Invasive Streptococcus Pneumoniae Disease Clinical Trial
Official title:
An Alternative Booster Vaccine Against Meningitis and Ear Infections.
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).
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).
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention