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.
Although NIMENRIX contains tetanus toxoid, this vaccine does not substitute for tetanus immunization.
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 (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.
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.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
Individuals with certain complement deficiencies and individuals 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.
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 14.4 Immunogenicity: Immunogenicity in infants). 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 rabbit complement serum bactericidal assay (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 one year post vaccination, the percentage of subjects achieving rSBA titres ≥1:8 for groups A, C, W-135 and Y were: 63.5%, 49.1%, 65.3% and 73.1% in the one dose group, and 70.6%, 55.2%, 77.6% and 79.7% in the two doses group (see 14.4 Immunogenicity: Immunogenicity in toddlers aged 12-23 months).
One month post-vaccination, a single dose vaccination was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with two doses given 2 months apart, while responses to groups A and C were higher in the two groups. The clinical relevance of these observations is unknown. If a toddler is expected to be at particular 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 after an interval of 2 months. At one year post-vaccination, the percentage of subjects achieving hSBA responses ≥1:8 for groups A, C, W-135 and Y were 35.7%, 80.3%, 95.8% and 91.9% in the one dose group, and 35.5%, 90.5%, 98.5% and 87.9% in the two doses group. Regarding waning of antibody against group A or group C after a first dose of NIMENRIX in children aged 12-23 months, see 7 WARNINGS AND PRECAUTIONS - 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 14.4 Immunogenicity). 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.
Similar to the monovalent Men C comparator, 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 14.4 Immunogenicity).
Reproductive Health: Female and Male Potential
See 7.1.1 Pregnant Women.
7.1 Special Populations
7.1.1 Pregnant Women
There is limited experience with use of NIMENRIX in pregnant women.
Animal studies with NIMENRIX do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryo/fetal development, parturition or post-natal development (see 16 NON-CLINICAL TOXICOLOGY).
NIMENRIX should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the fetus.
The safety of NIMENRIX when administered to breast-feeding women has not been evaluated. It is unknown whether NIMENRIX is excreted in human breast milk.
NIMENRIX should only be used during breast-feeding when the possible advantages outweigh the potential risks.
Pediatrics (≥ 6 weeks of age): The safety and efficacy of NIMENRIX in pediatric subjects 6 weeks of age and older have been established.
Geriatrics (≥ 65 years of age): Limited safety and immunogenicity data are available in subjects 56 years of age and older (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS).