MENINGOCOCCAL A CONJUGATE VACCINE Lyophilized
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.
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,
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
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
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
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
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.
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.
The expiry date of the vaccine is indicated on the label and
MenAfriVac should be stored and transported between 2-8șC.
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 40șC 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.
1 dose vial plus diluent (0.5 ml)
10 dose vial plus diluent (5 ml)
THE VACCINE VIAL MONITOR (Optional)
Inner square lighter than outer
If the expiry date has not passed,
USE the vaccine.
At a later time, inner square still lighter than
If the expiry date has not passed, USE the vaccine.
Inner square matches colour of outer circle.
DO NOT use the vaccine.
Beyond the discard point:
Inner square darker than outer ring.
DO NOT use the vaccine.
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.
MOST IMPORTANT WARNING
Please ensure that the vaccine
is administered by intramuscular route only. In rare cases
anaphylactic shock may occur in susceptible individual and
for such emergency please keep handy 1:1000 adrenaline
injection ready to be injected intramuscularly or
subcutaneously. For treatment of severe anaphylaxis the
initial dose of adrenaline is 0.1 - 0.5 mg (0.1 - 0.5 ml
of 1:1000 injection) given s/c or i/m. Single dose should
not exceed 1 mg (1 ml). For infants and children the
recommended dose of adrenaline is 0.01 mg/kg (0.01 ml/kg
of 1:1000 injection). Single paediatric dose should not
exceed 0.5 mg (0.5 ml). This will help in tackling the
anaphylactic shock/reaction effectively.
The mainstay in the treatment
of severe anaphylaxis is the prompt use of adrenaline,
which can be lifesaving. It should be used at the first
suspicion of anaphylaxis. As with the use of all vaccines
the vaccines should remain under observation for not less
than 30 minutes for possibility of occurrence of rapid
allergic reactions. Hydrocortisone and antihistaminics
should also be available in addition to supportive
measures such as oxygen inhalation.