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Pneumococcal polysaccharide serotype 4 conjugated to CRM197 is a component of the authorised medicine Vaxneuvance, also known as Pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed).[2] Vaxneuvance contains 15 pneumococcal polysaccharide serotypes, each conjugated to the CRM197 carrier protein. CRM197 is a nontoxic mutant of diphtheria toxin expressed recombinantly in Pseudomonas fluorescens.[2] The vaccine holds a marketing authorisation in the European Union, with authorisation records including EU/1/21/1591/003.[1] The product is supplied by Sanofi Pasteur Inc. and Merck Sharp & Dohme B.V. In the clinical trial listed here, the substance appears both as a test substance and as a comparator.[1]
Pneumococcal polysaccharide serotype 4 conjugated to CRM197 is designed to trigger an immune response against the serotype 4 polysaccharide of Streptococcus pneumoniae. Conjugating the polysaccharide to the CRM197 carrier protein helps the immune system recognise the polysaccharide and produce antibodies, including immunoglobulin type G (IgG).[2] Each 0.5 mL dose of Vaxneuvance contains 2.0 micrograms of pneumococcal polysaccharide serotype 4 conjugated to CRM197 and adsorbed on aluminium phosphate adjuvant.[2]
Pneumococcal polysaccharide serotype 4 conjugated to CRM197 is given as part of Vaxneuvance, a suspension for injection in a pre-filled syringe.[2] The route of administration is intramuscular injection, with a single dose of 0.5 mL.[2] The authorised presentations include pre-filled syringes with or without needles, in pack sizes of 1, 10, or 50 syringes.[2]
One Phase 3 trial, 2023-507600-32-00, is authorised and studies pneumococcal immunisation in 1,113 healthy infants from approximately 2 months of age.[1] The trial compares PCV21, a 21-valent pneumococcal conjugate vaccine, against 15vPCV (Vaxneuvance).[1] The primary outcomes are the seroresponse rate (the proportion of participants who develop a defined antibody response) and the IgG concentration for PCV21 and 15vPCV serotypes at 30 days post-toddler dose.[1] The study aims to show that PCV21 is non-inferior to 15vPCV for the shared serotypes and superior for the 6 serotypes unique to PCV21.[1]
The provided sources do not list specific side effects for pneumococcal polysaccharide serotype 4 conjugated to CRM197.
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