Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
NCT ID: NCT01392378
Last Updated: 2014-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
908 participants
INTERVENTIONAL
2011-08-31
2013-01-31
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
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Paracetamol
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Group 2
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Ibuprofen
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Group 3
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Paracetamol
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Group 4
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Ibuprofen
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Group 5
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Interventions
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13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Paracetamol
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Ibuprofen
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Paracetamol
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Ibuprofen
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
Eligibility Criteria
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Inclusion Criteria
* Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Allergy or contraindication to paracetamol or ibuprofen administration.
* Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
56 Days
98 Days
ALL
Yes
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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Gabinet Lekarski
Dębica, , Poland
Hanna Czajka Indywidualna Praktyka Lekarska
Krakow, , Poland
NZOZ "Praktimed" sp. z o.o.
Krakow, , Poland
Specjalistyczna Praktyka Lekarska Gravita
Lodz, , Poland
SP ZOZ Lubartow
Lubartów, , Poland
NZOZ Praktyka Lekarza Rodzinnego Eskulap
Lublin, , Poland
NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Śląskie, , Poland
Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy
Poznan, , Poland
NZLA Michalkowice Jarosz i Partnerzy
Siemianowice Śląskie, , Poland
NZOZ Nasz Lekarz
Torun, , Poland
Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny
Trzebnica, , Poland
DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy
Warsaw, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, , Poland
NZOZ Salmed
Łęczna, , Poland
Countries
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References
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Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, Czajka H, Hasiec B, Dziduch J, Jackowska T, Witor A, Kopinska E, Konior R, Giardina PC, Sundaraiyer V, Patterson S, Gruber WC, Scott DA, Gurtman A. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017 Apr 4;35(15):1926-1935. doi: 10.1016/j.vaccine.2017.02.035. Epub 2017 Mar 3.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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6096A1-4027
Identifier Type: -
Identifier Source: secondary_id
B1851047
Identifier Type: -
Identifier Source: org_study_id
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