Warnings And 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.
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 meningococcal polysaccharideserogroups A, C, W-135 and Y even if they develop antibodies following vaccination with NIMENRIX.
Safety and immunogenicity have not been assessed in patients with increased susceptibility to meningococcal infection due to conditions such as terminal complement deficiencies and anatomic or functional asplenia. In these individuals, an adequate immune response may not be elicited.
Protection Against Meningococcal Disease
NIMENRIX will only confer protection against Neisseria meningitidis serogroups A, C, W-135 and Y. The vaccine will not protect against other Neisseria meningitidis serogroups.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Immune responses in toddlers aged 12-14 months
At one month post-dose, toddlers aged 12-14 months had similar rabbit complement serum bactericidal assay (rSBA) responses to groups A, C, W-135 and Y following one dose of NIMENRIX or two doses of NIMENRIX given two months apart.
A single dose was associated with lower human complement serum bactericidal assay (hSBA) titres to groups W-135 and Y compared with two doses given two months apart. Similar responses to groups A and C were observed after one or two doses (see CLINICAL TRIALS - Immunogenicity in toddlers aged 12-23 months). The clinical relevance of the findings is unknown. If a toddler is expected to be at particular risk of invasive meningococcal disease due to exposure to groups W-135 and Y, consideration may be given to administering a second dose after an interval of 2 months. Regarding waning of antibody against MenA or MenC after a first dose of NIMENRIX in children aged 12-23 months, see WARNINGS AND PRECAUTIONS - Persistence of serum bactericidal antibody titres.
Persistence of serum bactericidal antibody titres
Persistence of antibodies has been evaluated up to 5 years after vaccination. The persistence studies with NIMENRIX have shown a waning of serum bactericidal antibody titres against MenA when using human complement in the assay (hSBA) (see CLINICAL TRIALS – Persistence of Immune Response). The clinical relevance of the waning of hSBA MenA antibody titres is unknown. Currently there is limited information available on the safety of a booster dose. However, if an individual is expected to be at particular risk of exposure to MenA and received a dose of NIMENRIX more than approximately one 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 the waning antibody titres is unknown. A booster dose might be considered in individuals vaccinated at toddler age remaining at high risk of exposure to meningococcal disease caused by groups A, C, W-135 and Y (see CLINICAL TRIALS – Booster Response).
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 TOXICOLOGY).
NIMENRIX should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the fetus.
Nursing Women: The safety of NIMENRIX when administered to breastfeeding 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.