14.3.Concomitant Vaccine Administration
MMRV (or MMR+V) or PCV7

In a US, active-controlled trial, 1179 children received Menactra vaccine at 9 months and 12 months of age. At 12 months of age these children received Menactra concomitantly with MMRV (N=616), or MMR + V (N=48), or PCV7 (N=250). Another group of 12-month old children received MMRV + PCV7 (N=485). Sera were obtained approximately 30 days after the last vaccinations. Measles, mumps, rubella and varicella antibody responses among children who received Menactra vaccine and MMRV (or MMR and V) were comparable to corresponding antibody responses among children who received MMRV and PCV7.

When Menactra was given concomitantly with PCV7, the non-inferiority criteria for comparisons of pneumococcal IgG GMCs (upper limit of the two-sided 95% CI of the GMC ratio ≤2) were not met for 3 of 7 serotypes (4, 6B, 18C). In a subset of subjects with available sera, pneumococcal opsonophagocytic assay GMT data were consistent with IgG GMC data.

Td

In a double-blind, randomized, controlled trial, 1021 participants aged 11 through 17 years received Td and Menactra vaccines concomitantly (N=509), or Td followed one month later by Menactra vaccine (N=512). Sera were obtained approximately 28 days after each respective vaccination. The proportion of participants with a 4-fold or greater increase in SBA-BR titer to meningococcal Serogroups C, Y and W-135 was higher when Menactra vaccine was given concomitantly with Td (86-96%) than when Menactra vaccine was given one month following Td (65-91%). Anti-tetanus and anti-diphtheria antibody responses were similar in both study groups.

Typhim Vi

In a double-blind, randomized, controlled trial, 945 participants aged 18 through 55 years received Typhim Vi and Menactra vaccines concomitantly (N=469), or Typhim Vi vaccine followed one month later by Menactra vaccine (N=476). Sera were obtained approximately 28 days after each respective vaccination. The antibody responses to Menactra vaccine and to Typhim Vi vaccine components were similar in both study groups.

15.REFERENCES
1
CDC. Guillain-Barré Syndrome Among Recipients of Menactra® Meningococcal Conjugate Vaccine - United States, June 2005 - September 2006. MMWR 2006;55(41);1120-1124.
2
Mueller JH, et al. A Protein-Free Medium for Primary Isolation of the Gonococcus and Meningococcus. Proc Soc Exp Biol Med 1941;48:330-333.
3
Watson RG, et al. The specific hapten of group C (group IIa) meningococcus. I. Preparation and immunological behavior. J Immunol 1958;81:331-336.
4
Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 1941;40:21-32.
5
Mäkelä PH, et al. Evolution of conjugate vaccines. Expert Rev Vaccines 2002;1(3):399-410.
6
Goldschneider I, et al. Human immunity to the meningococcus. I. The Role of Humoral Antibodies. J Exp Med 1969;129:1307-1326.
7
Maslanka SE, et al. Standardization and a Multilaboratory Comparison of Neisseria meningitidis Serogroup A and C Serum Bactericidal Assays. Clin and Diag Lab Immunol 1997;156-167.
16.HOW SUPPLIED/STORAGE AND HANDLING
16.1.How Supplied
Vial, 1 Dose (5 vials per package). NDC 49281-589-05
16.2.Storage and Handling
Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Frozen/previou