MENINGOCOCCAL A CONJUGATE VACCINE Lyophilized
MenAfriVac ™

DESCRIPTION
MenAfriVac (Meningococcal A Conjugate vaccine) is a lyophilized vaccine of purified meningococcal A polysaccharide covalently bound to tetanus toxoid (TT), which acts as a carrier protein. The vaccine consists of purified group-specific bacterial polysaccharide from Neisseria meningitidis group A.
The TT is prepared by extraction, ammonium sulfate purification, and formalin inactivation of the toxin from cultures of Clostridium tetani grown in a modified Mueller and Miller medium. The vaccine meets the requirements of WHO when tested by the methods outlined in WHO, TRS 962 (2011).
The MenAfriVac is provided as a 1/10 doses presentation consisting of a vial and an ampoule. Each vial contains a lyophilised powder of meningococcal group A polysaccharide conjugated to tetanus toxoid protein and excipients. Each ampoule contains the diluent with aluminium phosphate as adjuvant (the amount does not exceed 1.25 mg per single human dose) and thiomersal (0.01%) as preservative. The diluent is a white slightly opaque homogeneous suspension presented in a 0.5/5 ml ampoule.
The lyophilised conjugate is reconstituted just before use with the contents of one ampoule of diluent to obtain 1/10 doses of the final vaccine in a white homogeneous suspension. A single dose of vaccine is equivalent to 0.5 ml of the reconstituted suspension.
Each dose of 0.5 ml contains: Meningococcal A polysaccharide 10 mcg, TT (carrier protein) 10 to 33 mcg and excipients: mannitol, sucrose and Tris (hydroxymethyl) aminomethane.
 

INDICATIONS
MenAfriVac is indicated for active immunization against invasive meningococcal disease caused by meningococcus group A only. It does not protect against other forms of invasive disease including purulent meningitis caused by other meningococcus groups (such as Groups B, C, W135, Y), by Haemophilus influenzae type b, by Streptococcus pneumoniae, etc. It also does not protect against meningitis caused by other organisms such as viruses, fungi, mycobacteria etc.
MenAfriVac is recommended for routine immunization of children beginning at 1 year of age, adolescents and adults up to 29 years of age, for the prevention of invasive disease caused by Neisseria meningitidis Group A. Children from 12 months of age, adolescents and adults up to 29 years of age should receive a single 0.5 mL dose. The safety and immunogenicity of a booster dose has been evaluated in children 2-3 years of age old yet the need for revaccination has not been established.
Subjects who have previously received a Meningococcal A polysaccharide containing vaccine can be vaccinated with MenAfriVac. It is particularly recommended for subjects at risk, for example those living in or visiting areas where the disease is epidemic or highly endemic. It is also recommended for subjects living in closed communities and close contacts of patients with disease caused by meningococcus Group A, persons with laboratory or industrial exposure to N. meningitidis aerosols.


DOSAGE AND ADMINISTRATION
The vaccine is for intramuscular use only. MenAfriVac (Meningococcal A Conjugate vaccine) should be administered by deep intramuscular injection, preferably in the deltoid muscle. The vaccine must not be administered subcutaneously or intravenously, and must not be mixed with other vaccines in the same syringe.
The lyophilizate must be reconstituted by adding the entire contents of the supplied container of diluent to the vaccine vial, by using a sterile needle and sterile syringe. The vaccine pellet should be completely dissolved in the diluent. The vaccine should be inspected visually for any foreign particulate matter prior to administration. In the event of it being observed, the vaccine must be discarded. A new sterile needle and sterile syringe must be used for each injection. Once the vaccine has been reconstituted, it should be used the same day (preferably immediately but by no means beyond six (6) hours after reconstitution), and only then if the vial has been maintained between +2°C and +8°C and protected from sunlight. Any opened container remaining at the end of a session should be discarded.

ADVERSE REACTIONS
MenAfriVac has shown adverse reactions during clinical trials in the 4 days following immunization, such as injection site tenderness in 2% to 30%, induration in less or equal to 2%, fever (body temperature ≥ 38°C) in 2% to 7%, and diarrhea in less or equal to 13% of children and adults 1 to 29 years of age. Other systemic adverse reactions consisted principally of irritability in less or equal to 12% of children 1 to 10 years of age or headache in less or equal to 11% of children and adults 11 to 29 years of age while other reactions such as vomiting (1 to 29 years of age); loss of appetite and lethargy (1 to 10 years of age) were reported in less or equal to 10% of the vaccine recipients and fatigue, myalgia, arthralgia (11 to 29 years of age) in less or equal to 1%. The frequencies of reactions were similar to those observed with licensed MenACWY polysaccharide vaccine, licensed MenAC polysaccharide vaccine or licensed Hib-TT vaccine with the exception of tenderness. All adverse reactions following immunization were transient and resolved without sequelae.

The vaccine did not cause any immediate adverse reactions nor beyond 4 days postimmunization. It also did not cause any delayed onset reactions.

CONTRA-INDICATIONS
The vaccine must not be administered to subjects with known hypersensitivity to any component of the product or to subjects having shown hypersensitivity after previous administration of the vaccine. It should not be used in subjects with acute infectious diseases and/or ongoing progressive (acute or chronic) illnesses. Any body temperature ≥ 38°C or active infection is reason to delay immunization. Pregnant women should not be immunized since effects of vaccine on the fetus are unknown. Lactating women also should not be given the vaccine since it is not known whether the vaccine is excreted in human milk. Administration of the vaccine to subject with impaired immune responses may not induce an effective response.

PRECAUTIONS AND WARNINGS
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available. Since anaphylactic, anaphylactoid or other allergic type reactions are theoretically possible following administration of MenAfriVac, 1:1000 adrenaline and other drugs such as hydrocortisone injection and chlorpheniramine maleate injection should be available for immediate treatment if such reaction occurs. For this reason the vaccinee should remain under medical supervision for 30 minutes after immunization.
Though MenAfriVac has shown boosting of anti-tetanus antibody concentrations; it does not substitute TT booster doses.
No safety or efficacy data are available for the administration of MenAfriVac to individuals leaving with HIV infection. Practitioners should evaluate the potential risks and benefits of administering the vaccine in these populations, considering the fact that subjects living with HIV infection are at increased risk for meningococcal disease.
Before administration of each dose of MenAfriVac, the subject, or if a child, the child's parent or guardian, should be questioned about possible adverse events after the previous dose or after a previous dose of a TT-containing vaccine.
There is no evidence that MenAfriVac can cause meningococcal meningitis. Clinical alertness to the possibility of co-incidental meningitis should be maintained.

DRUG INTERACTIONS
Following administration of the vaccine to immune suppressed persons or persons receiving chronic immunosuppressive therapy, an adequate immunologic response may not be obtained.
There is no data yet on whether MenAfriVac can be concomitantly given with other vaccines.


PREGNANCY AND LACTATION
Adequate human data on use during pregnancy or lactation, and adequate animal reproduction studies are not available. Meningococcal A Conjugate vaccine is not recommended in pregnancy unless there is a definite risk of group A meningococcal disease. Lactating women also should not be given the vaccine since it is not known whether the vaccine is excreted in human milk.


SHELF LIFE
The expiry date of the vaccine is indicated on the label and packaging.


STORAGE
MenAfriVac should be stored and transported between 2-8ºC. Protect from light. The diluent should be stored at 25°C. It is recommended to protect the reconstituted vaccine from direct sunlight. Do not exceed the expiry date stated on the external packaging. Immediately prior to reconstitution the vaccine is stable and can be used when exposed upto 40ºC for period of 4 days provided the vaccine has not reached its expiry date and the vaccine vial monitor has not reached the discard point.


Instructions for use/handling
MenAfriVac (Meningococcal A Conjugate vaccine) is presented as a white vaccine pellet in a vial, with sterile diluent in a separate container. The diluent and reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspects prior to administration. In the event of either being observed, discard the diluent or reconstituted vaccine. The vaccine must be reconstituted by adding the entire contents of the supplied container of diluent (0.5/5 ml to 1/10 dose vials) to the vial containing the pellet, using a sterile syringe and a sterile needle. Only the diluent provided with the vaccine must be used for reconstitution. After the addition of the diluent to the pellet, the mixture should be well shaken- until the pellet is completely dissolved in the diluent. A new sterile syringe and sterile needle should be used to administer each dose of the vaccine. After reconstitution, the vaccine should be injected promptly.


PRESENTATION
1 dose vial plus diluent (0.5 ml)
10 dose vial plus diluent (5 ml)


THE VACCINE VIAL MONITOR (Optional)

Vaccine Vial Monitors (VVMs) are part of the label on MenAfriVac (Meningococcal A Conjugate vaccine) supplied through Serum Institute of India Ltd. The colour dot which appears on the label of the vial is a VVM. This is a time-temperature sensitive dot that provides an indication of the cumulative heat to which the vial has been exposed. It warns the end user when exposure to heat is likely to have degraded the vaccine beyond an acceptable level.
The interpretation of the VVM is simple. Focus on the central square. Its colour will change progressively. As long as the colour of this square is lighter than the colour of the ring, then the vaccine can be used. As soon as the colour of the central square is the same colour as the ring or of a darker colour than the ring, then the vial should be discarded. However, it is well known that there are no correlates of protection for live attenuated influenza vaccines.