At a glance
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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
In Brief
A Phase 4 clinical trial evaluating 13-valent pneumococcal conjugate vaccine, INFANRIX hexa, and 2 other interventions for Pneumococcal Vaccines. Completed, enrolled 908 participants across 14 sites.
Detailed 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.
Study Details
Timeline
Interventions
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
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.
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
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.
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
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.
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
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.
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.