NCT01392378

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

A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 908 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 56 Days – 98 Days
• Healthy volunteers: Accepted

Summary

The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-07-12
• Last updated: 2014-02-26
• Results posted: 2014-02-26

Locations

14 sites across 1 country: Poland