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QIV safe, immunogenic in children aged 6 months to younger than 9 years
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Children aged 6 months to younger than 9 years can be effectively vaccinated against influenza with a quadrivalent influenza vaccine, according to recent study findings published in The Pediatrics Infectious Disease Journal.
David P. Greenberg, MD, vice president, US scientific and medical affairs, Sanofi Pasteur, and colleagues evaluated 4,328 children aged 6 months to younger than 9 years to determine the safety and immunogenicity of inactivated quadrivalent influenza vaccine (QIV; Fluzone Quadrivalent, Sanofi Pasteur) compared with inactivated trivalent influenza vaccines (TIVs) containing opposite B-lineage strains. QIV was administered to 2,893 patients, 734 received the licensed TIV and 721 received the investigational TIV.
Across all groups, geometric mean titers were similar. TIV and QIV yielded similar geometric mean titers and seroconversion rates for influenza A/H1N1 and influenza A/H3N2. QIV and TIV yielded similar geometric mean titers and seroconversion rates for the B strains included in each, but QIV was superior to TIV when the B strain was not included. All three groups had similar post-vaccination seroconversion rates.
Irritability and injection-site tenderness were the most common reactions among children aged 6 months to younger than 24 months and myalgia, malaise and injection-site pain were for the most common reactions among children aged 2 years to younger than 9 years. Unsolicited immediate adverse events were reported in less than 1% of patients among all through three vaccine groups. The most commonly reported were cough, upper respiratory tract infection, fever, and vomiting.
Five patients discontinued QIV administration because of adverse events possibly related to vaccination. No patients receiving TIV discontinued administration due to adverse events.
“In conclusion, the safety and immunogenicity of QIV was comparable to licensed TIV in a healthy pediatric population,” the researchers wrote. “By inducing antibody responses to both B lineages simultaneously, QIV should help overcome the limitations of TIV, namely, its inability to protect against both co-circulating B lineages simultaneously and that it often does not contain the B-lineage strain predominating in a given influenza season.”
Disclosure: The study was funded in part by Sanofi Pasteur. All researchers report financial ties with Sanofi Pasteur.
Perspective
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Pedro A. Piedra, MD
This article reported on the safety and immunogenicity of a quadrivalent inactivated influenza vaccine (QIV; Fluzone Quadrivalent, Sanofi Pasteur). The study was a phase 3, randomized, multicenter trial conducted in children 6 months to less than 9 years of age. Greenberg and colleagues demonstrated the QIV was well tolerated, immunogenic and induced levels of antibodies associated with protection against all four influenza viruses. Annual influenza vaccination in the United States is the cornerstone of the recommendations made by the Advisory Committee on Immunization Practices (ACIP) for the prevention of influenza-related morbidity and mortality. Each year influenza outbreaks of varying intensity impact the pediatric population. In any given year, one to four different influenza viruses are circulating and causing disease. Since 2001 two influenza B lineages (B/Yamagata and B/Victoria) have been circulating in the United States, and in some years viruses of both lineages co-circulate. Until this past year (2013 to 2014), the influenza vaccines were trivalent, providing protection against influenza A/H1N1, influenza A/H3N2 and one of two influenza B lineages. It was hit or miss in choosing the correct influenza B lineage. To improve the breath of coverage provided by the influenza vaccines, many of the vaccine manufactures have developed quadrivalent formulations. The currently approved quadrivalent vaccines in the United States are Fluarix Quadrivalent (GlaxoSmithKline), Flulaval Quadrivalent (ID Biomedical), Fluzone Quadrivalent and FluMist Quadrivalent (MedImmune). The quadrivalent influenza vaccines are safe, well tolerated and expected to provide better coverage against the influenza viruses.
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