A PIV, single-blind, randomised, multi-country trial to evaluate the immunogenicity and safety of GSK´s Infanrix Hexa (DTPa-HBV-IPV/Hib) vs Vaxelis (DTaP5-HBV-IPV Hib) when administered intramuscularly according to a 2-, 4- and 12-month schedule in healthy infants and toddlers is recruiting (NCT04535037, n=500). Estimated primary completion date Oct 2022. Primary outcome measures include antibody concentrations one months post vaccination 
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 .
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).
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. 
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).
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.
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 .
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).