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VAXELIS® OVERVIEW


VAXELIS (DTaP/IPV/Hib/Hep B) is a hexavalent vaccine indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive disease caused by Haemophilus influenzae type b (Hib). 1

VAXELIS contains 5 acellular pertussis components to effectively elicit seroprotection when used in a series of primary vaccinations. The Hib PRP-OMPC conjugate used in VAXELIS elicits earlier Hib protective responses than PRP conjugated to tetanus toxoid.2,3

VAXELIS is also the fully liquid hexavalent vaccine with a Luer-lock syringe, helping to reduce preparation time and potentially preparation errors.1, 4-6

Before you prescribe this vaccine, please refer to the Prescribing Information and Summary of Product Characteristics.

VAXELIS Prescribing information

View the Vaxelis SmPC

VAXELIS is the result of a U.S.-based joint-partnership established in 1991 between Merck & Co, Inc and Sanofi Pasteur, the vaccines unit of Sanofi, and draws upon both companies' experience in the development, manufacturing and marketing of individual and combination vaccines.


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Presentation

0.5 mL suspension for injection in pre-filled syringe.

Posology

Primary schedule: Two or three doses with at least one month between doses. Primary vaccination schedule should be given in accordance with the official recommendations.

Booster: After two-dose or three-dose primary series, a booster should be given at least six months after the last priming dose. Booster dose should be given in accordance with the official recommendations. As a minimum, a dose of Hib vaccine must be administered.

Age range

May be given from 6 weeks of age.

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Please note that the current UK routine childhood immunisation schedule does not include a booster dose after the initial 3 vaccinations at 8, 12 and 16 weeks old.

VAXELIS demonstrated high seroprotection rates, meeting primary endpoints for acceptability and non-inferiority to comparator vaccine*
for both 3+1 and 2+1 dosing patterns. 6-8

Following a 3+1 or 2+1 dosing schedule, long-term persistence of the immune response to hepatitis B and pertussis has been measured in children 4-5 years of age, and data suggests individuals are protected against hepatitis B for life.1

Please note that the current UK routine childhood immunisation schedule does not include a booster dose after the initial 3 vaccinations at 8, 12 and 16 weeks old.

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Seroprotection/Vaccine Response Rates One Month After Booster Vaccination.1
2+1 dosing: Booster at 11-12 months, after primary doses at 2, 4, months; N = 377-591.
3+1 dosing: Booster at 12 months after primary doses at 2, 3, 4 months; N = 439-551.

Please note that the current UK routine childhood immunisation schedule does not include a booster dose after the initial 3 vaccinations at 8, 12 and 16 weeks old.

a Vaccine response: If pre-dose 1 antibody concentration < LLOQ, then post-booster antibody concentration should be ≥ LLOQ; If pre-dose 1 antibody concentration ≥ LLOQ, then the post-booster antibody concentration should be ≥ pre-dose 1 levels. LLOQ=4 EU/mL are for anti-PT, anti-PRN and anti-FIM; and LLOQ=3 EU/mL for anti-FHA
b Did not receive hepatitis B vaccine at birth

Over 3,200 infants were involved in European studies with more than 1,900 infants receiving VAXELIS. The safety profile was generally similar to comparator vaccine for both 3+1 and 2+1 dosing patterns. 1,7-10

VAXELIS is fully liquid and comes ready-to-use in a pre-filled syringe, simplifying administration, reducing preparation time and
potentially errors. 1,2

Luer-lock syringe is designed to secure the connection to the needle and prevent leakage.

Shelf life of 4 years when stored at 2°C-8°C, the longest for a hexavalent vaccine.1,4 Stable at temperatures up to 25°C for 6.25 days (150 hours).1 This potentially leads to less wastage during shipment and storage due to temperature excursions.

*The comparator group received DTPa3-HBV-IPV/Hib

 

References:

  1. VAXELIS SmPC
  2. Lee AW, Jordanov E, Boisnard F, Marshall GS. DTaP5-IPV-Hib-HepB, a hexavalent vaccine for infants and toddlers. Expert Rev Vaccines. 2017 Feb;16(2):85-92. doi: 10.1080/14760584.2017.1268920. Epub 2016 Dec 20. PMID: 27996332.
  3. Greenberg DP, Doemland M, Bettinger JA, et al. Epidemiology of pertussis and haemophilus influenzae type b disease in Canada with exclusive use of diphtheria-tetanus-acellular pertussis inactivated poliovirus-haemophilus influenzae type b pediatric combination vaccine and an adolescent-adult tetanus-diphtheria-acellular pertussis vaccine: implications for disease prevention in the United States. Pediatr Infect Dis J. 2009;28(6):521-528
  4. Infanrix hexa SmPC
  5. 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
  6. European Medicines Agency: Assessment report Vaxelis. https://www.ema.europa.eu/en/medicines/ human/EPAR/vaxelis. Accessed July 2021.
  7. Vesikari T, Becker T, Vertruyen AF, et al. A phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at two, three, four and twelve months. Pediatr Infect Dis J. 2017;36(2):209-215. doi:10.1097/INF.0000000000001406
  8. Silfverdal S-A, Icardi G, Vesikari T, et al. A phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016;34(33):3810-3816.
  9. Oliver JL, Snape MD, Heath PT, et al. Investigational hexavalent vaccine administered concomitantly with meningococcal serogroup C conjugate vaccines during primary series. Poster 0936 presented at: 33rd meeting of the European Society for Paediatric Infectious Diseases (ESPID); 12-16 May 2015; Leipzig, Germany.
  10. Martinón-Torres F, et al. Immunogenicity and safety of a new hexavalent vaccine (DTaP5-IPV-HB-Hib) administered in a mixed primary series schedule with a pentavalent vaccine (DTaP5-IPV-Hib). Vaccine. 2017;35:3764-3772.

VAXELIS SmPC

Before you prescribe this vaccine, please refer to the Prescribing Information and Summary of Product Characteristics links below.

VAXELIS Prescribing information

View the Vaxelis SmPC

VAXELIS is suitable for use as part of the UK infant immunisation schedule at 8, 12 and 16 weeks old.

Primary vaccination:
The primary vaccination schedule consists of two or three doses, with an interval of at least 1 month between doses, and may be given from 6 weeks of age, in accordance with the official recommendations.

Booster vaccination:
After a 2-dose or a 3-dose primary series vaccination with Vaxelis, a booster dose should be given at least 6 months after the last priming dose. The booster dose should be given in accordance with official recommendations. As a minimum, a dose of Hib vaccine must be administered.1

VAXELIS can be given concomitantly with:1

  • Pneumococcal conjugate vaccines*
  • Rotavirus vaccines
  • Measles, mumps, rubella, and varicella-containing (MMRV) vaccines
  • Meningococcal C vaccines in infants

*Clinical data indicate that when VAXELIS is co-administered with pneumococcal conjugate vaccine (PCV13), the rate of fever is higher following the booster dose in the second year of life compared to the primary series; almost all fevers were mild or moderate and transient.1

Refer to the SmPC for more information.

Before you prescribe this vaccine, please refer to the Prescribing Information and Summary of Product Characteristics.

VAXELIS Prescribing information

View the Vaxelis SmPC


Useful Resources

NHS Vaccination Schedule

NHS Start4Life – Your baby’s vaccination schedule

UK Routine Immunisation Schedule

Immform

References:

  1. VAXELIS SmPC

 

Date of preparation: January 2022 | MAT-GB-2105621(v1.0)