Menactra: Package Insert and Label Information (Page 3 of 3)

14.3 Concomitant Vaccine Administration

MMRV (or MMR + V) or PCV7

In a US, active-controlled trial, 1179 children received Menactra 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 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 participants with available sera, pneumococcal opsonophagocytic assay GMT data were consistent with IgG GMC data.

Td Vaccine

In a double-blind, randomized, controlled trial, 1021 participants aged 11 through 17 years received Td vaccine and Menactra concomitantly (N=509), or Td vaccine followed one month later by Menactra (N=512). Sera were obtained approximately 28 days after each respective vaccination. The proportions of participants with a 4-fold or greater increase in SBA-BR titer to meningococcal Serogroups C, Y and W-135 were higher when Menactra was given concomitantly with Td vaccine (86%-96%) than when Menactra was given one month following Td vaccine (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 concomitantly (N=469), or Typhim Vi followed one month later by Menactra (N=476). Sera were obtained approximately 28 days after each respective vaccination. The antibody responses to Menactra and to Typhim Vi components were similar in both study groups.

DAPTACEL and IPV

In a randomized, parallel group, US multi-center clinical trial conducted in children 4 through 6 years of age, Menactra was administered as follows: 30 days after concomitant DTaP (DAPTACEL® , Sanofi Pasteur Limited) + IPV (IPOL ® , Sanofi Pasteur SA) [Group A]; concomitantly with DAPTACEL followed 30 days later by IPV [Group B]; concomitantly with IPV followed 30 days later by DAPTACEL [Group C]. Sera were obtained approximately 30 days after each respective vaccination [see Clinical Trials Experience (6.1)].

When Menactra was administered 30 days after DAPTACEL (and IPV) [Group A], significantly lower SBA-H GMTs to all 4 meningococcal serogroups were observed compared to Menactra (and IPV) administered 30 days prior to DAPTACEL [Group C]. When Menactra was administered concomitantly with DAPTACEL [Group B], SBA-H GMTs to meningococcal serogroups A, C, and W-135 were non-inferior to those observed after Menactra (and IPV) [Group C]. The non-inferiority criterion was marginally missed for meningococcal serogroup Y. Non-inferiority of SBA-H GMTs following concomitant administration of Menactra and DAPTACEL compared to those after concomitant Menactra and IPV was concluded if the upper limit of the 2-sided 95% CI of (GMTGroup C divided by GMTGroup B ) computed separately for each of the serogroups was <2.

The respective SBA-H GMTs and proportion (%) of Group A, B, and C study participants achieving an SBA-H titer of ≥1:8 are displayed in Table 8.

Table 8: Bactericidal Antibody Responses * 30 Days Following Menactra Administered Alone or Concomitantly with DAPTACEL or IPV
Vaccines administered at Visit 1 and 30 days later at Visit 2
Visit 1Visit 2 Group ADAPTACEL + IPVMenactra Group BMenactra + DAPTACELIPV Group CMenactra + IPVDAPTACEL
(N=250) (N=238) (N=121)
Serogroup (95% CI) (95% CI) (95% CI)
*
Serum bactericidal assay with an exogenous human complement (SBA-H) source.
N=Total number of the subjects in the study population per group.
95% CIs for the proportions are calculated based on the Clopper-Pearson Exact method and normal approximation for that of the GMTs.
§
The proportion of participants achieving an SBA-H titer of at least 1:8, 30 days after Menactra.
A % ≥1:8§ 49.6 (41.0; 58.3) 67.2 (58.4; 75.1) 64.4 (54.4; 73.6)
GMT 6.7 (5.7; 8.0) 10.8 (8.7; 13.3) 10.4 (8.1; 13.3)
C % ≥1:8§ 20.3 (13.9; 28.0) 50.4 (41.5; 59.2) 50.5 (40.5; 60.5)
GMT 3.3 (2.7; 3.9) 8.1 (6.3; 10.5) 7.8 (5.8; 10.7)
Y %≥1:8§ 44.2 (35.8; 52.9) 80.2 (72.3; 86.6) 88.5 (80.7; 93.9)
GMT 6.5 (5.1; 8.2) 18.1 (14.2; 22.9) 26.2 (20.0; 34.4)
W-135 %≥1:8§ 55.1 (46.4; 63.5) 87.8 (80.9; 92.9) 82.7 (74.0; 89.4)
GMT 8.4 (6.7; 10.6) 22.8 (18.5; 28.1) 21.7 (16.6; 28.4)

When Menactra was administered concomitantly with DAPTACEL, antibody responses to three of the pertussis antigens (pertussis toxin, filamentous hemagglutinin, and pertactin) (GMCs), tetanus toxin (% participants with antibody concentrations ≥1.0 IU/mL), and diphtheria toxin (% participants with antibody concentrations ≥1.0 IU/mL) were non-inferior to those observed after DAPTACEL and IPV. The pertussis anti-fimbriae GMCs were marginally lower when Menactra and DAPTACEL were administered concomitantly.

15 REFERENCES

1
CDC. Guillain-Barré syndrome among recipients of Menactra® meningococcal conjugate vaccine-United States, June 2005-September 2006. MMWR Morb Mortal Wkly Rep 2006;55:1120-1124. Erratum in: MMWR Morb Mortal Wkly Rep 2006;55(43):1177.
2
Harvard Medical School/Harvard Pilgrim Health Care Institute. Risk of Guillain-Barré Syndrome Following Meningococcal Conjugate (MCV4) Vaccination. Final Study Report, Revised March 11, 2010.
3
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.
4
Watson RG, et al. The specific hapten of group C (group IIa) meningococcus. I. Preparation and immunological behavior. J Immunol 1958;81:331-336.
5
Mueller JH, et al. Production of diphtheria toxin of high potency (100 Lf) on a reproducible medium. J Immunol 1941;40:21-32.
6
Mäkelä PH, et al. Evolution of conjugate vaccines. Expert Rev Vaccines 2002;1:399-410.
7
Goldschneider I, et al. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med 1969;129:1307-1326.
8
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;4:156-167.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

  • Single-dose vial, 0.5 mL (NDC 49281-589-58). Supplied as a package of 5 vials (NDC 49281-589-05).

16.2 Storage and Handling

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Frozen/previously frozen product should not be used. Do not use after the expiration date.

Discard any unused portion.

17 PATIENT COUNSELING INFORMATION

Vaccine Information Statements are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization to the patient, parent, or guardian. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

Inform the patients, parents or guardians about:

  • Potential benefits and risks of immunization with Menactra.
  • Potential for adverse reactions that have been temporally associated with administration of Menactra or other vaccines containing similar components.
  • Reporting any adverse reactions to their healthcare provider.
  • The Sanofi Pasteur Inc. Pregnancy Registry, as appropriate [see Pregnancy (8.1)].

Menactra, DAPTACEL, Menomune, IPOL, and Typhim Vi are registered trademarks of Sanofi, its affiliates and subsidiaries.
Prevnar is a registered trademark of Wyeth LLC.
ProQuad and VAQTA are registered trademarks of Merck & Co., Inc.

Manufactured by:
Sanofi Pasteur Inc.
Swiftwater, PA 18370 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

NDC 49281-589-58
single-dose
(0.5 mL)

Meningococcal
(Groups A, C, Y and
W-135) Polysaccharide
Diphtheria Toxoid
Conjugate Vaccine
Menactra®
Rx only
Mfd by: Sanofi Pasteur Inc.

Menactra® MCV4

NDC 49281-589-58

Rx only

Mfd by: Sanofi Pasteur Inc.

(L) XXXXXX

7507

(L) XXXXXX

(E) DDMMMYY

PRINCIPAL DISPLAY PANEL -- 0.5 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 Vial Package

NDC 49281-589-05

MCV4

Meningococcal (Groups A, C, Y and
W-135) Polysaccharide Diphtheria
Toxoid Conjugate VaccineMenactra®

5 single-dose vials

Rx only

For 9 months through 55 years of age

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 5 Vial Package
(click image for full-size original)
MENACTRA neisseria meningitidis group a capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide diphtheria toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide diphtheria toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide diphtheria toxoid conjugate antigen injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-589
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE ANTIGEN 4 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
formaldehyde
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-589-05 5 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (49281-589-58)
1 NDC:49281-589-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (49281-589-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125089 01/14/2005
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Inc. 086723285 MANUFACTURE

Revised: 01/2021 Sanofi Pasteur Inc.

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