GSK vaccine meets phase II endpoints

GlaxoSmithKline (GSK) has announced the results of a phase II clinical trial of its combination vaccine candidate Hib-MenCY-TT, with the drug meeting its endpoints of safety and immunogenicity in infants when compared to existing vaccines.

The trial results suggested that Hib-MenCY-TT could potentially prevent the contraction of invasive meningococcal disease caused by three bacteria; Haemophilus influenzae type b (Hib) and Neisseria meningitidis serogroups C and Y.

In the study, the safety and immune response of the vaccine was compared to that of ActHib – a Hib conjugate vaccine tetanus toxoid conjugate – and Menomune – a meningococcal polysaccharide vaccine against serogroups A, C, Y and W-135 combined.

Jacqueline M Miller, director of clinical research and development and medical affairs, said: “Infants 12 months of age and younger are at the greatest risk of having meningococcal infections.”

She added that Hib-MenCY-TT had been designed for use in well child visits at two, four, six, 12 and 15 months old, noting that – if approved at the suggested dose – the vaccination would not result in a rise in the number of injections recommended for paediatric immunisation.

Last week, GSK announced the results of a clinical study of Cervarix in women aged 15 to 55, with use of the compound resulting in an immune response in patients to human papillomavirus types 16 and 18.