STN: 125741
Proper Name:  Pneumococcal 15-valent Conjugate Vaccine
Tradename: VAXNEUVANCE
Manufacturer:  Merck Sharp & Dohme LLC
Indication: Active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in individuals 6 weeks of age and older.

Product Information

• Package Insert - VAXNEUVANCE
• Patient Information - VAXNEUVANCE
• Demographic Subgroup Information – Pneumococcal 15-valent Conjugate Vaccine (VAXNEUVANCE)
  Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Supporting Documents

• May 25, 2023 Approval Letter - VAXNEUVANCE
• Statistical Review (STN 125741/6) - VAXNEUVANCE
• June 17, 2022 Clinical Review (STN 125741/6) - VAXNEUVANCE
• June 17, 2022 Approval Letter - VAXNEUVANCE
• July 16, 2021 Approval Letter - VAXNEUVANCE
• July 16, 2021 Summary Basis for Regulatory Action - VAXNEUVANCE
• Approval History, Letters, Reviews, and Related Documents - VAXNEUVANCE