Presentation and Status in Health Basket
1 X 0.5 ml
The immunisation schedules for this vaccine should be based on official recommendations.
Infants from 6 weeks to 6 months of age: Three-dose primary series. The recommended immunisation series to ensure optimal protection 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. A booster (fourth) dose is recommended at least 6 months after the last priming dose and preferably between 12 and 15 months of age.
Preterm newborn infants (born between 27-36 weeks gestation): In preterm infants born after at least 27 weeks of gestational age, the recommended immunisation series consists of four doses, each of 0.5ml. 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. A booster (fourth) dose is recommended at least 6 months after the last primary dose.
Unvaccinated infants and children ≥ 7 months of age: infants aged 7-11 months: The vaccination schedule consists of two primary doses of 0.5 ml with an interval of at least 1 month between doses. A booster (third) dose is recommended in the second year of life with an interval of at least 2 months after the last primary dose. children aged 12 months – 5 years: The vaccination schedule consists of two doses of 0.5 ml with an interval of at least 2 months between doses. It is recommended that subjects who receive a first dose of this vaccine complete the full vaccination course with this vaccine.
Paediatric population: The safety and efficacy of this vaccine in children over 5 years of age have not been established.
Method of administration: The vaccine should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children.
Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F in infants and children from 6 weeks up to 5 years of age. The use of the vaccine should be determined on the basis of official recommendations taking into consideration the impact pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.
Hypersensitivity to the active substances or to any of the excipients, or to any of the carrier proteins. As with other vaccines, the administration of Pneumcoccal vaccine 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.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h 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. Pneumcoccal vaccine should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of Pneumcoccal vaccine.
In children as of 2 years of age, syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints. As for other vaccines administered intramuscularly, Pneumcoccal vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Official recommendations for the immunisation against diphtheria, tetanus and Haemophilus influenzae type b should also be followed.
There is insufficient evidence that Pneumcoccal vaccine provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A or against non-typeable Haemophilus influenzae. Pneumcoccal vaccine does not provide protection against other micro-organisms.
As with any vaccine, Pneumcoccal vaccine may not protect all vaccinated individuals against invasive pneumococcal disease Pneumonia or otitis media caused by the serotypes in the vaccine and the cross-reactive serotype 19A. In addition, as otitis media and pneumonia are caused by many micro-organisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the serotypes in the vaccine and serotype 19A.
Pneumcoccal vaccine is indicated for use in children aged from 6 weeks up to 5 years. Children should receive the dose regimen of Pneumcoccal vaccine that is appropriate to their age at the time of commencing the vaccination series. Safety and immunogenicity data are not yet available in children above 5 years of age.
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to vaccination.
Safety and immunogenicity data in children with increased risk for pneumococcal infections (e.g. sickle cell disease, congenital and acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome) are not yet available for Pneumcoccal vaccine. Vaccination in high-risk groups should be considered on an individual basis.
Children younger than 2 years old should receive the appropriate-for-age Pneumcoccal vaccine 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 immunocompromised) 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 Pneumcoccal vaccine should receive 23-valent pneumococcal polysaccharide vaccine. The interval between the pneumococcal conjugate vaccine (Pneumcoccal vaccine) 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 pneumococcal polysaccharide vaccine to Pneumcoccal vaccine primed children may result in hyporesponsiveness to further doses of pneumococcal polysaccharide or to pneumococcal conjugate vaccine.
Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions. Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate. The clinical data suggest that paracetamol might reduce the immune response to Pneumcoccal vaccine. However, the clinical relevance of this observation is not known.
The use of prophylactic antipyretic medicinal products is recommended: For all children receiving Pneumcoccal vaccine simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions. For children with seizure disorders or with a prior history of febrile seizures. Antipyretic treatment should be initiated according to local treatment guidelines.
Appetite lost, irritability, drowsiness, pain, redness, swelling at the injection site, fever and injection site reactions like injection site induration.
See prescribing information for full details.
Use with other vaccines: Pneumcoccal vaccine can be given concomitantly with any of the following monovalent or combination vaccines [including DTPa-HBV-IPV/Hib and DTPw-HBV/Hib]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), hepatitis B vaccine (HBV), inactivated polio vaccine (IPV), Haemophilus influenzae type b vaccine (Hib), diphtheria-tetanus-whole cell pertussis vaccine (DTPw), measles-mumps-rubella vaccine (MMR), varicella vaccine (V), meningococcal serogroup C conjugate vaccine (CRM197 and TT conjugates), meningococcal serogroups A, C, W-135 and Y conjugate vaccine (TT conjugate), oral polio vaccine (OPV) and oral rotavirus vaccine. Different injectable vaccines should always be given at different injection sites.
Clinical studies demonstrated that the immune responses and the safety profiles of the co-administered vaccines were unaffected, with the exception of the inactivated poliovirus type 2 response, for which inconsistent results were observed across studies (seroprotection ranging from 78% to 100%). In addition when the meningococcal serogroups A, C, W-135 and Y vaccine (TT conjugate) was co-administered with a booster dose of Pneumcoccal vaccine during the second year of life in children primed with 3 doses of Pneumcoccal vaccine, lower antibody geometric mean concentration (GMC) and opsonophagocytic assay geometric mean titre (OPA GMT) were observed for one pneumococcal serotype (18 C). There was no impact of co-administration on the other nine pneumococcal serotypes. Enhancement of antibody response to Hib-TT conjugate, diphtheria and tetanus antigens was observed. The clinical relevance of the above observations is unknown.
Use with systemic immunosuppressive medicinal products: As with other vaccines, it may be expected that in patients receiving immunosuppressive treatment an adequate response may not be elicited.
Use with prophylactic administration of antipyretics: See prescribing information for full details.
Pregnancy and Lactation
Pregnancy: This vaccine is not intended for use in adults. Human data on the use during pregnancy and animal reproduction studies are not available.
Lactation: Pneumcoccal vaccine is not intended for use in adults. Human data on the use during lactation and animal reproduction studies are not available.
No case of overdose has been reported.
Special precautions for storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Store in the original package in order to protect from light.
Shelf life: The expiry date of the vaccine is indicated on the label and packaging. After first opening of the multidose vial, immediate use is recommended. If not used immediately, the vaccine should be stored in a refrigerator (2°C – 8°C). If not used within 6 hours it should be discarded.