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Indication: VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis,
Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a
vaccine indicated for active immunization to prevent diphtheria, tetanus,
pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus
influenzae type b (Hib). VAXELIS is approved for use as a 3-dose series in
children 6 weeks through 4 years of age (prior to the 5th birthday).


 * Prescribing Information
 * Patient Information

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 * For Healthcare Professionals Only

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 * For Healthcare Professionals Only

 * Important Safety Information
 * Prescribing Information
 * Patient Information

 * Immunogenicity
 * Safety
 * VAXELIS Schedule & Dosing
 * Why Transition?
 * FAQs
 * Resources for VAXELIS

 * Important Safety Information

 * Immunogenicity
 * Safety
 * VAXELIS Schedule & Dosing
 * Why Transition?
 * FAQs
 * Resources for VAXELIS






WHEN 6 WORK TOGETHER AS 1, YOU CAN EXPERIENCE THE BENEFITS OF FEWER SHOTS WITH
VAXELIS1,2,3,4

When 6 work together as 1,

you can experience the benefits of

fewer shots with VAXELIS1,2,3,4

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A combination of tried and tested antigens1,2,5,6

See the immunogenicity data for VAXELIS >

May reduce shot burden1,2,3,4

See the immunization schedule for VAXELIS >

May help improve efficiencies and reduce administrative tasks7

See how VAXELIS may simplify some aspects of vaccine-related tasks1,2,3,4,7 >

VAXELIS is available to order

To order directly:

VaccineShoppe.com

For authorized distributors:

VaxelisContract.com


Important Safety Information
•Do not administer VAXELIS to anyone with a history of severe allergic reaction
to a previous dose of VAXELIS, any ingredient of VAXELIS, or any other
diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine, inactivated
poliovirus vaccine, hepatitis B vaccine, or Hib vaccine. •Do not administer
VAXELIS to anyone with a history of severe allergic reaction to a previous dose
of VAXELIS, any ingredient of VAXELIS, or any other diphtheria toxoid, •Do not
administer VAXELIS to anyone with a history of encephalopathy within 7 days of a
pertussis-containing vaccine with no other identifiable cause. •Do not
administer VAXELIS to anyone with a history of progressive neurologic disorder
until a treatment regimen has been established and the condition has stabilized.

VAXELIS is available to order

To order directly:

VaccineShoppe.com

For authorized distributors:

VaxelisContract.com

Back to Top
Important Safety Information
 * Do not administer VAXELIS to anyone with a history of severe allergic
   reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any
   other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine,
   inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.
 * Do not administer VAXELIS to anyone with a history of encephalopathy within 7
   days of a pertussis-containing vaccine with no other identifiable cause.
 * Do not administer VAXELIS to anyone with a history of progressive neurologic
   disorder until a treatment regimen has been established and the condition has
   stabilized.
 * Carefully consider benefits and risks before administering VAXELIS to persons
   with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode
   (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours
   after a previous pertussis-containing vaccine; and/or seizures within 3 days
   after a previous pertussis-containing vaccine.
 * If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior
   vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may
   be increased following VAXELIS.
 * Apnea following intramuscular vaccination has been observed in some infants
   born prematurely. Consider the individual infant’s medical status and
   potential benefits and possible risks of intramuscular vaccination in
   deciding when to administer VAXELIS to an infant born prematurely.
 * Vaccination with VAXELIS may not protect all individuals.
 * The solicited adverse reactions 0-5 days following any dose were irritability
   (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%),
   injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C
   (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
 * The 3-dose immunization series consists of a 0.5 mL intramuscular injection,
   administered at 2, 4, and 6 months of age.
 * A 3-dose series of VAXELIS does not constitute a primary immunization series
   against pertussis; an additional dose of pertussis-containing vaccine is
   needed to complete the primary series.

Before administering VAXELIS, please read the Prescribing Information. The
Patient Information also is available.


 
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Copyright © 2022 MSP Vaccine Company. All rights reserved.

This site is intended for health care professionals in the United States, its
territories, and Puerto Rico. US-VAX-00621 03/22



IMPORTANT SAFETY INFORMATION

×
 * Do not administer VAXELIS to anyone with a history of severe allergic
   reaction to a previous dose of VAXELIS, any ingredient of VAXELIS, or any
   other diphtheria toxoid, tetanus toxoid, pertussis-containing vaccine,
   inactivated poliovirus vaccine, hepatitis B vaccine, or Hib vaccine.
 * Do not administer VAXELIS to anyone with a history of encephalopathy within 7
   days of a pertussis-containing vaccine with no other identifiable cause.
 * Do not administer VAXELIS to anyone with a history of progressive neurologic
   disorder until a treatment regimen has been established and the condition has
   stabilized.
 * Carefully consider benefits and risks before administering VAXELIS to persons
   with a history of: fever ≥40.5°C (≥105°F), hypotonic-hyporesponsive episode
   (HHE), or persistent, inconsolable crying lasting ≥3 hours within 48 hours
   after a previous pertussis-containing vaccine; and/or seizures within 3 days
   after a previous pertussis-containing vaccine.
 * If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior
   vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may
   be increased following VAXELIS.
 * Apnea following intramuscular vaccination has been observed in some infants
   born prematurely. Consider the individual infant’s medical status and
   potential benefits and possible risks of intramuscular vaccination in
   deciding when to administer VAXELIS to an infant born prematurely.
 * Vaccination with VAXELIS may not protect all individuals.
 * The solicited adverse reactions 0-5 days following any dose were irritability
   (≥55%), crying (≥45%), injection site pain (≥44%), somnolence (≥40%),
   injection site erythema (≥25%), decreased appetite (≥23%), fever ≥38.0°C
   (≥19%), injection site swelling (≥18%), and vomiting (≥9%).
 * The 3-dose immunization series consists of a 0.5 mL intramuscular injection,
   administered at 2, 4, and 6 months of age.
 * A 3-dose series of VAXELIS does not constitute a primary immunization series
   against pertussis; an additional dose of pertussis-containing vaccine is
   needed to complete the primary series.

Before administering VAXELIS, please read the Prescribing Information. The
Patient Information also is available.

REFERENCE

×
1. Pentacel. Prescribing Information. NDC No. 49281-510-05. Sanofi Pasteur;
2022.

REFERENCE

×
2. Pentacel. Prescribing Information. NDC No. 49281-511-05. Sanofi Pasteur;
2022.

REFERENCE

×
3.

PEDIARIX. Prescribing Information. GlaxoSmithKIine; 2019.

REFERENCE

×
4. Centers for Disease Control and Prevention. Recommended child and adolescent
immunization schedule for ages 18 years or younger, United States, 2022.
Accessed August 9, 2022.
https://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf

REFERENCE

×
5. Oliver SE, Moore KL. Licensure of a diphtheria and tetanus toxoids and
acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b
conjugate, and hepatitis B vaccine, and guidance for use in infants. MMWR Morb
Mortal Wkly Rep. 2020;69(5):136–139. doi:10.15585/mmwr.mm6905a5

REFERENCE

×
6. Marshall GS, Adams GL, Leonardi ML, et al. Immunogenicity, safety, and
tolerability of a hexavalent vaccine in infants. Pediatrics.
2015;136(2):e323-e332. doi:10.1542/peds.2014-4102

REFERENCE

×
7. Pellissier JM, Coplan PM, Jackson LA, May JE. The effect of additional shots
on the vaccine administration process: results of a time-motion study in 2
settings. Am J Manag Care. 2000;6(9):1038-1044

REFERENCE

×
8. Block SL, Klein NP, Sarpong K, et al. Lot-to-lot consistency, safety,
tolerability, and immunogenicity of an investigational hexavalent vaccine in US
infants. Pediatr Infect Dis J. 2017;36(2):202-208.
doi:10.1097/INF.0000000000001405

REFERENCE

×
9.

RECOMBIVAX HB. Prescribing Information. Merck & Co., Inc.; 2020.

REFERENCE

×
10.

Liquid PedvaxHIB. Prescribing Information. Merck & Co., Inc; 2020.

REFERENCE

×
11.

Data available on request from Merck & Co., Inc., Professional Services-DAP,
WPl-27, PO Box 4, West Point, PA 19486-0004. Please specify information package
US-VAX-00622.

REFERENCE

×
12.

Centers for Disease Control and Prevention. General best practice guidelines for
immunization. Accessed August 11, 2022.
https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/index.html

REFERENCE

×
13.

De Coster I, Fournie X, Faure C, et al. Assessment of preparation time with
fully-liquid versus non-fully liquid paediatric hexavalent vaccines. A time and
motion study. Vaccine. 2015;33(32):3976 -3982. doi:10.1016/j.vaccine.2015.06.030

REFERENCE

×
14.

Ciarametaro M, Bradshaw SE, Guiglotto J, Hahn B, Meier G. Hidden efficiencies:
making completion of the pediatric vaccine schedule more efficient for
physicians. Medicine (Baltimore). 2015;94(4):e357.
doi:10.1097/MD.0000000000000357

REFERENCE

×
15.

Kennedy A, Lavail K, Nowak G, Basket M, Landry S. Confidence about vaccines in
the United States: understanding parents’ perceptions. Health Aff (Millwood).
2011 Jun;30(6):1151-9. doi:10.1377/hlthaff.2011.0396

REFERENCE

×
16.

Sanofi Pasteur. Product Catalog, Vaccines & Biologics, VAXELIS, 1 carton of 10
prefilled syringes. VaccineShoppe.com. Accessed August 23, 2022.
https://www.vaccineshoppe.com/us/vsh/en/USO/Product-Catalog/Vaccines-%26-biologics/Vaxelis%E2%84%A2/p/243-15

REFERENCE

×
17.

Sanofi Pasteur. Product Catalog, Vaccines & Biologics, VAXELIS, 1 carton 10
vials. VaccineShoppe.com. Accessed August 23, 2022.
https://www.vaccineshoppe.com/us/vsh/en/USD/Product-Catalog/Vaccines-%26-biologics/Vaxelis%E2%84%A2/p/243-10

REFERENCE

×
18.

Sanofi Pasteur. Product Catalog, Vaccines & Biologics, Pentacel. Accessed August
11, 2022.
https://www.vaccineshoppe.com/us/vsh/en/USD/Product-Catalog/Vaccines-%26-biologics/Pentacel%C2%AE/p/511-05

REFERENCE

×
19.

GlaxoSmithKline. PEDIARIX pre-filled syringe ordering information. Accessed
August 11, 2022.
https://www.gskdirect.com/gsk/en/USD/RootCategory/Vaccines%28non-flu%29/PEDIARIX-PFS1DOSE-0-5ML-NONDL-10S-LM/p/58160081152?pro-from=product-list

REFERENCE

×
20.

Kurosky SK, Davis KL, Krishnarajah G. Effect of combination vaccines on
completion and compliance of childhood vaccinations in the United States. Hum
Vaccin Immunother. 2017;13(11):2494-2502. doi:10.1080/21645515.2017.1362515

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