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
VAXELIS Prescribing information
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. |
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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. |
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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.
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:
Before you prescribe this vaccine, please refer to the Prescribing Information and Summary of Product Characteristics links below.
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
*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.
VAXELIS Prescribing information
NHS Start4Life – Your baby’s vaccination schedule
UK Routine Immunisation Schedule
References:
Date of preparation: January 2022 | MAT-GB-2105621(v1.0)
