The U.S. FDA on Thursday approved an expanded indication for Merck & Co Inc.’s (NYSE:MRK) Capvaxive, extending its use to children and adolescents ages 2–17 with chronic conditions who have completed a primary pneumococcal vaccine series.

The decision makes Capvaxive the only pneumococcal conjugate vaccine specifically studied and indicated in the U.S. for this patient group.

Phase 3 STRIDE-13 data helped win approval. The data evaluated Capvaxive against PPSV23 in pediatric and adolescent patients at elevated risk of pneumococcal disease due to underlying medical conditions.

Merck said the trial formed the basis for the label expansion.

Capvaxive is already approved for adults 18 and older to help prevent invasive pneumococcal disease caused by multiple Streptococcus pneumoniae serotypes, as well as for at-risk patients aged 2–17.

The FDA had also previously granted accelerated approval ...