Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Condition: Pneumococcal Vaccines
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; INFANRIX hexa; Paracetamol; 13-valent pneumococcal conjugate vaccine; INFANRIX hexa; Ibuprofen; 13-valent pneumococcal conjugate vaccine; INFANRIX hexa; Paracetamol; 13-valent pneumococcal conjugate vaccine; INFANRIX hexa; Ibuprofen; 13-valent pneumococcal conjugate vaccine; INFANRIX hexa
Intervention type(s): Biological; Biological; Drug; Biological; Biological; Drug; Biological; Biological; Drug; Biological; Biological; Drug; Biological; Biological
Intervention description(s): 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.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prevenar 13; 13vPnC; Antipyretic medication; Healthy subjects