Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Condition: Pneumococcal Vaccines
Intervention: 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 description: 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
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 908.0
Sex: All
Minimum age: 56 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevenar 13; 13vPnC; Antipyretic medication; Healthy subjects

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.
    

Eligibility criteria:

        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.