Topline results for VAXNEUVANCE™ study in healthy infants announced

The topline results of the PNEU-PED (V114-029) study, which was evaluating the safety, tolerability, and immunogenicity of the 15-valent pneumococcal conjugate vaccine VAXNEUVANCE™ from Merck were announced today.¹

The trial had enrolled 1720 healthy infants aged between 42 and 90 days. The participants were given a 4-dose regiment of either the licensed 13-valent pneumococcal conjugate vaccine or VAXNEUVANCE™. Doses were received at 2, 4, 6, and 12-15 months of age. The study’s primary endpoints showed that the safety profile of VAXNEUVANCE™ was comparable to the 13-valent pneumococcal conjugate vaccine following the administration of any vaccine dose. Thirty days after the third dose, VAXNEUVANCE™ was found to be non-inferior to the 13-valent pneumococcal conjugate vaccine for all 13 of the shared serotypes. The same was true 30 days after the final, fourth dose. A secondary endpoint illustrated a statistically superior immune response from VAXNEUVANCE™ when compared to the 13-valent pneumococcal conjugate vaccine for shared serotype 3 and unique serotypes 22F and 33F. The full results of the trial will be released at an upcoming conference.

VAXNEUVANCE™ was approved by the US Food and Drug Administration for use in patients aged 18 years and older for active immunization. Merck indicated that the vaccine is on track for the submission of a supplemental regulatory licensure application to allow use in children by the end of 2021.

Reference

1. Merck. Merck announces VAXNEUVANCE™ (pneumococcal 15-valent conjugate vaccine) met key immunogenicity and safety endpoints in phase 3 pivotal trial evaluating use in infants, PNEU-PED (V114-029).Published August 25, 2021. Accessed August 25, 2021. https://www.merck.com/news/merck-announces-vaxneuvance-pneumococcal-15-valent-conjugate-vaccine-met-key-immunogenicity-and-safety-endpoints-in-phase-3-pivotal-trial-evaluating-use-in-infants-pneu-ped-v114-029/