Meningococcal Polysaccharide Group A/ Group C/ Group Y/ Group W-135/ Diphtheria Toxoid Conjugate Vaccine

Registered South African indications:

• Active immunisation for prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
• Control of meningococcal outbreaks
• Boost the serogroup C antibody response in subjects primed with a monovalent C conjugate vaccine

Contraindications
South African manufacturer recommendations

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to previous administration of the vaccine or a vaccine containing the same components
• Moderate or severe febrile and/or acute disease

International manufacturer recommendations

• Hypersensitivity to the active ingredients or any of its excipients
• Hypersensitivity to diphtheria toxoid
• Life-threatening reaction after previous administration of a vaccine containing similar components
• Acute severe febrile illness

Cautions
South African manufacturer recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Thrombocytopenia or bleeding disorders
• Immunosuppressed individuals (See additional prescribing points)
• Previous Guillain-Barré syndrome diagnosis
• Functional or anatomical asplenia
• Low-grade fever
• Coadminstration with other vaccines (See additional prescribing points)

International manufacturer recommendations

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Immunocompromised people
• Functional or anatomical asplenia
• Minor infection
• Familial complement deficiencies (for example, C3 or C5 deficiencies)
• Individuals receiving treatments that inhibit terminal complement activation (e.g. eculizumab)
• Thrombocytopenia
• Bleeding disorders
• Coadministration with anticoagulants

Forms avail. in SA and covered in this monograph: vac

South African manufacturer recommendations

Active immunisation for prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
Control of meningococcal outbreaks
Boost the serogroup C antibody response in subjects primed with a monovalent C conjugate vaccine

• IM: 0.5ml, as a single dose

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Administered in the anterolateral thigh or deltoid region depending on the recipient’s age and muscle mass 

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Do not administer by intravascular injection

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Avoid injecting the vaccine intradermally or subcutaneously since clinical studies have not been done to establish safety and efficacy of the vaccine using these routes of administration

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The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine is not to be used for treatment of meningococcal infections

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The vaccine should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. Do not use if the content appears otherwise

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Refer to national recommendations for high-risk groups

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Coadministration with other vaccines: See additional prescribing points

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International manufacturer recommendations

Active immunization for those at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease

• IM: 0.5ml, as a single dose

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  To ensure optimal antibody levels against all vaccine serogroups, the primary vaccination schedule with meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine should be completed one month prior to risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y

Paed. forms avail. in SA and covered in this monograph: vac

South African manufacturer recommendations

Active immunisation for prevention of invasive disease caused by Neisseria meningitidis serogroups A, C, Y and W-135
Control of meningococcal outbreaks
Boost the serogroup C antibody response in subjects primed with a monovalent C conjugate vaccine

Younger than 9 months

• No information available

Between 9-23 months

• IM: 0.5ml, given as 2-dose series, at least 3 months apart 

Older than 2 years

• See adult dosage 

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Administered in the anterolateral thigh or deltoid region depending on the recipient’s age and muscle mass

---

Do not administer by intravascular injection

---

Avoid injecting the vaccine intradermally or subcutaneously since clinical studies have not been done to establish safety and efficacy of the vaccine using these routes of administration

---

The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine is not to be used for treatment of meningococcal infections

---

The vaccine should be inspected visually for any particulate matter and/or variation of physical aspect prior to administration. Do not use if the content appears otherwise

---

Refer to national recommendations for high-risk groups

---

Coadministration with other vaccines: See additional prescribing points

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International manufacturer recommendations

Active immunization of those at risk of exposure to Neisseria meningitidis groups A, C, W-135 and Y, to prevent invasive disease

Younger than 2 years

• Not established for use

Older than 2 years

• See adult dosage

Pregnancy
South African manufacturer recommendations

• Caution
• Animal reproduction studies have not demonstrated a risk with respect to effects on pregnancy and embryo-foetal development, parturition and postnatal development. However, no studies have been performed in pregnant women and spontaneously reported post-marketing data on the use of this vaccine in pregnant women are limited
• The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine should be given to a pregnant woman only if clearly needed, such as during an outbreak or prior to necessary travel to an endemic area and only following an assessment of the risks and benefits
• Considering the severity of the meningococcal disease, pregnancy should not preclude vaccination when the risk/ benefit ratio of administering the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine is considered favourable

International manufacturer recommendations

• Caution
• Insufficient clinical data on exposed pregnancies are available
• In non-clinical studies, the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine had no direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Considering the severity of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y, pregnancy should not preclude vaccination when the risk of exposure is clearly defined

Breastfeeding

South African manufacturer recommendations

• Caution 
• It is not known whether the active substances included in the vaccine are excreted in human milk, but antibodies to the polysaccharides have been found to be transferred to the suckling offspring of mice
• Animal studies conducted in mice have not shown any harmful effect on the postnatal development of offspring exposed through breastfeeding to meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine-induced maternal antibodies. However, the effect on breastfed infants of the administration of the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine to their mothers has not been studied. The risks and benefits of vaccination should be assessed before making the decision to immunize a breastfeeding woman

International manufacturer recommendations 

• Caution 
• Although insufficient clinical data on the use of the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine during breastfeeding are available, it is unlikely that secreted antibodies in milk would be harmful when ingested by a breastfed infant
• Therefore, the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine may be used during breastfeeding

Fertility

South African manufacturer recommendations

• No information available

International manufacturer recommendations

• No effects on fertility were observed in female rabbits receiving the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine pre-mating and during pregancy

Renal Impairment

• Caution; no information available 

Hepatic Impairment

• Caution; no information available 

Elderly

South African manufacturer recommendations

• Caution; no information available 

International manufacturer recommendations

• Caution; no dose adjustment recommended 
  There are limited data in individuals aged 56-65 and there are no data in individuals aged >65 years

Porphyria Information

• Probably not porphyrinogenic (PNP) 

Drugs in Sport

• Permitted - No warnings 

Between 2-10 years

Central Nervous System Disorders

• Sleepiness
• Headache
• Irritability
• Malaise
• Tonic seizures
• Febrile seizures
• Syncope

Gastrointestinal Disorders

• Nausea and vomiting
• Diarrhea

Endocrine and Metabolic Disorders

• Eating disorder

Musculoskeletal Disorders

• Myalgia
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Rash
• Injection site reactions
  - Erythema
  - Induration
  - Pruritus
  - Pain
  - Cellulitis
  - Swelling (including extensive swelling of the injected limb)

Immune, Blood and Lymphatic System Disorders

• Chills
• Fever ≥38°C
• Lymphadenopathy
• Hypersensitivity (including anaphylaxis)

Sensory Disorders

• Vertigo

Between 11-65 years

Central Nervous System Disorders

• Headache 
• Dizziness 
• Malaise
• Tonic seizures
• Febrile seizures
• Syncope

Gastrointestinal Disorders

• Nausea 

Musculoskeletal Disorders

• Myalgia
• Arthralgia 

Skin and Subcutaneous Tissue Disorders

• Rash
• Injection site reactions
  - Pain
  - Erythema
  - Induration
  - Pruritus
  - Cellulitis
  - Swelling (including extensive swelling of the injected limb)

Immune, Blood and Lymphatic System Disorders

• Fever ≥38°C
• Chills
• Lymphadenopathy
• Hypersensitivity (including anaphylaxis)

Sensory Disorders

• Vertigo

• Immunosuppressants

None routine

Additional observations

• Monitor hypersensitivity and syncope (for at least 15mins following administration)

Traceability

• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded

Protection

• The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine will only protect against N meningitidis A, C, Y and W-135 serogroups and will not protect against any other microorganisms
• Although an antibody response to diphtheria toxoid may occur, the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine should not be considered as an immunising agent against diphtheria. No changes in the schedule for administering routine vaccines containing diphtheria toxoid are recommended

Anaphylactic reaction or serious adverse event

• Prior to administration of any dose of the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine, the person responsible for administration must take all precautions known for the prevention of allergic or any other reactions
• Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine. As a precautionary measure, epinephrine injection (1:1000) must be immediately available

Syncope

• Syncope (fainting) has been reported following vaccination with the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions

Immunosuppression

• The immunogenicity of the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine could be reduced by immunosuppressive treatment. In such cases, it is recommended to postpone the vaccination until the end of the immunosuppression. Nevertheless, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response might be limited
• If the vaccine is used in persons under immunosuppressive therapy, the expected immune response may not be obtained

Administration of the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine and DTaP

• In cases where the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine and DTaP vaccine are to be administered at 4 through 6 years of age, preference should be given to simultaneous administration of the 2 vaccines or administration of  the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine prior to DTaP vaccine

Coadministration with other vaccines

• In one clinical trial conducted in children 4-6 years of age, diphtheria and tetanus toxoid and acellular pertussis vaccine adsorbed (DTaP) and the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine had similar safety profiles and were well tolerated when coadministered or administered separately
• The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine can be administered concomitantly with typhoid Vi polysaccharide (Vi) or tetanus and diphtheria (Td) vaccines to adolescents and adults
• The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine can be administered with bivalent or quadrivalent human papillomavirus (HPV) vaccines
• The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine must not be mixed with any vaccine in the same syringe. Separate injection sites should be used in case of coadministration

Booster vaccination

• Long-term antibody persistence data following vaccination with the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine are available up to 5 years after vaccination
• The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine may be given as a booster dose in subjects who have previously received primary vaccination with this vaccine, other conjugated meningococcal vaccine or meningococcal unconjugated polysaccharide vaccine. The need for and timing of a booster dose in subjects previously vaccinated with the meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine is to be defined based on national recommendation

Special precautions for storage

• Store in a refrigerator (2-8°C). Do not freeze
• Keep the vials in the outer carton in order to protect from light

The meningococcal (groups A, C, Y and W-135) polysaccharide diphtheria toxoid conjugate vaccine's efficacy is inferred by inducing immunity through the production of bactericidal antibodies with bactericidal activity to the polysaccharide capsular components of Neisseria meningitidis serogroups A, C, Y and W-135.

Injection 0.5ml

• Menactra (Sanofi-Aventis) originator