Nimenrix Special Precautions

Nimenrix should under no circumstances be administered intravascularly, intradermally or subcutaneously.
It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable effects) and a clinical examination.
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.
Intercurrent illness: As with other vaccines, vaccination with Nimenrix should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
Syncope: Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
Subjects previously vaccinated with a plain polysaccharide meningococcal vaccine and vaccinated with Nimenrix 30 to 42 months later had lower Geometric Mean Titres (GMTs) measured with rabbit complement serum bactericidal assay (rSBA) than subjects who had not been vaccinated with any meningococcal vaccine in the preceding 10 years. Clinical relevance of this observation is unknown.
Thrombocytopenia and coagulation disorders: As with other vaccines administered intramuscularly, Nimenrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Immunodeficiency: It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis groups A, C, W-135 and Y even if they develop antibodies following vaccination with Nimenrix.
Special populations: Limited data are available on the safety and immunogenicity in individuals with increased susceptibility to meningococcal infection due to anatomic or functional asplenia (such as sickle cell disease) (see Dosage & Administration, Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
Protection against meningococcal disease: Nimenrix will only confer protection against Neisseria meningitidis groups A, C, W-135 and Y. The vaccine will not protect against other Neisseria meningitidis groups.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Immune response in infants aged 6 months to less than 12 months: A single-dose administered at 6 months was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with three doses administered at 2, 4, and 6 months (see Pharmacology: Pharmacodynamics under Actions). The clinical relevance of this observation is unknown. If an infant aged 6 months to less than 12 months is expected to be at immediate risk of invasive meningococcal disease due to exposure to groups W-135, and/or Y, consideration may be given to administering a second primary dose of Nimenrix after an interval of 2 months.
Immune responses in toddlers aged 12-14 months: At 1 month post vaccination, toddlers aged 12-14 months had similar rSBA titres to groups A, C, W-135, and Y following one dose of Nimenrix or two doses of Nimenrix given 2 months apart. At 1 year post vaccination, the rSBA titres to groups A, C, W-135 and Y were similar in both the one and the two dose groups (see Pharmacology: Pharmacodynamics under Actions).
Measured with a serum bactericidal assay using hSBA, 1 month post vaccination, responses to groups W-135 and Y were lower after a single dose than after 2 doses given 2 months apart, while responses to groups A and C were similar in the two groups (see Pharmacology: Pharmacodynamics under Actions). The clinical relevance of these observations is unknown. If a toddler is expected to be at immediate risk of invasive meningococcal disease due to the exposure to groups W-135 and/or Y, consideration may be given to administering a second primary dose after an interval of 2 months. At 1 year post vaccination, the hSBA responses for groups A, C, W-135 and Y were similar in both the one and the two dose groups (see Pharmacology: Pharmacodynamics under Actions). Regarding waning of antibody against group A or group C after a first dose of Nimenrix in children aged 12-23 months, see under Persistence of serum bactericidal antibody titres.
Persistence of serum bactericidal antibody titres: Persistence of antibodies has been evaluated up to 10 years after vaccination. The persistence studies with Nimenrix have shown a waning of serum bactericidal antibody titres against group A when using human complement in the assay (hSBA) (see Pharmacology: Pharmacodynamics under Actions). The clinical relevance of this observation is unknown. However, if an individual is expected to be at particular risk of exposure to group A and received a dose of Nimenrix more than approximately 1 year previously, consideration may be given to administering a booster dose.
A decline in antibody titres over time has been observed. The clinical relevance of this observation is unknown. A booster dose might be considered in individuals remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 and Y (see Pharmacology: Pharmacodynamics under Actions).
Although Nimenrix contains tetanus toxoid, this vaccine does not substitute for tetanus immunization.
Effects on Ability to Drive and Use Machines: No studies on the effects of Nimenrix on the ability to drive and use machines have been performed.