The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Fluarix Quadrivalent (quadrivalent inactivated “split virus” influenza vaccine; GlaxoSmithKline) to include updated data related to concomitant administration with Zoster Vaccine Recombinant, Adjuvanted (Shingrix) vaccine.
Fluarix Quadrivalent is indicated for the active immunization for the prevention of disease caused by influenza A subtype viruses and type B viruses in patients aged ≥6 months. Shingrix is indicated for the prevention of herpes zoster in patients aged ≥50 years.
The updated labeling includes the immunogenicity and safety data from an open-label, multicenter phase 3 trial (NCT01954251) of 828 adults aged ≥50 years who received either Fluarix Quadrivalent and Shingrix at month 0 and Shingrix at month 2 (n=413), or Fluarix Quadrivalent at month 0 and Shingrix at month 2 and 4 (n=415). Results showed that there was no evidence of interference in antibody responses (haemagglutination inhibition [HI] antibodies and anti-gE antibodies) to Fluarix Quadrivalent or Shingrix.
With regard to safety, the rates of solicited, systemic adverse reactions of fatigue, headache, myalgia, shivering, and fever (≥37.5o C) reported in patients receiving Fluarix Quadrivalent and Shingrix concomitantly were similar to those observed with Shingrix alone, and higher than when Fluarix Quadrivalent was given alone.
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