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Pneumococcal polysaccharide serotype 9V conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein adsorbed on aluminium phosphate is a bacterial polysaccharide component of a pneumococcal conjugate vaccine. One 0.5 ml dose of Synflorix contains 1 microgram of the serotype 9V polysaccharide, conjugated to 9–16 micrograms of protein D carrier and adsorbed on aluminium phosphate.[3] The substance is part of Synflorix, a vaccine authorised in the European Union under marketing authorisation numbers EU/1/09/508/002 through EU/1/09/508/005, held by GlaxoSmithKline Biologicals S.A.[1] Serotype 9V is one of ten pneumococcal serotypes included in this authorised vaccine.[3]
Pneumococcal conjugate vaccines link a bacterial polysaccharide to a carrier protein to strengthen the immune response. In Synflorix, the serotype 9V polysaccharide is conjugated to protein D, a carrier derived from non-typeable Haemophilus influenzae.[3] The conjugate helps the immune system recognise the polysaccharide and generate antibodies against Streptococcus pneumoniae bacteria expressing serotype 9V. Pneumococcal serotypes differ in their potential for colonisation, invasiveness and virulence; serotypes with low invasive potential can still be associated with high case-fatality rates once they become invasive.[4]
The substance is formulated as a suspension for injection, given by intramuscular use.[1] Synflorix is available in 0.5 ml pre-filled syringes and vials, including multidose vials of 2.0 ml.[3] In the Phase 2 trial, a monovalent pneumococcal conjugate candidate containing serotype 9V was administered as a 0.5 ml intramuscular injection in a 2-dose series.[1]
One completed Phase 2 trial (EU CT number 2023-505154-18-00) evaluated a monovalent pneumococcal conjugate candidate in 100 healthy toddlers aged 11 to 15 months.[1] The study compared the candidate against Synflorix and other pneumococcal conjugate components, including a serotype 3 conjugate adsorbed on aluminium phosphate and PF-07831695.[1] The primary outcomes were prompted local reactions at the injection site (redness, swelling and pain), prompted systemic events (fever, decreased appetite, drowsiness/increased sleep and irritability), adverse events and serious adverse events.[1] The trial was interventional and has been completed.[1]
The Phase 2 trial measured injection-site reactions and systemic events as primary outcomes, including redness, swelling, pain, fever, decreased appetite, drowsiness and irritability.[1] These are the reactions the study set out to record; the registry record does not report the frequency of each reaction. No other side-effect data are provided in the sources for this page.
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