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1 x 0.5 ml
The immunisation schedules for Prevenar 13 should be based on official recommendations.
Infants and children aged 6 weeks to 5 years: It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.
Infants aged 6 weeks-6 months:
Three-dose primary series: The recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.
Two-dose primary series: Alternatively, when Prevenar 13 is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml, may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. The third (booster) dose is recommended between 11 and 15 months of age.
Preterm infants (<37 weeks gestation): In preterm infants, the recommended immunisation series consists of four doses, each of 0.5 ml. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age.
Unvaccinated infants and children ≥ 7 months of age:
Infants aged 7-11 months: Two doses, each of 0.5 ml, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.
Children aged 12-23 months: Two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Children and adolescents aged 2-17 years: One single dose of 0.5 ml.
Prevenar 13 vaccine schedule for infants and children previously vaccinated with Prevenar (7-valent) (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F): Prevenar 13 contains the same 7 serotypes included in Prevenar, using the same carrier protein CRM197.
Infants and children who have begun immunisation with Prevenar may switch to Prevenar 13 at any point in the schedule.
Young Children (12-59 months) completely immunised with Prevenar (7-valent): Young children who are considered completely immunised with Prevenar (7-valent) should receive one dose of 0.5 ml of Prevenar 13 to elicit immune responses to the 6 additional serotypes. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent).
Children and adolescents 5–17 years: Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of Prevenar. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of Prevenar (7-valent).
Adults ≥18 years of age, and the elderly: One single dose.
The need for revaccination with a subsequent dose of Prevenar 13 has not been established.
Regardless of prior pneumococcal vaccination status, if the use of 23-valent pneumococcal polysaccharide vaccine is considered appropriate, Prevenar 13 should be given first.
Special Populations: Individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease or HIV infection) including those previously vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine may receive at least one dose of Prevenar 13.
In individuals with an haematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of four doses of Prevenar 13, each of 0.5 ml. The primary series consists of three doses, with the first dose given at 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A fourth (booster) dose is recommended 6 months after the third dose.
Method of administration: The vaccine should be given by intramuscular injection. The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults.
Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.
Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.
The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.
Hypersensitivity to the active substances, to any of the excipients, or to diphtheria toxoid.
As with other vaccines, the administration of this drug should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Prevenar 13 must not be administered intravascularly.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
This vaccine should not be given as an intramuscular injection to individuals with thrombocytopaenia or any coagulation disorder that would contraindicate intramuscular injection, but may be given subcutaneously if the potential benefit clearly outweighs the risks.
Prevenar 13 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or otitis media. As with any vaccine, Prevenar 13 may not protect all individuals receiving the vaccine from pneumococcal disease. For the most recent epidemiological information in your country you should consult with the relevant national organisation.
Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes, may have reduced antibody response to active immunisation.
Safety and immunogenicity data are available for a limited number of individuals with sickle cell disease, HIV infection, or with an haematopoietic stem cell transplant (see section 5.1). Safety and immunogenicity data for Prevenar 13 are not available for individuals in other specific immuno-compromised groups (e.g., malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Infants and children aged 6 weeks to 5 years: In clinical studies, Prevenar 13 elicited an immune response to all thirteen serotypes included in the vaccine. The immune response for serotype 3 following the booster dose was not increased above the levels seen after the infant vaccination series; the clinical relevance of this observation regarding the induction of serotype 3 immune memory is unknown.
The proportions of functional antibody responders (OPA titres ≥ 1:8) to serotypes 1, 3 and 5 were high. However, the OPA geometric mean titres were lower than those against each of the remaining additional vaccine serotypes; the clinical relevance of this observation for protective efficacy is unknown.
Limited data have demonstrated that Prevenar 7-valent (three-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups.
Children younger than 2 years old should receive the appropriate-for-age Prevenar 13 vaccination series. The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 2 years of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness, or those who are immuno-compromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae. Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar 13 should receive 23-valent pneumococcal polysaccharide vaccine. The interval between the 13-valent pneumococcal conjugate vaccine (Prevenar 13) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks. There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar 13 might result in hyporesponsiveness to further doses of Prevenar 13.
The potential risk of apnoea and the need for respiratory monitoring for 48-72 h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation), and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
For vaccine serotypes, protection against otitis media is expected to be lower than protection against invasive disease. As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low.
When Prevenar 13 is administered concomitantly with Infanrix hexa (DTPa-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of Prevenar (7-valent) and Infanrix hexa. Increased reporting rates of convulsions (with or without fever) and hypotonic hyporesponsive episode (HHE) were observed with concomitant administration of Prevenar 13 and Infanrix hexa.
Antipyretic treatment should be initiated according to local treatment guidelines for children with seizure disorders or with a prior history of febrile seizures and for all children receiving Prevenar 13 simultaneously with vaccines containing whole cell pertussis.
Infants and children aged 6 weeks to 5 years: The safety of the vaccine was assessed in controlled clinical studies where 14,267 doses were given to 4,429 healthy infants from 6 weeks of age at first vaccination and 11-16 months of age at booster dose. In all infant studies, Prevenar 13 was co-administered with routine paediatric vaccines.
Safety in 354 previously unvaccinated children (7 months to 5 years of age) was also assessed.
The most commonly reported adverse reactions in children 6 weeks to 5 years of age were vaccination-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep.
In a clinical study in infants vaccinated at 2, 3, and 4 months of age, fever ≥ 38°C was reported at higher rates among infants who received Prevenar (7-valent) concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12 to 15 months of age, fever ≥ 38°C was reported in 50.0% of infants who received Prevenar (7-valent) and Infanrix hexa at the same time as compared to 33.6% of infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient.
An increase in vaccination-site reactions was reported in children older than 12 months compared to rates observed in infants during the primary series with Prevenar 13.
See prescribing information for full details.
Infants and children aged 6 weeks to 5 years: Prevenar 13 can be given concomitantly with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular or whole cell pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B (see guidance on Infanrix hexa), meningococcal serogroup C, measles, mumps, rubella, varicella and rotavirus vaccine.
Prevenar 13 can also be given concomitantly between 12-23 months with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine to children who have been adequately primed with Prevenar 13 (as per local recommendations).
Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and paracetamol) on the immune response to Prevenar 13 suggest that administration of paracetamol concomitantly or within the same day of vaccination may reduce the immune response to Prevenar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown.
Children and adolescents 6 to 17 years of age: No data are currently available regarding concomitant use with other vaccines.
Adults 18 to 49 years of age: No data are available regarding concomitant use with other vaccines.
Adults aged 50 years and older: Prevenar 13 may be administered concomitantly with the seasonal trivalent inactivated influenza vaccine (TIV).
In two studies conducted in adults aged 50-59 and 65 years and older, it was demonstrated that Prevenar 13 may be given concomitantly with trivalent inactivated influenza vaccine (TIV). The responses to all three TIV antigens were comparable when TIV was given alone or concomitantly with Prevenar 13.
When Prevenar 13 was given concomitantly with TIV, the immune responses to Prevenar 13 were lower compared to when Prevenar 13 was given alone, however, there was no long-term impact on circulating antibody levels.
In a third study in adults aged 50-93 years, it was demonstrated that Prevenar 13 may be given concomitantly with the seasonal quadrivalent inactivated influenza vaccine (QIV). The immune responses to all four QIV strains were noninferior when Prevenar 13 was given concomitantly with QIV compared to when QIV was given alone.
The immune responses to Prevenar 13 were noninferior when Prevenar 13 was given concomitantly with QIV compared to when Prevenar 13 was given alone. As with concomitant administration with trivalent vaccines, immune responses to some pneumococcal serotypes were lower when both vaccines were given concomitantly.
Concomitant use with other vaccines has not been investigated.
Different injectable vaccines should always be given at different vaccination sites.
Concomitant administration of Prevenar 13 and 23-valent pneumococcal polysaccharide vaccine has not been studied. In clinical studies when Prevenar 13 was given 1 year after 23-valent pneumococcal polysaccharide vaccine the immune responses were lower for all serotypes compared to when Prevenar 13 was given to subjects not previously immunised with 23-valent pneumococcal polysaccharide vaccine. The clinical significance of this is unknown.
Pregnancy and Lactation
Pregnancy: There are no data from the use of pneumococcal 13-valent conjugate vaccine in pregnant women. Therefore the use of Prevenar 13 should be avoided during pregnancy.
Lactation: It is unknown whether pneumococcal 13-valent conjugate vaccine is excreted in human milk.
Overdose with Prevenar 13 is unlikely due to its presentation as a pre-filled syringe. However, in infants and children there have been reports of overdose with Prevenar 13 defined as subsequent doses administered closer than recommended to the previous dose. In general, adverse events reported with overdose are consistent with those that have been reported with doses given in the recommended paediatric schedules of Prevenar 13.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage: Store in a refrigerator (2°C – 8°C). Do not freeze.