|
Indication |
Active immunization against invasive
meningococcal disease caused by Neisseria
meningitidis serogroup A, C, Y, and
W-135 |
|
Proprietary Name |
Menactra |
MENOMUNE-A/C/Y/W-135 |
Menveo |
|
Manufacturers |
sanofi pasteur |
sanofi pasteur |
Novartis |
|
Viability |
Inactivated |
Inactivated |
Inactivated
|
|
Approved Ages |
9 mos - 55 years |
2 years and older |
2-55 years |
|
Microorganism |
Neisseria meningitidis
serogroup A, C, Y and W-135 capsular
polysaccharide antigens |
Group-specific polysaccharide antigens from
Neisseria meningitidis, Group A, Group C,
Group Y and Group W-135 |
Meningococcal (Groups A, C, Y
and W-135) Oligosaccharide Diphtheria CRM197
Conjugate Vaccine
|
|
Dose |
0.5 mL |
0.5 mL |
0.5mL
|
|
Route |
Intramuscular |
Subcutaneous |
Intramuscular
|
|
Dose form |
Liquid |
Freeze-dried preparation |
Liquid
|
|
Appearance |
Clear to slightly turbid liquid. |
Clear, colorless liquid |
Clear, colorless liquid |
|
Concentration (per 0.5 mL) |
Meningococcal A, C, Y, - 4 mcg each
W-135 polysaccharides, 4 mcg
Diphtheria toxoid protein carrier, 48 mcg |
“Isolated product” from each of Groups A, C, Y
and W-135 in an isotonic sodium chloride
solution, 50 mcg each |
MenA oligosaccharide, 10 mcg
MenC, MenY
and MenW-135 oligosaccharides,5 mcg of each
CRM197 protein, 32.7 to 64.1
mcg
|
|
Preservatives |
None |
None in single dose vial
Thimerosal,
25 mcg
multidose vial |
None |
|
Adjuvants |
None |
None |
None |
|
Excipients |
Sodium phosphate buffered isotonic sodium
chloride solution |
Lactose, 2.5 to 5 mg |
Formaldehyde, residual
CY medium containing yeast
extracts and amino acids
|
|
Allergens |
Stopper of the vial contains dry natural rubber
latex |
Stopper of the vial contains dry natural rubber
latex |
|
|
Media |
Cultured on Mueller Hinton agar and grown in
Watson Scherp media |
Casamino acid medium and medium 199. N.
Meningitidis are cultivated with Mueller Hinton
agar1 and Watson Scherp2 media |
Franz Complete medium and
treated with formaldehyde
|
|
Packaging |
Vial, single dose and 5 single-dose package |
Vial, single dose + diluent
5 single dose + diluent packs
10-dose vial + dilent (not to be
used with jet injector) |
Vial of MenA lyophilized
conjugate component and a vial of MenCYW-135
liquid conjugate component (1 dose after
reconstitution). 5 doses (10 vials) per pack
|
|
Routine Storage |
2 to 8° C (35-46°
F)
Do not freeze |
2 to 8° C (35-46°
F)
Do not freeze |
2 to 8° C (35-46°
F)
Do not freeze |
|
PI Last updated |
November 2011 |
May 2012 |
March 2011 |
|
updated September 2012 |