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 valentpneumococcal 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 deltoidmuscle 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.
Remarks
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.