Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
NCT ID: NCT00368966
Last Updated: 2012-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
619 participants
INTERVENTIONAL
2006-10-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
13-valent Pneumococcal Conjugate Vaccine
2
7-valent Pneumococcal Conjugate Vaccine
Interventions
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13-valent Pneumococcal Conjugate Vaccine
7-valent Pneumococcal Conjugate Vaccine
Eligibility Criteria
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Inclusion Criteria
* Available for the entire study period
Exclusion Criteria
* Known contraindication to vaccination
42 Days
98 Days
ALL
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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A Coruña, A Coruna, Spain
Ferrol, A Coruna, Spain
Santiago de Compostela, A Coruna, Spain
Almería, Almeria, Spain
Almería, Almeria, Spain
Almería, Almeria, Spain
Argentona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Spain
Sant Adrià de Besòs, Barcelona, Spain
Sant Cugat del Vallès, Barcelona, Spain
Sant Cugat del Vallès, Barcelona, Spain
Bilbao, Bizkaia, Spain
A Coruña, La Coruna, Spain
Burela de Cabo, Lugo, Spain
Alcorcón, Madrid, Spain
Fuenlabrada, Madrid, Spain
Getafe, Madrid, Spain
Getafe, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Móstoles, Madrid, Spain
Parla, Madrid, Spain
Antequera, Malaga, Spain
Málaga, Malaga, Spain
Pamplona, Navarre, Spain
Ourense, Ourense, Spain
Vigo, Pontevedra, Spain
Seville, Sevilla, Spain
Burjassot, Valencia, Spain
L'Eliana, Valencia, Spain
Quart de Poblet, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Countries
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References
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Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-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.
Gimenez-Sanchez F, Kieninger DM, Kueper K, Martinon-Torres F, Bernaola E, Diez-Domingo J, Steul K, Juergens C, Gurtman A, Giardina P, Liang JZ, Gruber WC, Emini EA, Scott DA; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Aug 11;29(35):6042-8. doi: 10.1016/j.vaccine.2011.06.026. Epub 2011 Jun 23.
Other Identifiers
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6096A1-501
Identifier Type: -
Identifier Source: org_study_id