Merck: VAXNEUVANCE Meets Endpoints In Phase 3 Trial Evaluating Use In Infants

(RTTNews) - Merck (MRK) said VAXNEUVANCE met key immunogenicity and safety endpoints in the PNEU-PED study in healthy infants. The Pneumococcal 15-valent Conjugate Vaccine showed a safety profile generally comparable to the licensed 13-valent pneumococcal conjugate vaccine (PCV13). At 30 days following the third dose, VAXNEUVANCE was non-inferior to PCV13 for all 13 shared serotypes.

Merck said VAXNEUVANCE also achieved key safety objectives in the phase 3 PNEU-LINK (V114-031) study in infants.

On July 16, 2021, the FDA approved VAXNEUVANCE for adults 18 years of age. The company said its plans are on track for submission of a supplemental regulatory licensure application to the FDA for use in children before the end of the year.