Generic Name

Drug Description

Presentation

Indications

Active immunisation against invasive disease (including sepsis, meningitis, bacteraemic pneumonia, bacteraemia) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in: - infants and young children from 2 months of age to 2 years of age - previously unvaccinated children aged 2 years to 5 years. For the number of doses to be administered in the different age groups.

The use of Prevenar should be determined on the basis of official recommendations taking into consideration variability of serotype epidemiology in different geographical areas as well as the impact of invasive disease in different age groups.

Child Dosage

The vaccine should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.

Immunisation schedules:

The immunisation schedules for Prevenar should be based on official recommendations.

Infants aged 2 - 6 months:

The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A fourth dose is recommended in the second year of life.

Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered. The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age.

Previously unvaccinated older infants and children:

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 aged 24 months – 5 years: one single dose.

The need for a booster dose after these immunisation schedules has not been established.

Contra Indications

Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid.

Special Precautions

As with other vaccines, the administration of Prevenar should be postponed in subjects suffering from acute moderate or severe febrile illness.

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.

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.

Prevenar will not protect against other Streptococcus pneumoniae serotypes than those included in the vaccine nor other micro-organisms that cause invasive disease or otitis media.

This vaccine should not be given to infants or children with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.

Although some antibody response to diphtheria toxoid may occur, immunisation with this vaccine does not substitute for routine diphtheria immunisation.

For children from 2 years through 5 years of age, a single dose immunization schedule was used. A higher rate of local reactions has been observed in children older than 24 months of age compared with infants.

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 active immunisation.

Limited data have demonstrated that Prevenar (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. Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e.g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome). Vaccination in high-risk groups should be considered on an individual basis.

Children below 2 years old should receive the appropriate-for-age Prevenar vaccination series. The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children 24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or 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 Prevenar should receive 23-valent pneumococcal polysaccharide vaccine. The interval between the pneumococcal conjugate vaccine (Prevenar) 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 might result in hyporesponsiveness to further doses of Prevenar.

When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone. These reactions were mostly moderate (less than or equal to 39 °C) and transient.

Antipyretic treatment should be initiated according to local treatment guidelines.

Prophylactic antipyretic medication is recommended:

- for all children receiving Prevenar 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.

Do not administer Prevenar intravenously.

As with any vaccine, Prevenar may not protect all individuals receiving the vaccine from pneumococcal disease. Additionally, for vaccine serotypes, protection against otitis media is expected to be substantially 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.

Interactions

Prevenar can be administered simultaneously with other paediatric vaccines in accordance with the recommended immunisation schedules. Different injectable vaccines should always be given at different injection sites.

The immune response to routine paediatric vaccines co-administered with Prevenar at different injection sites was assessed in 7 controlled clinical studies. The antibody response to Hib tetanus protein conjugate (PRP-T), tetanus and Hepatitis B (HepB) vaccines was similar to controls. For CRM-based Hib conjugate vaccine, enhancement of antibody responses to Hib and diphtheria in the infant series was observed. At the booster, some suppression of Hib antibody level was observed but all children had protective levels. Inconsistent reduction in response to pertussis antigens as well as to inactivated polio vaccine (IPV) were observed. The clinical relevance of these interactions is unknown. Limited results from open label studies showed an acceptable response to MMR and varicella.

Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/Hib(PRP-T)/IPV/HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.

Sufficient data regarding interference on the concomitant administration of other hexavalent vaccines with Prevenar are currently not available.

In a clinical trial that compared separate with concomitant administrations of Prevenar (three doses at 2, 3.5, 6 months and a booster dose at approximately 12 months) and Meningitec (meningococcal C conjugate vaccine; two doses at 2 and 6 months and a booster dose at approximately 12 months) there was no evidence of immune interference between the two conjugate vaccines after the primary series or after the booster doses.

Adverse Reactions

The safety of the vaccine was assessed in different controlled clinical studies in which more than 18,000 healthy infants (6 weeks to 18 months) were included. The majority of the safety experience comes from the efficacy trial in which 17,066 infants received 55,352 doses of Prevenar. Also safety in previously unvaccinated older children has been assessed.

In all studies, Prevenar was administered concurrently with the recommended childhood vaccines.

Amongst the most commonly reported adverse reactions were injection site reactions and fever.

No consistent increased local or systemic reactions within repeated doses were seen throughout the primary series or with the booster dose, the exception being a higher rate of transient tenderness (36.5 %) and tenderness that interfered with limb movement (18.5 %) were seen with the booster dose.

In older children receiving a single dose of vaccine, a higher rate of local reactions has been observed than that previously described in infancy. These reactions were primarily transient in nature. In a post licensure study involving 115 children between 2-5 years of age, tenderness was reported in 39.1 % of children; in 15.7 % of children the tenderness interfered with limb movement. Redness was reported in 40.0 % of children, and induration was reported in 32.2 % of subjects. Redness or induration >2cm in diameter was reported in 22.6 % and 13.9% of children respectively.

When Prevenar is co-administered with hexavalent vaccines (DTaP/Hib(PRP-T)/IPV/HepB), fever 38 °C per dose was reported in 28.3 % to 48.3 % of infants in the group receiving Prevenar and the hexavalent vaccine at the same time as compared to 15.6 % to 23.4 % in the group receiving the hexavalent vaccine alone. Fever of greater than 39.5 °C per dose was observed in 0.6 to 2.8 % of infants receiving Prevenar and hexavalent vaccines.

Reactogenicity was higher in children receiving whole cell pertussis vaccines concurrently. In a study, including 1,662 children, fever of 38 °C was reported in 41.2 % of children who received Prevenar simultaneously with DTP as compared to 27.9 % in the control group. Fever of > 39 °C was reported in 3.3 % of children compared to 1.2 % in the control group.

Undesirable effects reported in clinical trials or from the post-marketing experience are listed in the following table per body system and per frequency and this is for all age groups. The frequency is defined as follows: very common: 1/10, common: 1/100 and < 1/10, uncommon: 1/1,000 and < 1/100, rare: 1/10,000 and < 1/1,000, very rare: 1/10,000.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness

Blood and lymphatic system disorders:

Immune system disorders:

Nervous system disorders:

Gastrointestinal disorders:

Skin and subcutaneous tissue disorders:

General disorders and administration site conditions:

Very common:	Injection site reactions (e.g. erythema, induration/swelling, pain/tenderness); fever 38 °C, irritability, crying, drowsiness, restless sleep.
Common:	Injection site swelling/induration and erythema >2.4 cm, tenderness interfering with movement, fever > 39 °C.
Rare:	Hypotonic hyporesponsive episode, injection site hypersensitivity reactions (eg., dermatitis, pruritus, urticaria).

Manufacturer

Drug Availability

Updated