Merck’s 15-valent pneumococcal conjugate vaccine, V114, was promised in 2 Phase 3 pediatric clinical trials, the company recently announced.
The vaccine met primary immunogenicity and safety endpoints in 2 studies – PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024) – supporting use in healthy infants and children.
“Pneumococcal disease continues to cause serious morbidity and death in children under 5 years of age worldwide, despite the positive impact of pneumococcal conjugate vaccination on pediatric cases,” Roy Baynes, PhD, senior vice president and head of global clinical development, chief medical officer officer, Merck Research Laboratories, said. “At Merck, 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 to support the progress made to date.”
V114 comprises 15 serotypes conjugated to a CRM197 carrier protein, including 2 serotypes commonly associated with invasive pneumococcal disease that are not present in currently approved vaccines.
The PNEU-DIRECTION interchangeability study evaluated the vaccine in infants aged 42 to 90 days who may have started earlier with a 4-dose series of Pfizer’s 13-valent vaccine, PCV13. It included 900 participants randomized into 5 immunization groups. Immune responses were generally similar for the 13 strains of the disease in infants who received all 4 doses of PCV13 and those who received a mixed dosing schedule of PCV13 and V114, Merck announced. Safety profiles were similar in all groups.
The PNEU-PLAN catch-up study evaluated immune response in children aged 7 months to 17 years who had either never received a pneumococcal vaccine or received partial or full treatment with the currently available vaccine. It included 606 participants and found that for the 2 serotypes not included in the PCV13 vaccine – 22F and 33F – the immunogenicity was higher in the V114 group than in the PCV13 group. Immunogenicity was similar for the other 13 serotypes. The study also showed that the V114 was well tolerated with a safety profile comparable to PCV13.
“The results of these studies support the potential of V114 to confer immunogenicity for PCV13 serotypes in infants previously given single or multiple doses of PCV13, and for the 15 serotypes in V114 in catch-up children.”
Merck said serotypes 22F and 33F account for 16% of all cases of invasive pneumococcal disease in children under 5 years of age.
The company will present the full results of the trials at a future scientific conference. The company’s Phase 3 program includes 16 studies with more than 24,500 participants in 36 countries to evaluate the vaccine’s safety, tolerability and immunogenicity in various pediatric and adult populations.
Merck announced the results of Phase 2 and 3 trials of the vaccine for use in adults in September, demonstrating its safety, tolerability and immunogenicity.
In January, the company filed a Biologics License Application for use of the vaccine in adults ages 18 and older, and the U.S. Food and Drug Administration is expected to make a decision on July 18.