Vaccine Information: VAXELIS (Page 4 of 5)

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

Single-dose vial (NDC 63361-243-58) in packages of 10 vials (NDC 63361-243-10).

Single-dose, prefilled syringe with Luer lock connection and a tip cap, without needle, 0.5 mL (NDC 63361-243-88). Supplied as package of 10 (NDC 63361-243-15).

The vial stopper, syringe plunger stopper, and syringe tip cap are 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. Protect from light. Do not use after expiration date shown on the label. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient 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 LLC
A subsidiary of Merck & Co., Inc.
Rahway NJ 07065 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.

R9-1022 USA

Patient Information
VAXELIS® (pronounced “vak-sel-lis”)(Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine)
Before your child gets VAXELIS, read this document and be sure you understand all of the information. Keep this document, you may need to read it again. If you have questions or side effects, ask your child’s healthcare provider. This information does not take the place of talking about VAXELIS with your child’s healthcare provider.
What is VAXELIS?
VAXELIS is a vaccine given to protect your child from getting diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, Hib (Haemophilus influenzae type b), and hepatitis B.
Your child cannot get any of these diseases from VAXELIS.
VAXELIS may not completely protect your child from these diseases.
Who should not get VAXELIS?
Your child should not get VAXELIS, if your child:
  • is allergic to any of the ingredients.
  • had an allergic reaction to any prior shot for diphtheria, tetanus, pertussis, polio, Hib, or hepatitis B.
  • had a serious reaction affecting their brain and nervous system after a whooping cough shot.
  • has a brain and nerve illness that is getting worse.
Before your child gets VAXELIS, tell your healthcare provider if your child:
  • had problems with any shots for these diseases.
  • is taking steroids, getting treatment for cancer, or has another problem that weakens the immune system.
How is VAXELIS given?
  • VAXELIS is given to children from 6 weeks through 4 years of age (up to 5th birthday).
  • Your child will need 3 shots:
    • one shot at 2 months old, and
    • one shot at 4 months old, and
    • one shot at 6 months old
  • If your child misses a shot of VAXELIS, your healthcare provider may suggest a catch-up schedule.
  • Your child may get VAXELIS at the same time they get other vaccines.
What are the most common side effects of VAXELIS?
  • pain, redness, or swelling where the shot was given
  • fever (100.4°F or higher)
  • crying more than usual
  • eating less than usual
  • fussy more than usual
  • sleepy more than usual
  • throwing up
There may be other side effects that are not listed. If your child has any side effects that worry you or seem to get worse, tell your child’s healthcare provider right away.
You may report any side effects directly to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov , or contact Sanofi Pasteur Inc., at 1-800-822-2463 (1-800-VACCINE).
To learn more about VAXELIS, ask your healthcare provider. You can also find the Full Prescribing Information written for doctors at www.fda.gov/media/119465/download.
What is in VAXELIS?
  • Active ingredients: inactivated bacteria of diphtheria, tetanus, pertussis, Hib, and inactivated hepatitis B and polio viruses. The bacteria and viruses in VAXELIS are not alive and do not cause disease.
  • Other ingredients: aluminum salts, polysorbate 80, glutaraldehyde, formaldehyde, bovine serum albumin, neomycin, streptomycin, polymyxin B, ammonium thiocyanate, yeast protein, and water.
  • VAXELIS does not have any preservatives in it.
  • VAXELIS vial stopper, syringe plunger stopper, and syringe tip cap do not contain natural rubber latex.
Manufactured by: Sanofi Pasteur Limited Toronto Ontario Canada for: MSP Vaccine Company Swiftwater PA 18370 USA. Distributed by: Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. Rahway NJ 07065 USA, and by 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.Initial Approval: 23 October 2020R2-1022

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 Vaccine Vaxelis®

Rx only

Mfd by: Sanofi Pasteur Limited

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

PRINCIPAL DISPLAY PANEL — 0.5 mL 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

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

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