Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

PHASE4CompletedINTERVENTIONAL
Enrollment

908

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

January 31, 2013

Conditions
Pneumococcal Vaccines
Interventions
BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

BIOLOGICAL

INFANRIX hexa

INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

DRUG

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.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

BIOLOGICAL

INFANRIX hexa

INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

DRUG

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.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

BIOLOGICAL

INFANRIX hexa

INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

DRUG

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.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

BIOLOGICAL

INFANRIX hexa

INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

DRUG

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.

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

BIOLOGICAL

INFANRIX hexa

INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

Trial Locations (14)

39-200

Gabinet Lekarski, Dębica

31-302

Hanna Czajka Indywidualna Praktyka Lekarska, Krakow

31-422

"NZOZ Praktimed sp. z o.o.", Krakow

91-347

Specjalistyczna Praktyka Lekarska Gravita, Lodz

21-100

SP ZOZ Lubartow, Lubartów

20-044

NZOZ Praktyka Lekarza Rodzinnego Eskulap, Lublin

55-120

NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak, Oborniki Śląskie

61-734

Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy, Poznan

41-103

NZLA Michalkowice Jarosz i Partnerzy, Siemianowice Śląskie

87-100

NZOZ Nasz Lekarz, Torun

55-100

Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny, Trzebnica

02-127

DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy, Warsaw

50-345

Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu, Wroclaw

21-010

NZOZ Salmed, Łęczna

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY

NCT01392378 - Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13® | Biotech Hunter | Biotech Hunter