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

• 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.
• 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.
• 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.
• 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.

• Experimental: Group 1
  
  Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
  Interventions:
  

  • Biological: 13-valent pneumococcal conjugate vaccine
  • Biological: INFANRIX hexa
  • Drug: Paracetamol
• Experimental: Group 2
  
  Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
  Interventions:
  

  • Biological: 13-valent pneumococcal conjugate vaccine
  • Biological: INFANRIX hexa
  • Drug: Ibuprofen
• Experimental: Group 3
  
  Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
  Interventions:
  

  • Biological: 13-valent pneumococcal conjugate vaccine
  • Biological: INFANRIX hexa
  • Drug: Paracetamol
• Experimental: Group 4
  
  Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
  Interventions:
  

  • Biological: 13-valent pneumococcal conjugate vaccine
  • Biological: INFANRIX hexa
  • Drug: Ibuprofen
• Experimental: Group 5
  
  Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.
  Interventions:
  

  • Biological: 13-valent pneumococcal conjugate vaccine
  • Biological: INFANRIX hexa

Inclusion Criteria:

• Aged 2 months (56 to 98 days) at time of enrollment.
• Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

• Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Allergy or contraindication to paracetamol or ibuprofen administration.
• Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.