Date shown reflects the date that the evidence was documented
2022-01-19
Meningococcal-Vaccine-Package-Insert-Menactra
"The diphtheria toxoid protein is purified by ammonium
sulfate fractionation and diafiltration. The derivatized polysaccharides are covalently linked to
diphtheria toxoid and purified by serial diafiltration. The four meningococcal components, present
as individual serogroup-specific glycoconjugates, compose the final formulated vaccine. No
preservative or adjuvant is added during manufacture. Each 0.5 mL dose may contain residual
amounts of formaldehyde of less than 2.66 mcg (0.000532%), by calculation. Potency of
Menactra is determined by quantifying the amount of each polysaccharide antigen that is
conjugated to diphtheria toxoid protein and the amount of unconjugated polysaccharide present.
Sanofi Pasteur Inc. 26 April 2018, v0.4
284 Menactra ® LE7186
Confidential/Proprietary Information
Page 26 of 43
Menactra is manufactured as a sterile, clear to slightly turbid liquid. Each 0.5 mL dose of vaccine
is formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg
each of meningococcal A, C, Y and W-135 polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier."
https://www.fda.gov/media/75619/download
https://www.fda.gov/media/90996/download
https://www.fda.gov/media/78514/download
Meningococcal-Vaccine-Package-Insert-Menactra
"The diphtheria toxoid protein is purified by ammonium
sulfate fractionation and diafiltration. The derivatized polysaccharides are covalently linked to
diphtheria toxoid and purified by serial diafiltration. The four meningococcal components, present
as individual serogroup-specific glycoconjugates, compose the final formulated vaccine. No
preservative or adjuvant is added during manufacture. Each 0.5 mL dose may contain residual
amounts of formaldehyde of less than 2.66 mcg (0.000532%), by calculation. Potency of
Menactra is determined by quantifying the amount of each polysaccharide antigen that is
conjugated to diphtheria toxoid protein and the amount of unconjugated polysaccharide present.
Sanofi Pasteur Inc. 26 April 2018, v0.4
284 Menactra ® LE7186
Confidential/Proprietary Information
Page 26 of 43
Menactra is manufactured as a sterile, clear to slightly turbid liquid. Each 0.5 mL dose of vaccine
is formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg
each of meningococcal A, C, Y and W-135 polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier."
https://www.fda.gov/media/75619/download
https://www.fda.gov/media/90996/download
https://www.fda.gov/media/78514/download