Labeling for Sanofi-Aventis' Menactra does not allow for superiority claims, FDA said in its Jan. 14 approval letter for the meningococcal conjugate vaccine.

"You should not make a comparative promotional claim or claim of superiority over other products unless you have submitted data to support such claims to us and had them approved," FDA's ¹ approval letter states.

Menactra was approved for protection against meningococcal disease in adults and adolescents 11-55 years old based on a demonstration of non-inferiority to Sanofi-Aventis' Menomune (² Also see "Sanofi-Aventis Eyes Expanded Menactra Indication Following Initial Approval" - Pink Sheet, 18 January, 2005.).

Menactra immunogenicity was demonstrated in two randomized, comparative, active-controlled trials, one in adolescents 11-18 years old and one in adults 18-55 years old, ³ labeling states.

In both the adolescent and adult trials, "the immune responses to Menactra vaccine and Menomune-A/C/Y/W-135 were similar for all four serogroups."

Menactra was also studied concomitantly with the Td vaccine (Tetanus and Diphtheria Toxoids Adsorbed For Adult Use) and the Typhim Vi vaccine.

"The proportion of participants with a 4-fold or greater rise in [Serum Bactericidal Assay with baby rabbit complement] titer was higher when Menactra vaccine was given concomitantly with Td than when Menactra vaccine was given one month following Td. The clinical relevance of this finding has not been fully evaluated," labeling states.

For Menactra plus Typhim Vi, immune responses for each vaccine when given concomitantly were similar to the responses when either vaccine was given alone.

In two primary safety studies comparing Menactra to Menomune, "serious adverse events reported within a 6-month time period following vaccination occurred at the same rate (1.3%) in the Menactra vaccine and Menomune-A/C/Y/W-135 vaccine groups. The events reported were consistent with events expected in healthy adolescent and adult populations," labeling states.

Menactra is administered intramuscularly in a single dose of 0.5 mL.

- Elizabeth Walker

Menactra Label Does Not Allow For Comparative Claims, FDA Says

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