Merck (MSD) has reported that its 15-valent pneumococcal conjugate vaccine candidate, V114, met the primary immunogenicity and safety goals in two Phase III paediatric clinical trials, PNEU-DIRECTION and PNEU-PLAN.
The company’s V114 Phase III clinical development programme consists of 16 studies analysing the safety, tolerability and immunogenicity of the vaccine in people at high risk for pneumococcal disease, which is caused by Streptococcus pneumoniae bacteria.
In addition, the programme involves immunocompromised people or those with some chronic conditions.
The multi-centre, randomised, double-blind Phase III PNEU-DIRECTION trial assessed the safety, tolerability and immunogenicity of interchangeability of V114 and 13-valent pneumococcal conjugate vaccine, PCV13, in 900 healthy infants aged between 42 and 90 days.
Data from this trial showed that the immune responses were similar for the 13 serotypes in subjects receiving four-dose series of PCV13 and subjects receiving a mixed dosing schedule containing PCV13 followed by V114.
Meanwhile, the multi-centre, randomised, double-blind, active comparator-controlled, Phase III PNEU-PLAN trial analysed the safety, tolerability and immunogenicity of catch-up vaccination schedules of V114 in 606 healthy participants aged seven months to 17 years.
In these subjects who were either pneumococcal vaccine-naïve or who already received a partial or full paediatric pneumococcal conjugate vaccine, immune responses were similar to PCV13 for the 13 shared serotypes on administering V114 as a catch-up treatment.
Furthermore, immunogenicity for serotypes 22F and 33F in the PNEU-PLAN trial was found to be greater in the V114 arm versus the PCV13 arm.
Serotypes 22F and 33F, included in V114, are not present in the PCV presently licenced for use in children and adults.
V114 was observed to be well-tolerated with a safety profile similar to PCV13 in these trials.
Merck Research Laboratories chief medical officer and global clinical development senior vice-president and head Dr Roy Baynes said: “Results from these studies support the potential of V114 to confer immunogenicity for PCV13 serotypes in infants who have previously received one or multiple doses of PCV13, and for the 15 serotypes in V114 in children in a catch-up setting.”
In March this year, Merck and Eisai reported investigational data from the pivotal Phase III KEYNOTE-775/Study 309 trial of Keytruda plus Lenvima for treating endometrial cancer patients.