– Prevention of invasive infections, pneumonia and acute otitis media due to Streptococcus pneumoniae, in children from 6 weeks of age
Composition, forms, route of administration
– 10 or 13 valent pneumococcal polysaccharide conjugate vaccine
– Suspension for injection:
• 10 valent vaccine: in multidose vials
• 13 valent vaccine: in monodose and multidose vials
– For IM injection into the anterolateral part of the thigh in children < 2 years and into the deltoid muscle in children ≥ 2 years. DO NOT ADMINISTER INTO THE GLUTEAL MUSCLE.
Dosage and vaccination schedule
– Child: 0.5 ml per dose
– Child from 6 weeks to < 12 months:
• 3p+0 schedule
3 doses 4 weeks apart at 6, 10 and 14 weeks of age
• 2p+1 schedule
2 doses 8 weeks apart and a booster dose between 9 and 15 months
– Child from 12 months to < 2 years: 2 doses 8 weeks apart
– Child from 2 to 5 years: a single dose
Contra-indications, adverse effects, precautions
– Do not administer in the event of allergic reactions to a previous dose of vaccine.
– Vaccination should be postponed in the event of severe acute febrile illness; minor infections are not contra-indications.
– May cause: mild local reactions (redness and pain at the injection site), fever, irritability, drowsiness, loss of appetite; rarely: seizures, anaphylactic reactions.
– If administered simultaneously with other vaccines, use different syringes and injection sites.
– If the vaccination is interrupted before the complete series has been administered, continue the vaccination schedule from where it was interrupted, do not repeat administration of the previous dose.
– Choice of vaccines and vaccination schedule: follow national recommendations.
– Shake before use to homogenise the vaccine.
– Storage: between 2 °C and 8 °C. Do not freeze -
• 10 valent vaccine, 2 dose vial: if open vial is not used entirely within 6 hours it should be discarded.
• 10 and 13 valent vaccine, 4 dose vial: if open vial is not entirely used it can be stored for 28 days, providing the cold chain is respected.