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# FDA OKs Sanofi’s Fluzone Quadrivalent for Infants
- URL: https://www.fdaweb.com/fda-oks-sanofis-fluzone-quadrivalent-for-infants/
- Published: 2019-01-24T12:00:00.000Z
- Updated: 2026-09-15T00:56:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143219

FDA has approved Sanofi Pasteur’s 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Approval is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children, which demonstrated that one or two doses of 0.5 mL of vaccine in children 6 through 35 months of age had a safety profile that was comparable to one or two doses of 0.25 mL of the vaccine with no new safety concerns observed, and induced a robust immune response, Sanofi says. During trials, common reported adverse events included pain at the injection site, headache and myalgia.