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Pneumococcal Polysaccharide Serotype 14 is the full registry name for one of the active components of Synflorix, a pneumococcal polysaccharide conjugate vaccine (adsorbed). In the CTIS product records, the substance appears as part of a fixed combination with nine other pneumococcal polysaccharide serotypes, each conjugated to a carrier protein derived from non-typeable Haemophilus influenzae, tetanus toxoid or diphtheria toxoid.[1] The product is authorised as a medicine in the European Union under several authorisation records, and the authorisation holder is GlaxoSmithKline Biologicals S.A.[1] The substance belongs to the therapeutic areas of bacterial infections and mycoses and respiratory tract diseases.[1]
Vaccines work by teaching the immune system how to defend itself against a disease. Pneumococcal conjugate vaccines such as Synflorix contain small amounts of polysaccharides, a type of sugar, extracted from the capsule that surrounds the Streptococcus pneumoniae bacterium. These polysaccharides are purified and then conjugated, meaning attached, to a carrier protein that helps the immune system recognise them. This prepares the body to defend itself against invasive disease and pneumonia caused by S. pneumoniae.[2] Serotype 14 is one of the pneumococcal serotypes included in the vaccine to provide protection against that specific type of the bacterium.
The substance is formulated as a suspension for injection and is given by intramuscular use.[1] In the registered trial, the intervention was a 0.5 ml dose of Synflorix suspension for injection in a pre-filled syringe, administered intramuscularly.[1] Authorised pneumococcal conjugate vaccines are given as an injection into the muscle of the thigh in infants and the upper arm in older children and adults.[2]
The registry data contains one completed Phase 2 clinical trial, EU CT number 2023-505154-18-00, which enrolled 100 healthy toddlers aged 11 to 15 months.[1] The study was interventional and investigated a monovalent pneumococcal conjugate candidate administered as a 2-dose series. The primary outcomes measured were prompted local reactions such as redness, swelling and pain at the injection site, prompted systemic events including fever, decreased appetite, drowsiness or increased sleep, and irritability, as well as adverse events and serious adverse events.[1] The trial status is completed, meaning the study has finished and results are being or have been analysed.[1]
The supplementary sources do not provide a specific list of side effects for Pneumococcal Polysaccharide Serotype 14 alone. The registered trial measured local reactions at the injection site, including redness, swelling and pain, and systemic events such as fever, decreased appetite, drowsiness and irritability.[1] These are the reactions that were systematically collected as safety outcomes in the Phase 2 study in healthy toddlers.
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