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Pneumococcal Polysaccharide Serotype 1 is a bacterial polysaccharide antigen used in pneumococcal conjugate vaccines. It is one of ten serotypes included in Synflorix, a pneumococcal polysaccharide conjugate vaccine (adsorbed) authorised in the European Union.[2] The full registry name describes the serotype 1 polysaccharide conjugated to protein D, a carrier protein derived from non-typeable Haemophilus influenzae, and adsorbed on aluminium phosphate.[1] The product is supplied by GlaxoSmithKline Biologicals S.A. under the trade name Synflorix.[1]
As a conjugate vaccine component, the serotype 1 polysaccharide is chemically linked to a carrier protein (protein D from non-typeable Haemophilus influenzae). This conjugation helps the immune system recognise the polysaccharide and produce antibodies against the pneumococcal bacterium. The antigen is adsorbed on aluminium phosphate, which acts as an adjuvant to enhance the immune response.[2] The vaccine does not contain live bacteria; it contains purified polysaccharides from the bacterial capsule.
The vaccine is formulated as a suspension for injection and is given by intramuscular use. Each 0.5 ml dose of Synflorix contains 1 microgram of pneumococcal polysaccharide serotype 1 conjugated to protein D carrier protein and adsorbed on aluminium phosphate.[2] The product is available in pre-filled syringes and vials, including single-dose and multidose presentations.[2]
One completed Phase 2 trial (2023-505154-18-00) investigated a monovalent pneumococcal conjugate candidate, with Synflorix used as a comparator. The trial enrolled 100 healthy toddlers aged 11 to 15 months.[1] The primary outcomes were prompted local reactions (redness, swelling, and pain at the injection site), prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), adverse events, and serious adverse events.[1] The trial status is completed, meaning the study has finished.[1]
The Phase 2 trial measured local reactions such as redness, swelling, and pain at the injection site, as well as systemic events including fever, decreased appetite, drowsiness/increased sleep, and irritability.[1] The trial also recorded adverse events and serious adverse events.[1] The supplementary sources provided do not list specific side effect frequencies for Synflorix.
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