Fluarix Quadrivalent Labeling Updated With Data Related to Concomitant Shingrix Administration

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 (≥37.5^o 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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