In short
Pneumococcal Polysaccharide Serotype 14 is one of ten pneumococcal polysaccharide components in the authorised vaccine Synflorix, a pneumococcal polysaccharide conjugate vaccine (adsorbed) developed by GlaxoSmithKline Biologicals S.A. It is given by intramuscular injection and is already authorised as a medicine in the EU. The clinical trial data includes one completed Phase 2 study in 100 healthy toddlers that assessed safety and immunogenicity of a monovalent pneumococcal conjugate candidate.
Key points
- Authorised medicine: the substance is part of Synflorix, an EU-authorised pneumococcal conjugate vaccine.
- One completed Phase 2 trial in 100 healthy toddlers investigated a monovalent pneumococcal conjugate candidate.
- Condition studied: prevention of pneumococcal infections.
- Primary measures: local and systemic reactions, adverse events and serious adverse events.
- Route: intramuscular injection as a suspension for injection.
- Developer: GlaxoSmithKline Biologicals S.A.
What is pneumococcal polysaccharide serotype 14?
Pneumococcal Polysaccharide Serotype 14 is the full registry name for one of the active components of Synflorix, a pneumococcal polysaccharide conjugate vaccine (adsorbed). In the CTIS product records, the substance appears as part of a fixed combination with nine other pneumococcal polysaccharide serotypes, each conjugated to a carrier protein derived from non-typeable Haemophilus influenzae, tetanus toxoid or diphtheria toxoid. The product is authorised as a medicine in the European Union under several authorisation records, and the authorisation holder is GlaxoSmithKline Biologicals S.A. The substance belongs to the therapeutic areas of bacterial infections and mycoses and respiratory tract diseases.
How does pneumococcal polysaccharide serotype 14 work?
Vaccines work by teaching the immune system how to defend itself against a disease. Pneumococcal conjugate vaccines such as Synflorix contain small amounts of polysaccharides, a type of sugar, extracted from the capsule that surrounds the Streptococcus pneumoniae bacterium. These polysaccharides are purified and then conjugated, meaning attached, to a carrier protein that helps the immune system recognise them. This prepares the body to defend itself against invasive disease and pneumonia caused by S. pneumoniae. Serotype 14 is one of the pneumococcal serotypes included in the vaccine to provide protection against that specific type of the bacterium.
Which conditions is it used or studied for?
- Pneumococcal infections: the registered Phase 2 trial studied a monovalent pneumococcal conjugate candidate in healthy toddlers to describe its safety profile and immune response, in the context of preventing pneumococcal infections.
- Pneumonia and invasive pneumococcal disease: authorised pneumococcal conjugate vaccines protect against pneumonia and invasive diseases caused by Streptococcus pneumoniae.
- Acute otitis media: pneumococcal conjugate vaccines are also used in children from 6 weeks to 17 years of age to protect against acute otitis media, an ear infection.
How is pneumococcal polysaccharide serotype 14 given?
The substance is formulated as a suspension for injection and is given by intramuscular use. In the registered trial, the intervention was a 0.5 ml dose of Synflorix suspension for injection in a pre-filled syringe, administered intramuscularly. Authorised pneumococcal conjugate vaccines are given as an injection into the muscle of the thigh in infants and the upper arm in older children and adults.
What do the clinical trials show?
The registry data contains one completed Phase 2 clinical trial, EU CT number 2023-505154-18-00, which enrolled 100 healthy toddlers aged 11 to 15 months. The study was interventional and investigated a monovalent pneumococcal conjugate candidate administered as a 2-dose series. The primary outcomes measured were prompted local reactions such as redness, swelling and pain at the injection site, prompted systemic events including fever, decreased appetite, drowsiness or increased sleep, and irritability, as well as adverse events and serious adverse events. The trial status is completed, meaning the study has finished and results are being or have been analysed.
What side effects are known?
The supplementary sources do not provide a specific list of side effects for Pneumococcal Polysaccharide Serotype 14 alone. The registered trial measured local reactions at the injection site, including redness, swelling and pain, and systemic events such as fever, decreased appetite, drowsiness and irritability. These are the reactions that were systematically collected as safety outcomes in the Phase 2 study in healthy toddlers.