Meningococcal vaccine: Canadian Immunization Guide
Key information

# What
- The majority of invasive meningococcal disease (IMD) is associated with *Neisseria meningitidis- serogroups A, B, C, Y and W
- IMD is endemic in Canada but occurs at low rates, with the incidence being highest in infants
- Persons at higher risk of IMD include:
	+ those at risk due to underlying medical conditions:
		- persons with functional or anatomic asplenia, sickle cell disease, or combined T and B cell immunodeficiencies
		- persons with congenital complement, properdin, factor D or primary antibody deficiencies
		- persons with acquired complement deficiency due to receipt of the terminal complement inhibitor eculizumab (SolirisTM)
		- HIV positive individuals, especially if HIV is congenitally acquired  
		and
	+ those at risk due to exposure:
		- travellers to areas with high rates of endemic meningococcal disease or transmission, including travellers to the meningitis belt of sub-Saharan Africa and pilgrims to the Hajj in Mecca, Saudi Arabia
		- research, industrial and clinical laboratory personnel who may be at risk of exposure to *N. meningitidis*
		- military personnel who are at increased risk of meningococcal disease
		- close contacts of a case of IMD and for individuals at risk in an outbreak setting, if the disease is caused by a serogroup contained in the vaccine
- Meningococcal vaccines are initially highly effective but effectiveness wanes over time

# Who
- Healthy children: should be immunized with a monovalent conjugate C meningococcal (Men-C-C) vaccine routinely at 12 months of age; however, they may begin meningococcal immunization earlier, depending on provincial and territorial schedules. If not previously immunized as infants or toddlers, children less than 5 years of age should receive Men-C-C vaccine. It should also be considered for children 5 to 11 years of age. Additionally, a serogroup B meningococcal vaccine may be considered on an individual basis for children two months of age and older to protect against serogroup B strains expressing antigens covered by the vaccine.
- Healthy adolescents and young adults: either a Men-C-C or a quadrivalent conjugate meningococcal (Men-C-ACYW) vaccine, depending on local epidemiology and programmatic considerations, is recommended for adolescents routinely at 12 years of age, and young adults, even if they have previously been vaccinated as an infant or toddler. In addition, 4CMenB or bivalent, factor-H binding protein serogroup B meningococcal (MenB-fHBP) vaccine may be considered on an individual basis for those wishing to protect against IMD caused by relevant serogroup B strains.
- High risk individuals: Men-C-ACYW provided together with 4CMenB or MenB-fHBP vaccine is recommended for children and adults with increased risk of IMD.
- Post-exposure management: in addition to chemoprophylaxis that is recommended for close contacts, if the serogroup is vaccine-preventable, immunoprophylaxis should also be considered, depending on the exposure history.

# How
- Routine immunization:
	+ Less than 12 months: give Men-C-C vaccine to healthy infants according to provincial and territorial schedules.
	+ 12 months to 11 years of age: give one dose of Men-C-C vaccine at 12 to 23 months of age, routinely at 12 months, whether the child has been immunized as an infant or not. For previously unimmunized children less than 5 years of age, give one dose of Men-C-C vaccine. Consider one dose of Men-C-C vaccine in children aged 5 to 11 years who were previously unimmunized.
	+ 12 to 24 years of age: give adolescents, routinely at 12 years of age, and young adults one dose of either Men-C-C or Men-C-ACYW vaccine, even if previously they have been vaccinated as an infant or toddler.
- High risk individuals: The choice of vaccine and recommended schedules vary with age. Immunization with periodic booster doses with Men-C-ACYW vaccine is recommended.
- Men-C-C, 4CMenB and Men-C-ACYW-CRM vaccine may be administered concomitantly with routine childhood vaccines, and Men-C-ACYW vaccine may be administered concomitantly with adolescent and adult age-appropriate vaccines.
- MenB-fHBP may be administered concomitantly with other vaccines in individuals 10 years of age and older.
- Vaccines administered concomitantly must be at different injection sites, using separate needles and syringes.

# Why
- IMD mortality is approximately 10%.
- Of IMD survivors, 10% to 20% have long term sequelae which may include hearing loss, neurologic disabilities, and digit or limb amputations.
Epidemiology

# Disease description

## Infectious agent
Meningococcal disease is caused by an aerobic encapsulated diplococcus, *N. meningitidis- (meningococcus). Meningococcal serogroups are classified according to the immunologic reactivity of the polysaccharide capsule. Almost all invasive meningococcal disease (IMD) is associated with serogroups A, B, C, Y, and W. Meningococcal serogroups A, B, and C cause the majority of disease worldwide and are responsible for most sporadic cases and outbreaks. For additional information about *Neisseria meningitidis,- refer to the .

## Reservoir
Humans are the only reservoir for *N. meningitidis*.

## Transmission
Meningococci are transmitted person-to-person by mucosal contact with respiratory droplets from the nose and throat of infected persons. Most people who are colonized with meningococci are asymptomatic carriers.

## Risk factors
In epidemiological studies, increased incidence of IMD has been observed in individuals with: complement, properdin or factor D deficiencies; functional or anatomic asplenia; sickle cell disease; certain genetic risk factors (e.g. polymorphisms in the genes for mannose-binding lectin and tumor necrosis factor); household exposure to an infected person; recent infection with influenza; household crowding; and active and passive smoking. Persons with HIV infection may be at increased risk for meningococcal disease, especially if HIV is congenitally acquired.

## Seasonal and temporal patterns
Although disease occurs year-round, there is seasonal variation, with the majority of cases occurring in the winter and spring period in temperate climates, and in the dry season in tropical climates. Most noteworthy is the "meningitis belt" of sub-Saharan Africa where the majority of cases occur from December to June. For further information, refer to the  website.

## Spectrum of clinical illness
IMD is characterized by a short incubation period (2 to 10 days, usually 3 to 4 days) and usually presents as an acute febrile illness with rapid onset and features of meningitis or septicemia (meningococcemia), or both, and a characteristic non-blanching petechial or purpuric rash. Symptoms of meningitis include intense headache, fever, nausea, vomiting, photophobia and stiff neck. Meningococcemia is characterized by circulatory collapse, hemorrhagic skin rash and a high fatality rate. Overall mortality is approximately 10%, and 10% to 20% of survivors have long term sequelae which include hearing loss, neurologic disabilities, and digit or limb amputations.

# Disease distribution
IMD occurs sporadically worldwide and in focal epidemics. In Canada, IMD is endemic and reported year round with peaks in winter. Although people at any age can develop IMD, children younger than 5 are at the greatest risk, followed by people aged 15-19 years and 60 years and up. Serogroups B, C, W and Y are most commonly reported types in the country.
With the introduction of childhood immunization programs against serogroup C IMD in 2002, not unexpectedly, the incidence of serogroup C has decreased significantly over the years. While the incidence of serogroup B remains predominant, disease caused by serogroups W and Y have stabilized at relatively lower incidence rates.
For more information about  distribution in Canada, refer to the PHAC website. Comprehensive updates on the epidemiology of IMD in Canada are published periodically in the Canada Communicable Disease Report (CCDR).
Preparations authorized for use in Canada

# Meningococcal vaccines
Monovalent conjugate meningococcal vaccines (Men-C-C)
- MENJUGATE Liquid (meningococcal group C oligosaccharide conjugated to CRM197 protein), GlaxoSmithKline Inc., (Men-C-C-CRM)
- NeisVac-CVaccine (meningococcal group C polysaccharide conjugated to tetanus toxoids), Pfizer Canada ULC, (Men-C-C-TT)
Quadrivalent conjugate meningococcal vaccines (Men-C-ACYW)
- Menactra (meningococcal groups A, C, Y, and W polysaccharides conjugated to diphtheria toxoid protein), Sanofi Pasteur Limited, (Men-C-ACYW-DT)
- MENVEO (meningococcal groups A, C, Y and W oligosaccharides conjugated to CRM197 protein), GlaxoSmithKline Inc., (Men-C-ACYW-CRM)
- NIMENRIX (meningococcal groups A, C, Y, and W polysaccharides conjugated to tetanus toxoid protein), Pfizer Canada ULC, (Men-C-ACYW-TT)
- MenQuadfiTM (meningococcal groups A, C, Y, and W polysaccharides conjugated to tetanus toxoid protein), Sanofi Pasteur Limited, (Men-C-ACYW-TT)\*
\- NACI has not yet deliberated on the use of MenQuadfiTM. NACI will review this vaccine and update the chapter in due course. Refer to the product monograph available through Health Canada's  (DPD) for additional information regarding the use of this vaccine.
Serogroup B meningococcal vaccines
- BEXSERO (meningococcal porin A , factor H binding protein , neisserial antigen 2091 , heparin binding antigen , neisserial antigen 1030 , and Neisserial adhesion A  surface proteins), GlaxoSmithKline Inc., (4CMenB)
- Trumenba (subfamily A and B factor-H binding protein ), Pfizer Canada ULC, (MenB-fHBP)
Preparations authorized for use in Canada may not be currently available for sale. Refer to Health Canada's  for its drug status. Definitions of drug status can be found under .
For complete prescribing information, consult the product leaflet or information contained within Health Canada's authorized product monographs available through Health Canada's .
Immunogenicity, efficacy and effectiveness

# Immunogenicity
Men-C-C and Men-C-ACYW vaccines are immunogenic in infants and toddlers but those vaccinated in infancy show a waning immune response over time. Vaccination with conjugate meningococcal vaccine primes the immune system for memory and induces good anamnestic responses; however, anamnestic response may not be sufficient to prevent disease after exposure and circulating antibodies are thought to be essential. In comparison to polysaccharide meningococcal vaccine, conjugate meningococcal vaccines demonstrate greater immunogenicity and induce better immunologic memory. Conjugate meningococcal vaccines do not result in hyporesponsiveness and have been shown to overcome the hyporesponsiveness evident with polysaccharide meningococcal vaccine usage. In clinical trials, the 4CMenB vaccine has shown to be immunogenic in toddlers and children after at least two doses, and in adolescents and adults after one dose. In adolescents and adults, a more robust immune response has been observed in clinical trials following the use of a three-dose compared to a two-dose MenB-fHBP vaccine schedule.

# Efficacy and effectiveness
A study of Men-C-C vaccine demonstrated effectiveness in infants of 97% within one year of vaccination, decreasing to 68% after 1 year. Longer term vaccine effectiveness requires receipt of a booster dose in the second year of life for those immunized in infancy. Vaccine effectiveness of Men-C-ACYW-DT within 3 to 4 years of vaccination in adolescence is 80% to 85%; however, effectiveness wanes over time. There are no efficacy or effectiveness data available for Men-C-ACYW-CRM, Men-C-ACYW-TT, MenB-fHBP or 4CMenB vaccines. Vaccine effectiveness measured at the individual level may under-estimate the impact of the immunization programs on the burden of meningococcal disease in the community, due to the additional benefit conferred by herd immunity.
Recommendations for use

# Routine schedule

## Healthy infants and children (2 to 23 months of age)
Infants may receive Men-C-C vaccine beginning at 2 months of age, depending on the provincial and territorial schedule and the incidence of meningococcal serogroup C disease in their jurisdiction. One dose of Men-C-C vaccine is recommended for all children at 12 to 23 months of age, regardless of any doses given during the first year of life. Men-C-C is routinely given at 12 months of age if they have not previously been immunized as infants or toddlers. In addition, immunization with 4CMenB vaccine may be considered on an individual basis, depending on individual preferences, regional serogroup B epidemiology and strain susceptibility.

## Healthy adolescents and young adults (12 to 24 years of age)
Either Men-C-C or Men-C-ACYW vaccine, depending on local epidemiology and programmatic considerations, is recommended for adolescents, routinely at 12 years of age and young adults, even if they have previously been vaccinated as an infant or toddler. In addition, 4CMenB or MenB-fHBP vaccine may be considered on an individual basis, depending on the individual preferences, regional serogroup B epidemiology and strain susceptibility.

# Catch-up and accelerated schedules

# Healthy infants and children (2 to 11 years of age)
One dose of Men-C-C vaccine is recommended in unimmunized children less than 5 years of age. One dose of Men-C-C vaccine may be considered for children 5 to 11 years of age if they have not previously been immunized as infants or toddlers. Immunization with 4CMenB vaccine (2 years of age and older) or MenB-fHBP (10 years of age and older) may be considered on an individual basis, depending on individual preferences, regional serogroup B epidemiology and strain susceptibility.

# High risk individuals
Meningococcal vaccines are recommended for individuals with underlying medical conditions and those who are at increased risk of exposure to meningococcal disease.

## Underlying medical conditions
Individuals with increased risk of meningococcal disease because of underlying medical conditions include the following:
- persons with functional or anatomic asplenia, sickle cell disease, or combined T and B cell immunodeficiencies
- persons with congenital complement, properdin, factor D or primary antibody deficiencies
- persons with acquired complement deficiency due to receipt of the terminal complement inhibitor eculizumab (SolirisTM)
- individuals with HIV, especially if it is congenitally acquired

## Increased risk of exposure
Individuals at increased risk of exposure to meningococcal disease include the following:
- travellers to areas with high rates of endemic meningococcal disease or transmission, including travellers to the meningitis belt of sub-Saharan Africa and pilgrims to the Hajj in Mecca, Saudi Arabia. Refer to  section for additional information.
- research, industrial and clinical laboratory personnel who are potentially routinely exposed to *N. meningitidis*. Refer to  section for additional information.
- military personnel during recruit training and on certain deployments. Refer to  section for additional information.
Meningococcal vaccine is also recommended for most close contacts of a case of IMD and for outbreak control, if the disease is caused by a serogroup contained in the vaccine. Refer to  and  for additional information.

## Age considerations for choice of vaccine for high risk groups

### 2 to 23 months of age
Based on available published data in this age group, Men-C-ACWY-CRM should be used because it has been found to be safe and immunogenic. Routine meningococcal C conjugate vaccine does not need to be administered in addition to Men-C-ACWY-CRM. For toddlers and children who may be at increased high risk of IMD caused by serogroup B, 4CMenB vaccine should also be offered.

### 24 months to 9 years of age
Any of the Men-C-ACYW vaccines may be used. For individuals who are at high risk of IMD caused by serogroup B, 4CMenB vaccine should also be offered.

### 10 years of age and older
Any of the Men-C-ACYW vaccines may be used. For individuals who are at high risk of IMD caused by serogroup B, 4CMenB or MenB-fHBP vaccine should also be offered.
Refer,  for recommended vaccination for certain travellers.
At high risk due to underlying medical conditions: refer to 
A serogroup B meningococcal vaccine should be offered for the active immunization of individuals with underlying medical conditions that would put them at higher risk of meningococcal disease. 4CMenB vaccine is indicated for immunization of high risk individuals greater than or equal to two months of age; MenB-fHBP vaccine may be considered as an option for use in high-risk individuals 10 years of age and older.
A booster dose should be given every 3 to 5 years if vaccinated at 6 years of age or younger and every 5 years for those vaccinated at 7 years of age and older.
Depending on the age at which immunization is initiated, the manufacturer of 4CMenB recommends three doses for infants who begin primary immunization between the ages of 2 and 5 months, and two doses when the first dose is received between ages of 6 and 11 months.
Men-C-ACYW vaccines may be given a minimum of 4 weeks apart if accelerated immunization needed.
Serogroup B Meningococcal vaccines are not authorized for use in those 26 years of age and older and Men-C-ACYW vaccines are not authorized for use in those 56 years of age and older; however, based on limited evidence and expert opinion their use is considered appropriate above these authorized ages.

# Booster doses and re-immunization
Circulating antibodies are considered necessary to protect an individual against IMD. Re-vaccination is recommended as follows:
- For individuals at high risk of developing meningococcal disease due to underlying medical conditions, refer to . Re-vaccination with Men-C-ACYW is recommended every 3 to 5 years for those vaccinated at 6 years of age and younger and every 5 years for those vaccinated at 7 years of age and older.
- When travelling to areas where meningococcal vaccine is recommended or required, re-vaccination with Men-C-ACYW is recommended every 3 to 5 years for those vaccinated at 6 years of age and younger, and every 5 years for those vaccinated at 7 years of age and older. Previously vaccinated travellers are advised to check requirements for re-vaccination with meningococcal vaccines prior to travel to the Hajj as more frequent vaccination may be required (refer to  and ).
- For military personnel who remain at risk due to travel or overcrowded conditions, a booster dose of Men-C-ACYW is recommended every 5 years if at ongoing risk.
- At the time of exposure for contacts of a case of IMD in some circumstances. Refer to .
- During a community outbreak of IMD in some circumstances. Refer to .
- For all laboratory personnel who are potentially routinely exposed to *N. meningitidis.- Booster doses of Men-C-ACYW should be given at routine 5 year intervals for those laboratory workers who remain at ongoing risk of exposure. Refer to .
People previously vaccinated with a polysaccharide meningococcal vaccine should be re-vaccinated with the appropriate conjugate or serogroup B meningococcal vaccine if they remain at ongoing risk for meningococcal disease. Conjugated meningococcal vaccine should be given at least 6 months following vaccination with polysaccharide meningococcal vaccine.

# Post-exposure management

## Contacts of cases
Close contacts of individuals with meningococcal infections have an increased risk of developing IMD; this risk is greatest for household contacts. The increased risk of disease for household contacts persists for up to 1 year after disease in the index case and beyond any protection from antibiotic chemoprophylaxis. In general, this prolonged risk is not seen in contacts who do not have ongoing exposure.
Chemoprophylaxis should be offered to all persons having close contact with a case of IMD from 7 days before onset of symptoms in the case to 24 hours after onset of effective treatment in the case, regardless of their immunization status. Refer to the PHAC  for information about chemoprophylaxis in the management of close contacts of individuals with meningococcal infection.
Vaccination or re-vaccination of certain close contacts should be considered in addition to chemoprophylaxis when the serogroup is vaccine preventable, as it may further reduce the risk of subsequent meningococcal disease.

### Close contacts requiring chemoprophylaxis and consideration for immunoprophylaxis
The following individuals (regardless of immunization status) should receive chemoprophylaxis and, if the meningococcal serogroup identified in the case of IMD is vaccine preventable, should also be considered for immunoprophylaxis:
- Household contacts of a case of IMD
- Persons who share sleeping arrangements with a case of IMD
- Persons who have direct nose or mouth contamination with oral or nasal secretions of a case of IMD (e.g., kissing on the mouth, shared cigarettes, sharing bottles)
- Children and staff in contact with a case of IMD in child care or nursery school facilities

### Re-vaccination criteria for those previously vaccinated against IMD
The following provides criteria for the re-vaccination of previously vaccinated close contacts when the index case has a vaccine preventable IMD serogroup or there is a vaccine preventable outbreak of IMD:
- Those previously vaccinated with a serogroup that differs from the index case or outbreak strain should be vaccinated immediately with the appropriate vaccine (as outlined in );
- Those previously vaccinated with a serogroup that is the same as the index case or outbreak strain should be re-vaccinated with the appropriate vaccine (as outlined in );
	+ If they were less than 1 year of age at last meningococcal vaccination and more than 4 weeks has passed since their last meningococcal vaccine;
	+ If they have an underlying medical condition that puts them at risk for meningococcal disease and more than 4 weeks has passed since their last meningococcal vaccine;
	+ If more than a year has passed since their last meningococcal vaccine, if they were not less than 1 year of age at the time of their last meningococcal vaccination and if they have no underlying medical condition that puts them at risk for meningococcal disease.

### Close contacts requiring chemoprophylaxis only
The following individuals should receive chemoprophylaxis only, immunoprophylaxis is not necessary:
- Health care workers who have had intensive unprotected contact (without wearing a mask) with infected patients (i.e., intubating, resuscitating or closely examining the oropharynx).
- Airline passengers sitting immediately on either side of the case (but not across the aisle) when the total time spent aboard the aircraft was at least 8 hours.
- Close contacts of a case of IMD due to serogroups not present in meningococcal vaccines, or when the serogroup in the index case has not been determined.
- Previously vaccinated close contacts who do not meet the criteria for re-vaccination as outline above.

# Outbreak control

## Outbreaks of meningococcal disease
Consultation with public health officials, experts in communicable disease, or both is important in the assessment and control of meningococcal disease outbreaks. Outbreaks may be controlled by the use of a conjugate meningococcal vaccine. The type of vaccine to use in an outbreak is dependent on the serogroup causing the outbreak and the age of those being vaccinated as outlined in . Re-vaccination criteria of previously vaccinated individuals are outlined above in 
 OR
- Men-C-ACYW
Previously vaccinated:* If previously vaccinated with only Men C-C, give Men-C-ACYW-CRM as for unvaccinated persons, regardless of when Men-C-C was previously given
- If previously vaccinated with Men-C-ACYW, then re-vaccinate with one dose of Men-C-ACYW-CRM if at least 4 weeks since last dose of Men-C-ACYW vaccine; then complete series
Previously vaccinated:* If previously vaccinated with only Men C-C, give Men-C-ACYW-CRM as for unvaccinated persons, regardless of when Men-C-C was previously given
- If previously vaccinated with Men-C-ACYW at less than 1 year of age OR person is at high risk for IMD due to underlying medical conditions, then re-vaccinate with one dose of Men-C-ACYW-CRM if at least 4 weeks since last dose of Men-C-ACYW; otherwise re-vaccinate with one dose of Men-C-ACYW-CRM if at least 1 year since last dose of Men-C-ACYW
Previously vaccinated:* If previously vaccinated with only Men C-C, give Men-C-ACYW as for unvaccinated persons, regardless of when Men-C-C was previously given
- If previously vaccinated with Men-C-ACYW at less than 1 year of age OR person is at high risk for IMD due to underlying medical conditions, then re-vaccinate with one dose of Men-C-ACYW if at least 4 weeks since last dose of Men-C-ACYW; otherwise re-vaccinate if at least 1 year since last dose
At high risk due to underlying medical conditions - refer to 
In general, a minimum four week interval is recommended between doses of conjugate meningococcal vaccines; however, in an outbreak or to manage a close contact of a case of IMD, the second dose of conjugate meningococcal vaccine may be given as soon as indicated to provide protection to a close contact who is unvaccinated for the implicated serogroup.
Individuals at high risk due to underlying medical conditions routinely need two doses of Men-C-ACYW
Only for outbreak control of IMD caused by serogroup B strains that are predicted to be susceptible to the vaccine. Consultation with public health officials, experts in communicable disease or both is required for optimal management of meningococcal disease outbreaks.
During an outbreak, the vaccine should be provided as soon as possible after the identification of a serogroup B strain that is predicted to be susceptible to the vaccine.
Vaccination of specific populations

# Persons with inadequate immunization records
Children and adults lacking adequate documentation of immunization should be considered unimmunized and started on an immunization schedule appropriate for their age and risk factors. Conjugate meningococcal vaccine, as appropriate for age, may be given regardless of possible previous receipt of the vaccine, as adverse events associated with repeated immunization have not been demonstrated. Refer to  in Part 3 for additional general information.

# Pregnancy and breastfeeding
Conjugate and serogroup B meningococcal vaccines have not been studied in pregnancy or breastfeeding. However, there is no theoretical reason to suspect that adverse events will occur and, in circumstances in which the benefits outweigh the risks (i.e. in high risk individuals due to exposure or underlying medical conditions), the use of conjugate and serogroup B meningococcal vaccines in pregnancy and breastfeeding may be considered. Refer to  in Part 3 for additional information.

# Infants born prematurely
Premature infants in stable clinical condition should be immunized with conjugate meningococcal vaccine at the same chronological age and according to the same schedule as full-term infants. Infants born prematurely, especially those weighing less than 1,500 grams at birth are at higher risk of apnea and bradycardia following vaccination. Hospitalized premature infants should have continuous cardiac and respiratory monitoring for 48 hours after their first immunization. Refer to  in Part 3 for additional general information.

# Persons/residents in health care institutions
Residents of long-term care facilities should receive meningococcal vaccine as appropriate for their risk factors. Refer to  in Part 3 for additional general information.

# Persons with chronic diseases

## Asplenia
Two doses of Men-C-ACYW vaccine are recommended for persons with anatomic or functional asplenia, including sickle cell disease. When elective splenectomy is planned, all recommended vaccines should ideally be completed at least 2 weeks before surgery; if only one dose can be given before surgery, the second dose should be given 8 weeks after the first dose, with a minimum interval of 4 weeks. In the case of an emergency splenectomy, two doses of vaccine should ideally be given beginning 2 weeks after surgery but can be given earlier, before discharge, if the person might not return for vaccination after discharge. Persons one year of age and older with asplenia who have not received Men-C-ACYW vaccine should receive two doses administered 8 weeks apart, with a minimum interval of 4 weeks. In addition, 4CMenB or MenB-fHBP vaccine should be offered. Periodic booster doses with Men-C-ACYW vaccine are also recommended.

# Immunocompromised persons
Quadrivalent conjugate meningococcal vaccine provided with 4CMenB or MenB-fHBP vaccine is recommended for certain high risk individuals as outlined under  above. People with conditions requiring the receipt of the terminal complement inhibitor eculizumab (SolirisTM) should be vaccinated at least two weeks prior to receiving the first dose of eculizumab. When considering immunization of an immunocompromised person, consultation with the individual's attending physician may be of assistance in addition to the guidance provided below. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised.

# Travellers
Travellers should be vaccinated with Men-C-ACYW vaccine alone or in combination with 4CMenB or MenB-fHBP vaccine, depending on the risk of meningococcal disease in the area of travel. Men-C-C vaccine alone is not appropriate for protection of travellers, as it does not protect against serogroup A, which is endemic in selected regions of the world (e.g. sub-Saharan Africa), or serogroup W disease. 4CMenB or MenB-fHBP vaccine is recommended for individuals travelling to an area with a hyperendemic strain or an outbreak that is known to be caused by a serotype B that can be prevented by the vaccine. Current  is available from the WHO.
Proof of meningococcal immunization may be required by certain countries. For example, Saudi Arabia requires proof of immunization with a quadrivalent (ACYW) vaccine for travellers with the purpose of Umrah or pilgrimage (Hajj) or for seasonal work. Refer to the Saudi Arabia Ministry of Health website for information regarding vaccination requirements. Refer to  in Part 3 for additional information.
Travellers to the Hajj should check recommendations for re-vaccination at:  as more frequent re-vaccination may be required.
A booster dose of Men-C-ACYW should be given every 3 to 5 years if vaccinated at 6 years of age or younger and every 5 years for those vaccinated at 7 years of age and older.
Depending on the age at which immunization is initiated, the manufacturer of 4CMenB recommends two or three primary doses and a booster (2 + 1 schedule or 3 + 1 schedule) when the first dose is received between the ages of 2 and 5 months, and two primary doses and a booster (2 + 1 schedule) when the first dose is received between ages of 6 and 11 months. The booster dose should be administered in the second year of life.
Men-C-ACYW-CRM may be given a minimum of 4 weeks apart if accelerated immunization is needed.
Serogroup B Meningococcal vaccines are not authorized for use in those 26 years of age and older and Men-C-ACYW vaccines are not authorized for use in those 56 years of age and older; however, based on limited evidence and expert opinion their use is considered appropriate above these authorized ages.

# Persons new to Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals. Review of meningococcal vaccination status is particularly important for persons from areas of the world where sickle cell disease is present as persons with sickle cell disease are at risk of serious meningococcal infections. In many countries outside of Canada, conjugate meningococcal vaccines are in limited use. Information on  can be found on the  website. Refer to  in Part 3 for additional general information.

# Workers

## Laboratory workers
Research, industrial and clinical laboratory personnel who are potentially routinely exposed to *N. meningitidis- should be offered one dose of Men-C-ACYW vaccine and two doses of 4CMenB vaccine given at least 4 weeks apart or two doses of MenB-fHBP vaccine given at least 6 months apart. Re-vaccination is generally recommended every 5 years for Men-C-ACYW. There are currently no booster dose recommendations for serogroup B meningococcal vaccines. Routine infection control precautions should be practiced at all times to minimize the risk of exposure in laboratory workers and post-exposure prophylaxis should be offered after recognized exposures. Refer to  for additional information.

## Health care workers (HCW)
Nosocomial transmission of IMD is very uncommon. HCW are considered as close contacts only if they have had intensive, unprotected contact (without wearing a mask) with infected patients (e.g., intubating, resuscitating or closely examining the oropharynx). It is recommended that HCW use barrier precautions to avoid direct contact with respiratory secretions of patients with meningococcal disease until the patient has completed 24 hours of effective antibiotic therapy, according to provincial and territorial communicable disease control guidelines.
There is no evidence to recommend routine meningococcal immunization of HCW since the risk period for acquisition ends when contact with an untreated patient terminates, and antibiotic chemoprophylaxis should be sufficient in the high-risk situation described above.

## Military personnel
Military personnel may be at increased risk of IMD when accommodated in close quarters or through deployment to endemic or epidemic countries.
Serologic testing
Serologic testing is not recommended before or after receiving meningococcal vaccine.
Administration practices

# Dose and route of administration

## Dose
Each dose of meningococcal vaccine is 0.5 mL.

## Route of administration
Conjugate and serogroup B meningococcal vaccines should be administered intramuscularly (IM). Refer to  in Part 1 for additional information.

# Interchangeability of vaccines
There are no published data regarding the interchangeability of Men-C-C vaccines, but the vaccines have been safely interchanged without a noticeable decrease in efficacy. When possible, the infant series should be completed with the same vaccine. Either Men-C-ACYW vaccine may be used for re-vaccination, regardless of which meningococcal vaccine was used for initial vaccination. The serogroup B meningococcal vaccines are not interchangeable as they contain different antigens and there are no published studies on the immunogenicity resulting from a vaccination series combining the two products. Therefore, the same vaccine product should be used for all doses in a vaccination series. If, in a person with an incomplete vaccination series, it is unknown what vaccine product they initially received, the initial dose(s) should be discounted and the vaccination series repeated using the same vaccine product for all doses in the new, repeated series.

# Simultaneous administration with other vaccines
Men-C-C and 4CMenB vaccine may be administered concomitantly with routine childhood vaccines, and Men-C-ACYW vaccine may be administered concomitantly with adolescent and adult age appropriate vaccines. MenB-fHBP can be given concomitantly with quadrivalent human papillomavirus vaccine; meningococcal serogroup A, C, Y, W conjugate vaccine; and tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed. The concomitant administration of MenB-fHBP has not been studied with other vaccines.
Men-C-ACYW-CRM can be administered with routine paediatric vaccines; however, further studies are needed with regard to concomitant administration with pneumococcal 13-valent conjugate vaccine. Co-administration of Men-C-ACYW-CRM and combined tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) may result in a lower immune response to the pertussis antigens than when Tdap vaccine is given alone; however, the clinical significance of this is unknown. Tdap vaccine given one month after Men-C-ACYW-CRM induces the strongest immunologic response to pertussis antigens.
If vaccines are to be administered concomitantly with another vaccine, a separate injection site and a different syringe must be used for each injection.
Storage requirements
Menactra, NeisVac-C Vaccine, Trumenba: Store in a refrigerator at +2C to +8C. Do not freeze.
BEXSERO, MENJUGATE Liquid, MENVEO, NIMENRIX: Store in a refrigerator at +2C to +8C. Do not freeze. Protect from light.
Safety and adverse events

# Common and local adverse events

## Conjugate meningococcal vaccines

### Men-C-ACYW vaccines
Injection site reactions occur in up to 59% of vaccinees. Fever is reported in up to 5% of recipients and systemic reactions, such as headache and malaise, are reported in up to 60% of recipients.

### Men-C-C vaccines
Mild reactions, including injection site reactions (redness, tenderness, and swelling), occur in up to 50% of vaccine recipients. Irritability occurs in up to 80% of infants and fever in up to 9% when other vaccines were administered. Headaches and malaise occur in up to 10% of older children and adults. These reactions last no more than a few days.

## Serogroup B Meningococcal vaccines

### 4CMenB vaccine
Solicited local and systemic reactions have been commonly reported in clinical trials and include injection site tenderness, induration, sleepiness and irritability. Higher rates of fever have been observed with simultaneous administration of 4CMenB vaccine and routine infant vaccines; therefore, routine prophylactic administration of acetaminophen or separating 4CMenB vaccination from routine vaccination schedule has been proposed for preventing fever in infants and children up to three years of age.

### MenB-fHBP vaccine
Solicited local and systemic reactions have been commonly reported in clinical trials and include injection site tenderness, induration and irritability.

# Less common and serious or severe adverse events
Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association.

# Guidance on reporting adverse events following immunization (AEFI)
To ensure the ongoing safety of vaccines in Canada, reporting of AEFIs by vaccine providers and other clinicians is critical, and in some jurisdictions, reporting is mandatory under the law.
Vaccine providers are asked to report AEFIs, through  officials, and to check for specific AEFI reporting requirements in their province or territory. In general, any serious or unexpected adverse event felt to be temporally related to vaccination should be reported.
For additional information about AEFI reporting, please refer to . For general vaccine safety information, refer to  in Part 2.

# Contraindications and precautions
Meningococcal vaccine is contraindicated in persons with a history of anaphylaxis after previous administration of the vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container. Refer to Table 1 in  in Part 1 for lists of all vaccines available for use in Canada and their contents.
There are very few individuals who cannot receive meningococcal vaccines. In situations of suspected hypersensitivity or non-anaphylactic allergy to vaccine components, investigation is indicated, which may involve immunization in a controlled setting. Consultation with an allergist is advised.
Administration of meningococcal vaccine should be postponed in persons with moderate or severe acute illness. Persons with minor acute illness, with or without fever, may be vaccinated.