID Numbers  ICMJE 6096A1-3009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2011

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