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Home » Directories » FDA Approved Drugs » Menveo (meningitis vaccine)

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Menveo (meningitis vaccine)

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    General Information

    Menveo is a quadrivalent conjugated vaccine containing the Neisseria meningitidis serogroups A, C, Y and W-135. The presence of serum bactericidal antibodies protects against invasive meningococcal disease. Vaccination with Menveo leads to the production of bactericidal antibodies directed against the capsular polysaccharides of serogroups A, C, Y and W-135.

    Menveo is specifically indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. in persons 11 to 55 years of age.

    Menveo is supplied as a solution for intramuscular injection. Following reconstitution, Menveo should be administered as a single 0.5mL intramuscular injection, preferably into the deltoid muscle (upper arm).

    Clinical Results

    FDA Approval
    The FDA approval of Menveo was based on immunogenicity studies among subjects aged 11 to 55 years where efficay was inferred from the demonstration of non-inferiority of the serum bactericidal antibody responses to those of Menactra. A a randomized, multicenter, active controlled clinical trial conducted in the U.S. enrolled 3539 adolescent (11 to 18 years of age) and adult (19 to 55 years of age) subjects. The subjects were randomized to receive a dose of Menveo or Menactra. Sera were obtained both before vaccination and 28 days after vaccination. The primary effectiveness endpoints of the study were hSBA seroresponse rates to each serogroup 28 days after vaccination. The non-inferiority of Menveo to Menactra was demonstrated for all four serogroups using the primary endpoint (hSBA seroresponse) in both age populations.

    Side Effects

    Adverse events associated with the use of Menveo may include, but are not limited to, the following:

    • pain at the injection site
    • headache
    • myalgia
    • malaise
    • nausea

    Mechanism of Action

    Menveo is a quadrivalent conjugated vaccine containing the Neisseria meningitidis serogroups A, C, Y and W-135. The presence of serum bactericidal antibodies protects against invasive meningococcal disease. Vaccination with Menveo leads to the production of bactericidal antibodies directed against the capsular polysaccharides of serogroups A, C, Y and W-135.

    Additional Information

    For additional information regarding Menveo or invasive meningococcal disease, please visit the Menveo web page.

    Approval Date: 2010-02-01
    Date Created: 2010-03-22 12:00:00
    Company Name: Novartis
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