Meningococcal

Menactra by Sanofi Pasteur (Meningococcal ACWY)

Captured 2022-12-06
Document Highlights

Initial U.S. Approval: 2005

Menactra is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135

Serious Adverse Events
9 months and at 12 months of age, SAEs occurred at a rate of 2.0% – 2.5%.
In children 2-10 years of age, SAEs occurred at a rate of 0.6%
In adolescents 11 through 18 years of age and adults 18 years through 55 years of age, SAEs occurred at a rate of 1.0%

Post-Marketing Experience
– Lymphadenopathy
– Hypersensitivity reactions such as anaphylaxis/anaphylactic reaction, wheezing, difficulty breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension
Guillain-Barré syndrome, paraesthesia, vasovagal syncope, dizziness, convulsion, facial palsy, acute disseminated encephalomyelitis, transverse myelitis
– Myalgia
– Large injection site reactions, extensive swelling of the injected limb (may be associated with erythema, warmth, tenderness or pain at the injection site).

Menactra is a sterile, intramuscularly administered vaccine that contains N meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein.

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.

Menactra has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility.

Comments

Menactra was not tested for safety in a placebo-controlled clinical trial.

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