DTAP5-HepB-Polio-Hib

Unassigned

New Medicines

Vaccination diphtheria, tetanus, pertussis, haemophilus, hep B, polio

Information

New formulation
Sanofi Pasteur
Merck & Co (name used in US for MSD)

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
01. Jan 15: The EMA accepted the marketing authorisation application for the paediatric hexavalent vaccine [3].
02. Oct 14: Merck & 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 diphtheria, tetanus, pertussis, haemophilus, hep B, polio
Intramuscular

Trial or other data

01. May 11: The 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].
02. Mar 12: Sanofi 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].
03. May 12: Randomised, 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].
04. Mar 13: A 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].
05. Oct 13: Merck & 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]
06. Mar 14: Another 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].
07. Oct 14: Sanofi 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].