dm+d

34771611000001101

Refrigerated Storage

Infanrix hexaGSK

GSK
Infanrix hexa
Powder and suspension for injection

In the event of an inadvertent temperature excursion the following data may be used:
Stability data indicate that the vaccine components are stable at temperatures up to 25°C for a cumulative time of 72 hours.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact GSK in cases where the product has been exposed to temperature deviation other than described above. Refer to the current BNF for company contact details.

No - if exposed to the temperature conditions above
Yes - if exposed to the temperature conditions above

Do not Freeze

25 November 2020
London Medicines Information Service

New Medicines

VaxelisVaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and haemophilus

Information

Vaxelis
Vaccine
Sanofi Pasteur
Merck & Co (name used in US for MSD)

Development and Regulatory status

Licensed but not launched
Licensed but not launched
Launched
Sep 21Sanofi has no current plans to launch this in the UK [6].
Jun 21Vaxelis launched in the US. It is the first and only hexavalent (six-in-one) combination vaccine available in the US. indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. In Feb 21, the US Centers for Disease Control and Prevention ’s Advisory Committee included Vaxelis as a combination vaccine option in the CDC Recommended Child and Adolescent Immunization Schedule. Vaxelis will be widely available in the US through traditional public and private channels, including directly from Sanofi Pasteur via vaccineshoppe.com [7].
Dec 19Not listed in company pipeline, plans for UK availability uncertain at this point [5].
Feb 19Merck intends to launch Hib-DTaP-Hepatitis-B-Poliovirus-vaccine in 2020 [4].
Dec 18US FDA approves hexa-valent DTaP-HepB-Polio-Hib vaccine (VaxelisTM) indicated for active immunization to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases Haemophilus influenzae type b. The vaccine is approved for use as a 3-dose series in infants and children aged 6 weeks to 4 years [4].
Feb 16EC grants marketing authorisation for hexa-valent DTaP-HepB-Polio-Hib vaccine (Vaxelis®), indicated for primary and booster vaccination of infants and toddlers from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b [4].
Dec 15EU CHMP issues a positive opinion on approval [4].
Nov 15Merck and Sanofi Pasteur receive a complete response letter (CRL) from the US FDA with respect to the BLA for hexa-valent DTaP-HepB-Polio-Hib vaccine. The CRL is under review by both companies and further communication with the FDA is planned [4].
Jan 15The EMA accepted the marketing authorisation application for the paediatric hexavalent vaccine [3].
Oct 14Merck & Co. and sanofi pasteur submitted a BLA for approval of the vaccine to the US FDA in the second half of 2014. The agency accepted the BLA in October 2014. Data from a phase III clinical trial in more than 1400 infants in the US were included in the submission [3].

Category

Vaccine
Not applicable. This product is preventative for a number of diseases
Vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and haemophilus
Intramuscular

Trial or other data

Oct 14Sanofi pasteur MSD completed a phase III trial designed to assess the safety and immunogenicity of the hexavalent (DTaP-HepB-Polio-Hib) vaccine and Hib-DTaP-poliovirus vaccine, as a primary schedule, in healthy infants (NCT01839188). The open-label trial, which initiated in May 2013, enrolled 385 volunteers, aged 46 to 76 days in Spain [3].
Mar 14Another phase III trial investigated the safety, tolerability and immunogenicity of the vaccine compared with Infanrix® hexa, after each was given concomitantly with Prevnar 13® and RIX 4414 (Rotarix®), in 1315 healthy infants (NCT01480258)[3].
Oct 13Merck & Co. and sanofi pasteur are collaborating in the development of a paediatric hexavalent vaccine (DTaP-HepB-Polio-Hib), to prevent Haemophilus influenza type B, diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis infections. [2]
Mar 13A phase III trial was completed in Belgium, Finland and Germany; enrolling 1250 infants by February 2012 (NCT01341639). This study investigated the safety, tolerability and immunogenicity of the vaccine in patients vaccinated at 2, 3, 4, and 12 months of age. The study aimed to determine whether the immune response to the hexavalent vaccine is equivalent to that of patients receiving a licensed Hib-DTaP-hepatitis B-poliovirus vaccine control (Infanrix® hexa)[3].
May 12Randomised, double-blind study (NCT01340937) completed recruitment of approximately 2800 infants, aged between 46 and 89 days. The trials are sponsored by Merck, and conducted in collaboration with sanofi pasteur[3].
Mar 12Sanofi Pasteur initiated a phase III trial that investigated the immunogenicity and reactogenicity of the vaccine administered concomitantly with two types of meningococcal serogroup C conjugate vaccines (NCT01553279). This study enrolled 284 healthy infants aged between 46 and 74 days in the UK [3].
May 11The phase III US-based programme for the vaccine was initiated in April 2011. The programme includes a randomised, open-label, active-comparator controlled trial, which enrolled 1473 infants, and was completed in May 2013 (NCT01337167). The vaccine was administered at 2, 4, and 6 months of age concomitantly with Prevnar 13® and RotaTeq®. A second phase III trial was initiated to evaluate the immunogenicity of the vaccine also administered in combination with Prevnar 13® and RotaTeq® (NCT01340937)[3].