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

14.3 Concomitantly Administered Vaccines

In Study 006 conducted in the US (Table 1), the immune responses to Prevnar 13 were measured one month after the third dose. Non-inferiority criteria were met for GMCs to 12 of the 13 serotype antigens in Prevnar 13 for participants who received VAXELIS relative to Control vaccines. For serotype 6B, the non-inferiority criterion was not met (lower bound of 2-sided 95% CI for GMC ratio [VAXELIS group/Control vaccines group] is 0.64, which is below the non-inferiority criterion >0.67).

15 REFERENCES

1
Stratton K, Ford A, Rusch E, Clayton EW, eds. Institute of Medicine (IOM). Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press. 2011.
2
Goepp JG, Hohenboken M, Almeido-Hill J, Santosham M. Persistent urinary antigen excretion in infants vaccinated with Haemophilus influenzae type b capsular polysaccharide conjugated with outer membrane protein from Neisseria meningitidis. Pediatr Infect Dis J 1992;11(1):2–5.
3
Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174; 1991. p. 7–11.
4
Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271–7.
5
Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1971;63:211–20.
6
Department of Health and Human Services, Food and Drug Administration. Biological products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Federal Register 1985;50(240):51002–117.
7
Tiwari TSP, Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, and Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: WB Saunders; 2013:153–66.
8
Roper M, Wassilak SGF, Tiwari TSP, Orenstein WA. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 6th ed. Philadelphia, PA: WB Saunders; 2013. p. 746–72.
9
Sutter RW, et al. Defining surrogate serologic tests with respect to predicting protective vaccine efficacy: Poliovirus vaccination. In: Williams JC, et al. eds. Combined vaccines and simultaneous administration. Current issues and perspectives. New York, NY: The New York Academy of Sciences. 1995:289–99.
10
Robbins, J. B., et al: Quantitative measurement of ‘natural’ and immunization-induced Haemophilus influenzae type b capsular polysaccharide antibodies. Pediatr Res 1973;7(3):103–10.
11
Kayhty H, et al. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 1983;147:1100.
12
Anderson P. The protective level of serum antibodies to the capsular polysaccharide of Haemophilus influenzae type b. J Infect Dis 1984;149:1034.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

VAXELIS is supplied in a single-dose vial (NDC 63361-243-58) in packages of 10 vials (NDC 63361-243-10).

The vial stopper is not made with natural rubber latex.

16.2 Storage and Handling

VAXELIS should be stored at 2°C to 8°C (36°F to 46°F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Inform the parent or guardian of the following:

  • The potential benefits and risks of immunization with VAXELIS.
  • The common adverse reactions that have occurred following administration of VAXELIS or other vaccines containing similar ingredients.
  • Other adverse reactions can occur. Call healthcare provider with any adverse reactions of concern.

Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.

Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada
for:
MSP Vaccine Company
Swiftwater PA 18370 USA

Distributed by:
Merck Sharp & Dohme Corp.
A subsidiary of Merck & Co., Inc.
Whitehouse Station NJ 08889 USA
and Sanofi Pasteur Inc.
Swiftwater PA 18370 USA

VAXELIS is a trademark of MSP Vaccine Company. The trademarks depicted herein are owned by their respective companies.

R3-0420 USA

PRINCIPAL DISPLAY PANEL — 0.5 mL Vial Label

DTaP-IPV-Hib-HepB
NDC 63361-243-58

6 wks — 4 yrs
Single-dose
(0.5 mL) IM

Diphtheria and Tetanus
Toxoids and Acellular Pertussis,
Inactivated Poliovirus,
Haemophilus b Conjugate
and Hepatitis B VaccineVaxelis™

Rx only

Mfd by: Sanofi Pasteur Limited

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

PRINCIPAL DISPLAY PANEL — 10 Vial Package

NDC 63361-243-10

DTaP-IPV-Hib-HepB
10 single-dose vials

Diphtheria and Tetanus Toxoids
and Acellular Pertussis,
Inactivated Poliovirus,
Haemophilus b Conjugate
and Hepatitis B Vaccine

Vaxelis™

For children 6 weeks through 4 years of age
Rx only

MERCK SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 10 Vial Package
(click image for full-size original)
VAXELIS diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis b vaccine injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:63361-243
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 15 [Lf] in 0.5 mL
CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) (CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)) CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 5 [Lf] in 0.5 mL
BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) (BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)) BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED) 20 ug in 0.5 mL
BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (BORDETELLA PERTUSSIS PERTACTIN ANTIGEN) BORDETELLA PERTUSSIS PERTACTIN ANTIGEN 3 ug in 0.5 mL
BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN (BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN) BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN 5 ug in 0.5 mL
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 29 [D'ag'U] in 0.5 mL
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 7 [D'ag'U] in 0.5 mL
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 26 [D'ag'U] in 0.5 mL
HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN (HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN) HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN 10 ug in 0.5 mL
HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN (HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN) HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN 3 ug in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
POLYSORBATE 80 28 ug in 0.5 mL
FORMALDEHYDE 14 ug in 0.5 mL
GLUTARAL 50 ng in 0.5 mL
ALBUMIN BOVINE 50 ng in 0.5 mL
NEOMYCIN 5 ng in 0.5 mL
POLYMYXIN B SULFATE 25 ng in 0.5 mL
STREPTOMYCIN 200 ng in 0.5 mL
AMMONIUM THIOCYANATE 0.125 ug in 0.5 mL
GI-6207 0.1 ug in 0.5 mL
WATER
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63361-243-10 10 VIAL, SINGLE-DOSE in 1 PACKAGE contains a VIAL, SINGLE-DOSE (63361-243-58)
1 NDC:63361-243-58 0.5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the PACKAGE (63361-243-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125563 12/21/2018
Labeler — MSP Vaccine Company (079352454)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Limited 208206623 MANUFACTURE (63361-243)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur SA 578763542 MANUFACTURE (63361-243)
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 002387926 MANUFACTURE (63361-243)

Revised: 05/2020 MSP Vaccine Company

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