In short
Pneumococcal polysaccharide serotype 4 conjugated to CRM197 is one of 15 pneumococcal polysaccharide components in Vaxneuvance, an authorised pneumococcal conjugate vaccine. It is being studied as a test substance and comparator in a Phase 3 trial involving 1,113 healthy infants. The trial compares a 21-valent pneumococcal conjugate vaccine (PCV21) against the 15-valent Vaxneuvance (15vPCV) for pneumococcal immunisation.
Key points
- Phase 3 trial in pneumococcal immunisation with 1,113 healthy infants from approximately 2 months of age.
- The trial compares PCV21 against 15vPCV (Vaxneuvance), which contains the serotype 4 conjugate.
- Primary outcomes measure seroresponse rate and IgG concentration for PCV21 and 15vPCV serotypes.
- The trial is authorised in the EU Clinical Trials Information System under number 2023-507600-32-00.
- Vaxneuvance is authorised as a medicine in the EU and given as a 0.5 mL intramuscular injection.
What is pneumococcal polysaccharide serotype 4 conjugated to CRM197?
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). 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. The vaccine holds a marketing authorisation in the European Union, with authorisation records including EU/1/21/1591/003. 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.
How does pneumococcal polysaccharide serotype 4 conjugated to CRM197 work?
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). 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.
Which conditions is it used or studied for?
- Pneumococcal immunisation — protection against infections caused by Streptococcus pneumoniae, including the serotype 4 strain.
- Pneumococcal disease in healthy infants — the authorised Phase 3 trial studies immunisation starting from approximately 2 months of age.
How is pneumococcal polysaccharide serotype 4 conjugated to CRM197 given?
Pneumococcal polysaccharide serotype 4 conjugated to CRM197 is given as part of Vaxneuvance, a suspension for injection in a pre-filled syringe. The route of administration is intramuscular injection, with a single dose of 0.5 mL. The authorised presentations include pre-filled syringes with or without needles, in pack sizes of 1, 10, or 50 syringes.
What do the clinical trials show?
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. The trial compares PCV21, a 21-valent pneumococcal conjugate vaccine, against 15vPCV (Vaxneuvance). 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. 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.
What side effects are known?
The provided sources do not list specific side effects for pneumococcal polysaccharide serotype 4 conjugated to CRM197.