The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
400
GSK Investigational Site
Brno, Czechia
GSK Investigational Site
Hradec Králové, Czechia
GSK Investigational Site
Jindřichův Hradec, Czechia
GSK Investigational Site
Náchod, Czechia
Occurrence of fever > or = to 38°C (rectal temperature)
Safety, reactogenicity and immunogenicity pre and post-vaccination
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GSK Investigational Site
Ostrava, Czechia
GSK Investigational Site
Pardubice, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Prague, Czechia
GSK Investigational Site
Znojmo, Czechia