STN: 125682
Proper Name: Dengue Tetravalent Vaccine, Live
Tradename: DENGVAXIA
Manufacturer: Sanofi Pasteur Inc.
Indication:

• Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4. DENGVAXIA is approved for use in individuals 9 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

Product Information

• Package Insert - DENGVAXIA
• Demographic Subgroup Information – DENGVAXIA (Dengue Tetravalent Vaccine, Live)
  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

• January 22, 2020 Approval Letter - DENGVAXIA
• May 1, 2019 Approval Letter - DENGVAXIA
• May 1, 2019 Summary Basis for Regulatory Action - DENGVAXIA
• April 30, 2019 Statistical Review - DENGVAXIA
• Approval History, Letters, Reviews, and Related Documents - DENGVAXIA