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Flublok comparable to Flaurix in pediatric patients
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Flublok Quadrivalent provided comparable safety and immunogenicity compared with Fluarix Quadrivalent inactivated influenza vaccine in pediatric patients, particularly those aged 9 to 17 years, according to research published in Pediatrics.
“Seasonal influenza vaccines have transitioned recently to quadrivalent formulations containing antigens representing both influenza B lineages (Yamagata and Victoria) as well as conventional influenza A subtypes H1N1 and H3N2,” Lisa M. Dunkle, MD, of Protein Science Corp., and colleagues wrote. “The second influenza B lineage has been added to address the high frequency of circulation of both B lineages in a single season, and the common circulation of influenza B lineage mismatched with the vaccine strain.”
“Because children are especially susceptible to complications of influenza B, we therefore imitated the development of the quadrivalent, recombinant influenza vaccine (RIV4) in children aged 6 to 17 years,” the researchers wrote.
Dunkle and colleagues enrolled two age cohorts, including 159 patients aged 9 to 17 years and 60 children aged 6 to 8 years, who were reviewed for safety. The influenza season onset curtailed enrollment in the younger cohort. Flublock Quadrivalent, Lot 50-1302 (quadrivalent, recombinant influenza vaccine [RIV4], Protein Sciences Corp.) and Flaurix Quadrivalent, Lot 443Fz (inactivated influenza vaccine [IIV4], GlaxoSmithKline) were randomly assigned 1:1 to patients in both cohorts. Follow-up at 6 months was completed by 203 patients.
Before vaccination and 28 days after, the researchers obtained serum samples. Monitoring at 7 days after vaccination measured safety, and at 6 months after vaccination, measured tolerability.
“Both vaccines were well-tolerated in both age groups, and long-term follow-up revealed no vaccine-related adverse events,” the researchers wrote.
Patients in the older cohort had comparable antibody responses to most antigens when immunogenicity (geometric mean titers and seroconversion rate differences) was measured. Both vaccines produced low responses to the influenza B Victory lineage, which made it harder to interpret results.
The younger cohort showed similar immunogenicity for the two vaccines; however, researchers reported that the smaller sample size made it difficult to measure the results.
There were comparable safety profiles in terms of reactogenicity between the two vaccines in all patients.
“The safety, reactogenicity and immunogenicity of the RIV4 in pediatric subjects 6 to 17 years of age in this phase 2 exploratory trial are comparable to those in the profile of IIV4 in pediatric subjects at least 6 years of age,” the researchers concluded. – by Bruce Thiel
Disclosures: Dunkle reports serving as an employee and shareholder of Protein Sciences Corp., the manufacturer of Flublock Quadrivalent. Please see the full study for the other authors’ relevant financial disclosures.
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