Merck’s V114 Pneumococcal Vaccine Shows Promise in Pediatric Phase 3 Trials

Merck moved closer to offering its pneumococcal conjugate vaccine for use in pediatric populations with the recent announcement of positive topline results in 2 phase 3 pediatric clinical trials.

Merck’s investigational 15-valent pneumococcal conjugate vaccine, V114, showed promised in 2 Phase 3 pediatric clinical trials, the company recently announced.

The vaccine met the primary immunogenicity and safety endpoints in 2 trials—PNEU-DIRECTION (V114-027) and PNEU-PLAN (V114-024)—supporting its use in healthy infants and children.

“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, PhD, senior vice president and head of global clinical development, chief medical 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 so as to help sustain progress achieved to date.”

V114 includes 15 serotypes conjugated to a CRM197 carrier protein, including 2 serotypes commonly associated with invasive pneumococcal disease that aren’t contained in the currently licensed vaccines.

The PNEU-DIRECTION interchangeability study evaluated the vaccine in infants age 42 days to 90 days who may have previously started a 4-dose series of Pfizer’s 13-valent vaccine, PCV13. It included 900 participants randomized into 5 immunization groups. Immune responses were generally comparable for the 13 strains of the disease among infants who received all 4 doses of PCV13 and those who received a mixed-dose schedule of PCV13 and V114, Merck announced. Safety profiles were comparable across all groups.

The PNEU-PLAN catch-up study evaluated immune responses in children ages 7 months to 17 years who had either never received a pneumococcal vaccine or had received a partial or full regimen of the currently available vaccine. It included 606 participants and found that for the 2 serotypes not included in the PCV13 vaccine— 22F and 33F—immunogenicity was higher in the V114 group than in the PCV13 group. Immunogenicity was comparable for the other 13 serotypes. The study also showed the V114 was well tolerated with a comparable safety profile to PCV13.

“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.”

Merck said serotypes 22F and 33F represent 16% of all cases of invasive pneumococcal disease in children under the age of 5.

The company will present full results of the trials at a future scientific congress. The company’s Phase 3 program includes 16 studies involving more than 24,500 participants in 36 countries to evaluate the safety, tolerability and immunogenicity of the vaccine in various pediatric and adult populations.

Merck announced results of Phase 2 and 3 studies of the vaccine for use in adults in September, demonstrating safety, tolerability and immunogenicity.

In January, the company submitted a Biologics License Application for use of the vaccine in adults age 18 and older, and the US Food and Drug Administration is expected to reach a decision by July 18.