Meningococcal vaccines - ATC code: J07AH07

meningococcal group c conjugate vaccine

One dose (0.5ml) contains: Neisseria meningitidis (strain C11) Serogroup C oligosaccharide……………… 10 micrograms Conjugated to Corynebacterium diphtheriae CRM197 carrier protein…………approximately 15 micrograms Adsorbed on aluminium phosphate … 0.125 mg Al3+

Suspension for injection, in pre-filled syringe. After shaking, the vaccine is a homogeneous, white suspension.

Active immunisation of children from 2 months of age, adolescents and adults for the prevention of invasive disease caused by Neisseria meningitis serogroup C.

The use of Meningitec should be determined on the basis of official recommendations.

There are no data on the use of different Meningococcal serogroup C conjugate vaccines within the primary series or for boosting. Whenever possible, the same vaccine should be used throughout.

Primary immunisation

Infants up to the age of 12 months: two doses, each of 0.5 mL, the first dose given not earlier than 2 months of age and with an interval of at least 2 months between doses.

Children over the age of 12 months, adolescents and adults: a single dose of 0.5 mL.

The timing of the doses should be in accordance with official recommendations.

Booster doses

It is recommended that a booster dose should be given after completion of the primary immunisation series in infants. The timing of this dose should be in accordance with available official recommendations.

The need for booster doses in subjects primed with a single dose (i.e. aged 12 months or more when first immunised) has not yet been established

There are no data on the use of different Meningococcal serogroup C conjugate vaccines within the primary series or for boosting. Whenever possible, the same vaccine should be used throughout.

Primary immunisation

Infants up to the age of 12 months: two doses, each of 0.5 mL, the first dose given not earlier than 2 months of age and with an interval of at least 2 months between doses.

Children over the age of 12 months, adolescents and adults: a single dose of 0.5 mL.

The timing of the doses should be in accordance with official recommendations.

Booster doses

It is recommended that a booster dose should be given after completion of the primary immunisation series in infants. The timing of this dose should be in accordance with available official recommendations.

The need for booster doses in subjects primed with a single dose (i.e. aged 12 months or more when first immunised) has not yet been established

• Hypersensitivity to the active substances or to any of the excipients.

• Hypersensitivity to any vaccine containing diphtheria toxoid or non-toxic diphtheria toxin protein.

• Hypersensitivity after previous administration of Meningitec.

• As with other vaccines, the administration of Meningitec should be postponed in subjects suffering from an acute severe febrile illness.

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactoid/anaphylactic event following the administration of the vaccine.

As with any intramuscular injection, the vaccine should be given with caution to individuals with thrombocytopenia or any coagulation disorder or to those receiving anticoagulation therapy.

Meningitec will only confer protection against serogroup C of Neisseria meningitidis and may not completely prevent meningococcal serogroup C disease. It will not protect against other groups of Neisseria meningitidis or other organisms that cause meningitis or septicaemia. In the event of petechiae and/or purpura following vaccination, the aetiology should be thoroughly investigated. Both infective and non-infective causes should be considered.

Although symptoms of meningism such as neckpain/stiffness or photophobia have been reported there is no evidence that the vaccine causes meningococcal C meningitis. Clinical alertness to the possibility of co-incidental meningitis should therefore be maintained.

Consideration should be given to the risk of Neisseria meningitidis serogroup C disease in a given population and the perceived benefits of immunisation before the institution of a widespread immunisation programme.

No data on the applicability of the vaccine to outbreak control are available.

The safety and immunogenicity have not been established in infants below the age of two months.

There are limited data on safety and immunogenicity of the vaccine in the adult population and there are no data in adults aged 65 years and older.

Limited data are available on the use of Meningitec in immunodeficient subjects. In individuals with impaired immune responsiveness (whether due to the use of immunosuppressive therapy, a genetic defect, human immunodeficiency virus (HIV) infection, or other causes) the expected immune response to meningococcal serogroup C conjugate vaccines may not be obtained. The implications for the actual degree of protection against infection are unknown, since this will depend also on whether the vaccine has elicited an immunological memory response. Individuals with complement deficiencies and individuals with functional or anatomical asplenia may mount an immune response to meningococcal serogroup C conjugate vaccines; however, the degree of protection that would be afforded is unknown.

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.

Immunisation with this vaccine does not substitute for routine diphtheria vaccination.

Meningitec SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVENOUSLY.

Meningitec must not be mixed with other vaccines in the same syringe. Separate injection sites should be used if more than one vaccine is being administered.

Administration of Meningitec at the same time as (but, for injected vaccines, at a different injection site) the following vaccines did not reduce the immunological response to any of these other antigens in clinical trials:

Oral Polio vaccine (OPV); Inactivated Polio vaccine (IPV); Hepatitis B vaccine (HBV); diphtheria and tetanus vaccine alone (D or T), in combination (DT or dT), or in combination with whole cell or acellular Pertussis vaccine (DTwP or DTaP); Haemophilus influenzae type b conjugate vaccine (Hib alone or in combination with other antigens) or combined Measles, Mumps, and Rubella vaccine (MMR).

Minor variations in geometric mean antibody concentrations (GMCs) or titres (GMTs) were observed between studies; however, the clinical significance, if any, of these observations is not established.

Data that support concomitant administration of Meningitec and an acellular Pertussis vaccine (i.e. DTaP) or an Inactivated Polio vaccine (IPV) are derived from studies in which subjects received either Meningitec or the same meningococcal serogroup C conjugate as in Meningitec combined with an investigational pneumococcal conjugate vaccine and from a study of concomitant administration with the Infanrix Hexa paediatric combination vaccine (DTaP-HBV-IPV/Hib).

In various studies with different vaccines, concomitant administration of meningococcal serogroup C conjugates with combinations containing acellular pertussis components (with or without inactivated polio viruses, hepatitis B surface antigen or Hib conjugates) has been shown to result in lower SBA GMTs compared to separate administrations or to co-administration with whole cell pertussis vaccines. The proportions reaching SBA titres of at least 1:8 or 1:128 are not affected. At present, the potential implications of these observations for the duration of protection are not known.

In a clinical trial that compared separate with concomitant administrations of Meningitec (two doses at 2 and 6 months and a booster dose at approximately 12 months) and Prevenar (pneumococcal conjugate 7-valent vaccine; three doses at 2, 3.5, 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.

Note: the following descriptions of frequency have been defined as: Very common (10%); Common (1% and <10%); Uncommon (0.1% and <1%); Rare (0.01% and <0.1%); Very rare (<0.01%), not known (cannot be estimated from the available data).

Adverse Reactions from Clinical Trials

Adverse reactions reported across all age groups are provided below. Adverse reactions were collected on the day of vaccination and the following three days. The majority of reactions were self-limiting and resolved within the follow-up period.

In all age groups injection site reactions (including redness, swelling and tenderness/pain) were very common. However, these were not usually clinically significant. Redness or swelling of at least 3 cm and tenderness interfering with movement for more than 48 hours was infrequent where studied. Transient injection site tenderness was reported in 70% of adults during clinical trials.

Fever of at least 38.0°C was common in infants and toddlers and very common in pre-school children, but did not usually exceed 39.1°C, particularly in older age groups.

In infants and toddlers crying was common after vaccination while drowsiness, impaired sleeping, anorexia, diarrhoea and vomiting were very common. Irritability was very common in infants and in toddlers and common in children aged between 3.5 and 6 years. There was no evidence that these were related to Meningitec rather than concomitant vaccines, particularly DTP.

In trials that evaluated three-dose schedules (2, 3 and 4 months or 2, 4 and 6 months) in infants, rates of adverse events did not increase with successive doses with the exception of fever 38°C. However, it should be noted that infants received other scheduled vaccines concomitantly with Meningitec in these studies.

Myalgia was common in adults. Somnolence was commonly reported in children between 3.5 and 6 years of age and in adults. Headache was common in children between 3.5 and 6 years of age and was very common in adults.

Adverse reactions reported across all age groups are provided below.

Adverse Reactions from Post Marketing Surveillance (for all age groups)

These frequencies are based on spontaneous reporting rates and have been calculated using number of reports and number of doses distributed.

There have been very rare reports of seizures following Meningitec vaccination; individuals have usually rapidly recovered. Some of the reported seizures may have been faints. The reporting rate of seizures was below the background rate of epilepsy in children. In infants seizures were usually associated with fever and were likely to be febrile convulsions.

There have been very rare spontaneous reports of hypotonic-hyporesponsive episode (HHE), a condition characterised by hypotonia and reduced responsiveness in association with pallor or cyanosis, in temporal association with the administration of meningococcal serogroup C conjugate vaccine. In most cases, meningococcal serogroup C conjugate vaccine was administered concomitantly with other vaccines, the majority of which were pertussis-containing vaccines.

Relapse of nephrotic syndrome has been reported in association with Meningococcal serogroup C conjugate vaccines.

Very rarely, petechiae and/or purpura have been reported following immunisation.

Apnoea in very premature infants ( 28 weeks of gestation).

Pfizer Limited

(POM)

15 February 2012