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Pneumococcal polysaccharide serotype 19F conjugated to CRM197 is one of the active components of pneumococcal conjugate vaccines. It consists of the polysaccharide (sugar) coating from serotype 19F of the bacterium Streptococcus pneumoniae, chemically linked to a carrier protein called CRM197, which is a non-toxic variant of diphtheria toxin.[2] In the EU clinical trial registry, the substance is listed as part of a fixed combination in two product records and is classified under the therapeutic area of bacterial infections and mycoses.[1]
The substance appears in authorised vaccines. In the product information for Synflorix, a related pneumococcal conjugate vaccine, serotype 19F is present at a dose of 3 micrograms per 0.5 ml dose, conjugated to diphtheria toxoid carrier protein.[2] The substance is also a component of Vaxneuvance, a 15-valent pneumococcal polysaccharide conjugate vaccine authorised in the European Union under authorisation record EU/1/21/1591/003.[1] Other trade names for pneumococcal conjugate vaccines containing this serotype include Prevenar 13 and Prevenar 20.[3]
Pneumococcal conjugate vaccines work by presenting the polysaccharide coating of the pneumococcal bacterium to the immune system. Linking the polysaccharide to a carrier protein such as CRM197 makes the immune response stronger, especially in infants whose immune systems do not respond well to polysaccharides alone. This conjugation allows the body to produce antibodies against the serotype, which can help protect against infections caused by that serotype of Streptococcus pneumoniae.[2]
The substance is given as part of a suspension for injection, administered by intramuscular injection.[1] In the EU product records, the pharmaceutical form is a suspension for injection, and the route of administration is intramuscular.[1] The Synflorix product information describes a 0.5 ml dose containing 3 micrograms of serotype 19F polysaccharide, adsorbed on aluminium phosphate.[2] Pre-filled syringes and vials are available for related pneumococcal conjugate vaccines.[2][3]
One Phase 3 interventional trial in the EU Clinical Trials Information System is studying a 21-valent pneumococcal conjugate vaccine (PCV21) that contains pneumococcal polysaccharide serotype 19F conjugated to CRM197. The trial enrolled 1,113 healthy infants from approximately 2 months of age and is currently authorised.[1]
The trial compares PCV21 against the 15-valent Vaxneuvance (15vPCV). The primary outcomes include the seroresponse rate and IgG concentration for the serotypes shared between the two vaccines and for the six serotypes unique to PCV21. The study aims to demonstrate non-inferiority of the antibody response for shared serotypes and superiority for the six additional serotypes, measured at 30 days after the toddler dose.[1]
In the trial, the substance appears both as the test product and as a comparator: Vaxneuvance serves as the comparison vaccine, while the 21-valent vaccine containing serotype 19F is the test product.[1]
The supplementary sources provided for this page do not contain specific side effect information for pneumococcal polysaccharide serotype 19F conjugated to CRM197. The published study on pneumococcal polysaccharide vaccination in adults focuses on antibody responses and does not report a detailed side effect profile in the excerpt provided.[4]
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