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Pneumococcal polysaccharide serotype 19F conjugated to diphtheria toxoid carrier protein adsorbed on aluminium phosphate is one of ten pneumococcal polysaccharide serotypes contained in the authorised vaccine Synflorix. Synflorix is a pneumococcal polysaccharide conjugate vaccine (adsorbed) supplied as a suspension for injection in a pre-filled syringe.[2] The vaccine is authorised in the European Union and is held by GlaxoSmithKline Biologicals S.A.[1] In the EU clinical trial registry, the substance appears as an auxiliary medicine in six trial records, meaning it is used as a supporting or comparison product rather than the main investigational substance.[1]
Pneumococcal conjugate vaccines contain polysaccharides from the surface of Streptococcus pneumoniae bacteria, chemically linked (conjugated) to a carrier protein. In Synflorix, serotype 19F is conjugated to a diphtheria toxoid carrier protein and adsorbed on aluminium phosphate.[2] The body is expected to develop an immune response against the injected serotypes, which would help in prevention of disease caused by Streptococcus pneumoniae.[3] The carrier protein enhances the immune response, particularly in young children whose immune systems respond less well to plain polysaccharides.
Synflorix is given as a 0.5 ml suspension for injection by intramuscular use.[2] Each 0.5 ml dose contains 3 micrograms of pneumococcal polysaccharide serotype 19F conjugated to diphtheria toxoid carrier protein (3 to 6 micrograms) and adsorbed on aluminium phosphate.[2] The vaccine is supplied in pre-filled syringes and vials, in pack sizes of 1, 10, 50 or 100 units.[2] In the Phase 2 trial, the monovalent candidate containing serotype 19F was given as a 0.5 ml intramuscular injection.[1]
The EU clinical trial registry contains one completed Phase 2 trial that included pneumococcal polysaccharide serotype 19F as part of a monovalent pneumococcal conjugate candidate in healthy toddlers.[1] The trial enrolled 100 children aged 11 to 15 months and investigated the safety and immunogenicity of the candidate when administered as a 2-dose series.[1]
The primary outcomes measured were prompted local reactions at the injection site (redness, swelling and pain), prompted systemic events (fever, decreased appetite, drowsiness or increased sleep, and irritability), 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.
The most common adverse events reported with pneumococcal conjugate vaccines include injection site pain or tenderness. Other common systemic adverse events reported are fever and injection site redness.[3] There is a remote chance of a severe allergic reaction, which may very rarely occur after a dose.[3] Signs of a severe allergic reaction can include difficulty in breathing and rash all over the body.[3]
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