Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Preterm Compared to Term Infants.
NCT ID: NCT01193335
Last Updated: 2017-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
200 participants
INTERVENTIONAL
2010-10-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: Preterm infants
Infant born at \< 37 weeks of gestation.
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Group 2: Term infants
Infants born at ≥ 37 weeks of gestation
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Interventions
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13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous anaphylactic reaction or allergy to any vaccine
* Contraindication to vaccination
* Known or suspected immune deficiency or immune suppression
* Major known congenital malformation or serious chronic disorder
* Significant neurological disorder
* Participation to another study
42 Days
98 Days
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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NZOZ "HIPOKRATES-II" Sp. z o.o.
Krakow, , Poland
Hanna Czajka Indywidualna Praktyka Specjalistyczna Lekarska
Krakow, , Poland
SP ZOZ Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego w Lodzi
Lodz, , Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem
Poznan, , Poland
Szpital im. Sw. Jadwigi Slaskiej, Oddzial Pediatryczny
Trzebnica, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, , Poland
Hospital Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Complejo Hospitalario DE Torrecardenas
Almería, Almeria, Spain
Complexo Hospitalario Xeral Cies
Vigo, Pontevedra, Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario de La Paz
Madrid, , Spain
Complejo Hospitalario de Navarra
Pamplona, , Spain
Countries
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References
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Martinon-Torres F, Wysocki J, Center KJ, Czajka H, Majda-Stanislawska E, Omenaca F, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Blazquez-Gamero D, Moreno-Galarraga L, Giardina PC, Sun G, Gruber WC, Scott DA, Gurtman A. Circulating Antibody 1 and 2 Years After Vaccination With the 13-Valent Pneumococcal Conjugate Vaccine in Preterm Compared With Term Infants. Pediatr Infect Dis J. 2017 Mar;36(3):326-332. doi: 10.1097/INF.0000000000001428.
Martinon-Torres F, Czajka H, Center KJ, Wysocki J, Majda-Stanislawska E, Omenaca F, Bernaola Iturbe E, Blazquez Gamero D, Concheiro-Guisan A, Gimenez-Sanchez F, Szenborn L, Giardina PC, Patterson S, Gruber WC, Scott DA, Gurtman A. 13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants. Pediatrics. 2015 Apr;135(4):e876-86. doi: 10.1542/peds.2014-2941. Epub 2015 Mar 16.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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6096A1-4001
Identifier Type: OTHER
Identifier Source: secondary_id
2009-017332-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B1851037
Identifier Type: -
Identifier Source: org_study_id
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