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The powder is white. The suspension is an opalescent, colourless to pale brownish liquid.
After reconstitution, one dose (0.5 mL) contains: RSVPreF31 antigen2,3 120 micrograms.
1 Respiratory Syncytial Virus recombinant glycoprotein F stabilised in the pre-fusion conformation = RSVPreF3.
2 RSVPreF3 produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
3 adjuvanted with AS01E containing: plant extract Quillaja saponaria Molina, fraction 21 (QS-21) 25 micrograms; 3-O-desacyl-4'-monophosphoryl lipid A (MPL) from Salmonella minnesota 25 micrograms.
Excipients/Inactive Ingredients: Powder (RSVPreF3 antigen): Trehalose dihydrate, Polysorbate 80 (E 433), Potassium dihydrogen phosphate (E 340), Dipotassium phosphate (E 340).
Suspension (AS01E Adjuvant System): Dioleoyl phosphatidylcholine (E 322), Cholesterol, Sodium chloride, Anhydrous disodium phosphate (E 339), Potassium dihydrogen phosphate (E 340), Water for injections.
