An Alternative Booster Vaccine Against Meningitis and Ear Infections
Condition: Invasive Streptococcus Pneumoniae Disease
MeSH terms: Pneumonia, Pneumococcal; Otitis; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination
      (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called
      Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein
      called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence
      that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used
      vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains
      only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two
      of the three additional serotypes included in PCV-13 which might be enough to protect
      children against disease caused by these two serotypes. Furthermore, previous studies have
      shown that PHiD-CV confers protection against a common otitis media pathogen in children
      called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D,
      which is derived from NTHi. In addition, the use of a carrier protein, which is not closely
      related to an antigen included in any coadministered or previously administered routine
      vaccine minimises the risk of interference related to it.

      The investigators aim to recruit 168 healthy children at the age of 12 months who have
      already received two doses of PCV-13 according to the UK routine immunisation schedule at 2
      and 4 months of age. Participants will then be randomised to receive a booster dose of either
      PCV-13 or PHiD-CV at 12 months of age.

      Three visits will take place at their parents' home and will involve a blood test followed by
      a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month
      after visit 1) and 3 (1 year after visit 1).
    

Detailed description: 
      Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13
      pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at
      2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV)
      may be at least as good as the currently used vaccine when used as an alternative vaccine at
      12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it
      generates cross-reactive antibodies against two of the three additional serotypes included in
      PCV-13 which might be enough to protect children against disease caused by these two
      serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a
      common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by
      attachment to a carrier protein called Protein D, which is derived from NTHi. In addition,
      the use of a carrier protein, which is not closely related to an antigen included in any
      coadministered or previously administered routine vaccine minimises the risk of interference
      related to it.

      The investigators aim to recruit 168 healthy children at the age of 12 months who have
      already received two doses of PCV-13 according to the UK routine immunisation schedule at 2
      and 4 months of age. Participants will then be randomised to receive a booster dose of either
      PCV-13 or PHiD-CV at 12 months of age.

      Three visits will take place at their parents' home and will involve a blood test followed by
      a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month
      after visit 1) and 3 (1 year after visit 1).
    

Intervention name(s): 13-valent pneumococcal conjugate vaccine; 10-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age; The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumococcal conjugate vaccine; invasive pneumococcal disease; vaccination; children