15-valent pneumococcal vaccine shows promise in children in phase 3 trials
Merck’s investigational V114 pneumococcal conjugate vaccine, which includes 15 serotypes, met its primary immunogenicity and safety endpoints in two phase 3 pediatric trials, the company announced.
Merck has already submitted the vaccine to the FDA for priority review for use in adults, with a decision expected by July 18. Pending that decision, Merck said it plans to submit a supplementary regulatory licensure application to the FDA for use in children by the end of the year.
“Pneumococcal disease continues to cause serious illness and death worldwide in children under the age of 5, despite the positive impact of pneumococcal conjugate vaccination on pediatric case numbers,” Roy Baynes, MD, PhD, head of global clinical development and chief medical officer for Merck, said in a new release. “Our goal is to expand coverage to new serotypes not targeted by currently available pediatric pneumococcal conjugate vaccines, while maintaining a strong immune response to current vaccine serotypes so as to help sustain progress achieved to date.”
According to the news release, data from the trials support the use of V114 in healthy infants who have already started a pneumococcal vaccination series with the currently available 13-valent pneumococcal conjugate vaccine (PCV13), or in a catch-up setting for healthy children who have not received a pneumococcal vaccine or who already received a full or partial regimen with lower valency pediatric pneumococcal conjugate vaccines.
In a study of infants aged 42 to 90 days, “immune responses in those who received a four-dose series of PCV13, and those who received a mixed dose schedule of PCV13 followed by V114, were generally comparable for the 13 serotypes, or strains of pneumococcal disease, targeted by both vaccines,” Merck said.
In a catch-up study, immune responses were comparable to PCV13 for the 13 shared serotypes when V114 was used as a catch-up regimen in healthy children aged 7 months to 17 years, who were either pneumococcal vaccine-naive or who previously received a partial or full regimen of a licensed pediatric PCV, according to the company.
In two serotypes included in the V114 vaccine but not the PCV13 — 22F and 33F — immunogenicity was higher in the V114 group than in the PCV13 group, the company reported.
Full results from both trials will be presented a future meeting, Merck said.