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Pneumococcal Polysaccharide Serotype 23F is a bacterial polysaccharide — a sugar molecule found on the surface of the bacterium Streptococcus pneumoniae. In the authorised vaccine Synflorix, this polysaccharide is chemically linked (conjugated) to a carrier protein called protein D, which is derived from non-typeable Haemophilus influenzae, and is adsorbed onto aluminium phosphate.[4] The full registry name is PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO PROTEIN D (DERIVED FROM NON-TYPEABLE HAEMOPHILUS INFLUENZAE) CARRIER PROTEIN ADSORBED ON ALUMINIUM PHOSPHATE. Synflorix is 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.[4] This substance is one component of a fixed combination product, appearing in six product records as an auxiliary substance in the trials.[1]
As part of a pneumococcal conjugate vaccine, Pneumococcal Polysaccharide Serotype 23F is designed to trigger an immune response against the 23F serotype of Streptococcus pneumoniae. The polysaccharide alone is poorly recognised by the immune system of young children, but when conjugated to a carrier protein, it stimulates the production of protective antibodies. The vaccine also contains polysaccharides from nine other serotypes: 1, 4, 5, 6B, 7F, 9V, 14, 18C, and 19F, each conjugated to carrier proteins such as protein D, tetanus toxoid, or diphtheria toxoid.[4] A separate vaccine, PNEUMOVAX 23, also includes serotype 23F among its 23 serotypes for active immunisation against pneumococcal disease.[3]
Synflorix, the vaccine containing Pneumococcal Polysaccharide Serotype 23F conjugated to protein D, is supplied as a suspension for injection in pre-filled syringes or vials, each containing a 0.5 ml dose for intramuscular use.[4] The CTIS product records confirm the pharmaceutical form as suspension for injection and the route of administration as intramuscular use.[1] In the Phase 2 trial, the vaccine was administered as a 0.5 ml intramuscular injection.[1]
One completed Phase 2 trial, 2023-505154-18-00, investigated a monovalent pneumococcal conjugate candidate containing Pneumococcal Polysaccharide Serotype 23F, among other interventions, in 100 healthy toddlers aged 11 to 15 months.[1] The trial compared Synflorix, the monovalent candidate, and PF-07831695, all given as 0.5 ml intramuscular injections. The primary outcomes measured 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]
For PNEUMOVAX 23, a different pneumococcal vaccine that also contains serotype 23F, the most common adverse reactions reported in more than 10% of vaccinated subjects in clinical trials were injection-site pain, soreness, or tenderness (60.0%), injection-site swelling or induration (20.3%), headache (17.6%), injection-site redness (16.4%), asthenia and fatigue (13.2%), and muscle pain (11.9%).[3] These side effects are from the PNEUMOVAX 23 prescribing information, not from the Synflorix trials in the CTIS data.
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