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Pneumococcal polysaccharide serotype 4 is one of the active components of Synflorix, a pneumococcal polysaccharide conjugate vaccine (adsorbed) that is authorised as a medicine in the European Union.[1] The full substance name is PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN ADSORBED ON ALUMINIUM PHOSPHATE. In the registered trial, the substance appears as part of a fixed combination product containing ten pneumococcal polysaccharide serotypes.[1] The marketing authorisation holder is GlaxoSmithKline Biologicals S.A.[1]
Pneumococcal polysaccharide serotype 4 is a polysaccharide from the surface of the bacterium Streptococcus pneumoniae, conjugated to a carrier protein called protein D, which is derived from non-typeable Haemophilus influenzae.[2] Conjugating the polysaccharide to a carrier protein helps the immune system recognise and respond to the polysaccharide, which leads to the production of antibodies against this specific pneumococcal serotype. The substance is adsorbed on aluminium phosphate, which acts as an adjuvant to enhance the immune response.[2]
Pneumococcal polysaccharide serotype 4 is given as a suspension for injection by intramuscular use.[2] In the Synflorix vaccine, one dose of 0.5 ml contains 3 micrograms of pneumococcal polysaccharide serotype 4, adsorbed on aluminium phosphate and conjugated to protein D carrier protein.[2] The vaccine is presented in pre-filled syringes or vials for intramuscular injection.[2]
One registered clinical trial investigated this substance as part of a combination product. The trial, identified as 2023-505154-18-00, was a Phase 2 safety and immunogenicity study of a monovalent pneumococcal conjugate candidate in healthy toddlers.[1] The study enrolled 100 participants aged 11 to 15 months and was completed.[1] The primary outcomes measured were prompt local reactions such as redness, swelling, and pain at the injection site; prompt systemic events including fever, decreased appetite, drowsiness, and irritability; and adverse events and serious adverse events.[1] The trial aimed to describe the safety profile of the candidate when administered as a 2-dose series.[1]
The registered trial measured local reactions at the injection site, including redness, swelling, and pain, as well as systemic events such as fever, decreased appetite, drowsiness, and irritability.[1] The trial also recorded adverse events and serious adverse events to assess the safety profile of the vaccine candidate.[1]
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