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Pneumococcal polysaccharide serotype 5 is one of the sugar-coating (polysaccharide) components of the bacterium Streptococcus pneumoniae, also called pneumococcus. In the vaccine Synflorix, this polysaccharide is conjugated (chemically linked) to a carrier protein called protein D, which is derived from non-typeable Haemophilus influenzae, and adsorbed on aluminium phosphate.[2] The full registered name is PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN ADSORBED ON ALUMINIUM PHOSPHATE. Synflorix is an authorised medicine in the European Union, with authorisation records including EU/1/09/508/002 to EU/1/09/508/005, and the authorisation holder is GlaxoSmithKline Biologicals S.A.[1][2] In the trial register, the substance appears as an auxiliary substance in six trial records and is part of a fixed combination in six product records.[1]
Polysaccharides are sugars on the bacterial surface that the immune system recognises. When linked to a carrier protein, these sugars trigger a stronger immune response than the polysaccharide alone, especially in young children. Research published in the 1980s compared the serological response to serotype 5 polysaccharide given alone or as part of a 15-valent vaccine in adults, and found that the serotype 5 polysaccharide was immunogenic (able to provoke an immune response) with no reciprocal interference with the other 14 polysaccharides.[3] The tolerance of the serotype 5 polysaccharide was reported to be as good as that of the other antigens.[3]
This vaccine component is used to help protect against infections caused by Streptococcus pneumoniae. The trial in the EU register lists one condition:
According to the older epidemiological study, serotype 5 was in France the fourth pneumococcal serotype for acute pneumonia (9.1%) and bacteraemia (6.9%), and was more frequently encountered in Africa, where it was among the more often isolated serotypes in meningitis.[3]
The product containing this component, Synflorix, is a suspension for injection given by intramuscular use.[1] The authorised presentations include pre-filled syringes and vials, each containing a 0.5 ml dose, with pack sizes ranging from 1 to 100 units.[2] One 0.5 ml dose contains 1 microgram of pneumococcal polysaccharide serotype 5, conjugated to protein D carrier protein, and adsorbed on aluminium phosphate (0.5 milligram Al3+).[2] In the clinical trial, the vaccine was given as a 0.5 ml intramuscular injection.[1]
The EU Clinical Trials register lists one completed Phase 2 trial (identifier 2023-505154-18-00) in which this substance appears as an auxiliary component. The trial enrolled 100 healthy toddlers aged 11 to 15 months and studied a monovalent pneumococcal conjugate candidate (PF-07831695) given as a 2-dose series, with Synflorix used as a comparison.[1]
The trial's primary outcomes were prompted local reactions (redness, swelling, and pain at the injection site), prompted systemic events (fever, decreased appetite, drowsiness or increased sleep, and irritability), and adverse events including serious adverse events.[1] The stated purpose was to describe the safety profile of the candidate vaccine when administered as a 2-dose series to children aged 11 to 15 months.[1] The trial status is Completed.[1]
In the older adult study, the tolerance of the serotype 5 polysaccharide was reported to be as good as that of the other 14 antigens in the vaccine.[3] The Phase 2 trial in toddlers measured local reactions such as redness, swelling and pain at the injection site, and systemic events such as fever, decreased appetite, drowsiness or increased sleep, and irritability, as well as adverse events and serious adverse events.[1] The results of that trial are not provided in the registry record.
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