Vaccine Information: MenQuadfi (Page 3 of 3)

14.2 Booster

Immunogenicity of a booster dose of MenQuadfi compared to a booster dose of Menactra was evaluated in Study 5 (NCT02752906). The study-enrolled participants 15 years of age and older who had received a primary dose of Menveo or Menactra 4 to 10 years previously.

Immune non-inferiority, based on seroresponse rates, was demonstrated for MenQuadfi as compared to Menactra for all four serogroups.

For a description of study design and number of participants, see section 6.1 Booster Vaccination Study. The primary immunogenicity endpoint was hSBA seroresponse to each serogroup 30 days following booster vaccination with MenQuadfi or Menactra given to participants who received a prior dose of Menveo or Menactra 4 to 10 years ago. Seroresponse was defined as the proportion of participants with an hSBA pre-vaccination titer < 1:8 who achieved a post-vaccination titer ≥ 1:16, or pre-vaccination titer ≥ 1:8 who achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The other endpoints included the proportions of participants with post-vaccination hSBA ≥1:8 and the hSBA GMTs for each serogroup. These endpoints were also evaluated at 6 days post vaccination in a subset.

Seroresponse rates at Day 30 following booster vaccination with MenQuadfi were 92.2% for serogroup A, 97.1% for serogroup C, 98.2% for serogroup W, and 97.4% for serogroup Y, as compared to 87.1% for serogroup A, 91.8% for serogroup C, 90.7% for serogroup W, and 95.6% for serogroup Y, following booster vaccination with Menactra. At Day 6, following booster vaccination with MenQuadfi, seroresponse rates were 72.7%, 83.6%, 94.5%, and 90.9% for serogroups A, C, W, and Y, respectively.

The hSBA GMTs were 173, 334, 499, and 302 for serogroups A, C, W, and Y at Day 6, and 497, 2618, 1747, and 2070, respectively, for the 4 serogroups at Day 30 following booster dose of MenQuadfi.

Overall, similar seroresponse rates were observed for those participants who received booster vaccination with Menactra.

14.3 Immunogenicity of Concomitantly Administered Vaccines

Concomitant administration of MenQuadfi with Tdap and HPV in adolescents 10 through 17 years was evaluated in Study 2 (NCT02199691). In this randomized study, 505 participants received MenQuadfi alone, 403 received MenQuadfi coadministered with Tdap and HPV, 300 received Tdap and HPV alone. A fourth group received Menveo alone (N=507).

No evidence of interference in hSBA seroresponse rates was observed when MenQuadfi was coadministered with Tdap and HPV. Antibody responses to HPV, and to the tetanus and diphtheria antigens were similar when Tdap and HPV were administered with and without MenQuadfi. Anti-pertussis GMC responses were non-inferior for the pertussis toxoid antigen, but did not meet non-inferiority for the FHA, PRN, and FIM antigens. The clinical relevance of the diminished responses to the pertussis antigens is unknown.

16 HOW SUPPLIED/STORAGE AND HANDLING

MenQuadfi is supplied in a single-dose vial (NDC 49281-590-58), in packages of 5 vials (NDC 49281-590-05).

The vial stopper is not made with natural rubber latex.

Store at 2°C to 8°C (35°F to 46°F). Do not freeze. Do not use vaccine that has been frozen. Do not use after expiration date.

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 MenQuadfi.
  • Potential for adverse reactions that have been temporally associated with administration of MenQuadfi 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) ].

MenQuadfi is a trademark of Sanofi Pasteur Inc.
Menactra, Adacel and Menomune are registered trademarks of Sanofi, its affiliates and/or its subsidiaries.
Menveo is a registered trademark of GlaxoSmithKline Biologicals S.A.
Gardasil is a registered trademark of Merck Sharp & Dohme Corp.

Manufactured by:
Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

© 2020, Sanofi Pasteur Inc. — All rights reserved
R0-0420

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

NDC 49281-590-58

Meningococcal
(Groups A, C, Y, W)
Conjugate Vaccine
MenQuadfi™
Mfd by: Sanofi Pasteur Inc.

single-
dose(0.5 mL)

Rx only

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

PRINCIPAL DISPLAY PANEL — 5 Vial Carton

NDC 49281-590-05

Meningococcal
(Groups A, C, Y, W)
Conjugate Vaccine

MenQuadfi™

For 2 years of age and older

5 single-
dosevials

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 5 Vial Carton
(click image for full-size original)
MENQUADFI neisseria meningitidis group a capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group c capsular polysaccharide tetanus toxoid conjugate antigen, neisseria meningitidis group y capsular polysaccharide tetanus toxoid conjugate antigen, and neisseria meningitidis group w-135 capsular polysaccharide tetanus toxoid conjugate antigen injection, solution
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-590
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP A CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP C CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP Y CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN (NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN) NEISSERIA MENINGITIDIS GROUP W-135 CAPSULAR POLYSACCHARIDE TETANUS TOXOID CONJUGATE ANTIGEN 10 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 3.35 mg in 0.5 mL
SODIUM ACETATE ANHYDROUS 1.23 mg in 0.5 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-590-05 5 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (49281-590-58)
1 NDC:49281-590-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (49281-590-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125701 04/23/2020
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Inc. 086723285 MANUFACTURE

Revised: 04/2020 Sanofi Pasteur Inc.

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