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Pneumococcal polysaccharide serotype 7F conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein adsorbed on aluminium phosphate is one of the antigen components of Synflorix, a pneumococcal polysaccharide conjugate vaccine (adsorbed). The full registered name for the combination lists ten pneumococcal serotype components, including serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F, each conjugated to a carrier protein — either protein D from non-typeable Haemophilus influenzae, tetanus toxoid, or diphtheria toxoid.[1] The vaccine is already authorised as a medicine in the European Union under the product name Synflorix, with marketing authorisation held by GlaxoSmithKline Biologicals S.A.[1] In the NHS dictionary of medicines, the product is classified under ATC code J07AL02, which identifies it as a pneumococcal conjugate vaccine.[2]
Pneumococcal conjugate vaccines work by linking (conjugating) the polysaccharide capsule of Streptococcus pneumoniae — the bacterium that causes pneumococcal disease — to a carrier protein. This conjugation makes the polysaccharide visible to the immune system in a way that plain polysaccharide vaccines cannot achieve in young children, allowing infants and toddlers to produce a protective immune response.[3] The serotype 7F component in Synflorix uses protein D derived from non-typeable Haemophilus influenzae as its carrier protein, adsorbed on aluminium phosphate to enhance the immune response.[1]
Synflorix is a suspension for injection supplied in 0.5 ml pre-filled syringes and is given by intramuscular use.[2] The registered pharmaceutical form in the EU trial records is suspension for injection, with the route of administration recorded as intramuscular use.[1] The NHS dictionary of medicines confirms the product is a prescribable product with a route of intramuscular administration.[2]
One completed Phase 2 trial is registered in the EU Clinical Trials Information System for a monovalent pneumococcal conjugate candidate, with Synflorix serving as an auxiliary comparator in the study design.[1] The trial enrolled 100 healthy toddlers aged 11 to 15 months and gave the candidate as a 2-dose series by intramuscular injection.[1] The primary outcomes measured safety and immunogenicity, including prompted local reactions such as redness, swelling, and pain at the injection site, prompted systemic events such as fever, decreased appetite, drowsiness, and irritability, as well as adverse events and serious adverse events.[1] The trial status is completed, meaning the study has finished.[1]
The Phase 2 trial measured local reactions at the injection site — redness, swelling, and pain — and systemic events including fever, decreased appetite, drowsiness or increased sleep, and irritability.[1] These are the expected reactions that were being assessed in the trial; the trial also recorded adverse events and serious adverse events.[1]
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