Tweet
Pediatr Infect Dis J. 2018 Feb 19. doi: 10.1097/INF.0000000000001949. [Epub ahead of print]
Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children.
Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R.
Abstract
BACKGROUND:
Comparing post-vaccination fever rates in pediatric influenza vaccine clinical trials is difficult due to variability in how fever is reported. The impact of vaccine-related fever and antipyretic use on trivalent influenza vaccine (TIV) immunogenicity in children is also unclear.
METHODS:
In this pilot study, we obtained individual-level data provided by GlaxoSmithKline (GSK) from three pediatric clinical trials of GSK versus comparator TIV. We explored a primary study (NCT00764790), the largest trial involving young children (6-35 months, n=3317), and further explored key findings in the two other trials (3-17 years, NCT00980005; 6m-17y NCT00383123). We analyzed post-vaccination fever and antipyretic use, and their association with immunogenicity through use of multivariable regression.
RESULTS:
Post-vaccination fever data were re-analyzed from the primary study using the Brighton Collaboration standardized definition (vaccine-related fever ≥38?C, measured by any route, reported after each dose). Rates were substantially lower after first (2.7-3.4%) and second doses (3.3-4.1%), than those published (6.2-6.6%; combined dose data, any causality). A pooled immunogenicity analysis combining the 3 studies (n=5902) revealed children with post-vaccination fever had significantly higher adjusted Geometric Mean Titers (GMT) than those without fever (ratio 1.21-1.39; p≤0.01). Conversely those with antipyretic use had significantly lower adjusted GMTs (ratio 0.80-0.87; p<0.0006), dependent on virus strain.
CONCLUSIONS:
Varying analyses and reporting methods can result in substantially different reported fever rates in studies. Standardized reporting of fever is needed to facilitate comparison between studies. Fever and antipyretic use may have important associations with influenza vaccine immunogenicity in children and need further prospective investigation.
PMID: 29465480 DOI: 10.1097/INF.0000000000001949
Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children.
Li-Kim-Moy J, Wood N, Jones C, Macartney K, Booy R.
Abstract
BACKGROUND:
Comparing post-vaccination fever rates in pediatric influenza vaccine clinical trials is difficult due to variability in how fever is reported. The impact of vaccine-related fever and antipyretic use on trivalent influenza vaccine (TIV) immunogenicity in children is also unclear.
METHODS:
In this pilot study, we obtained individual-level data provided by GlaxoSmithKline (GSK) from three pediatric clinical trials of GSK versus comparator TIV. We explored a primary study (NCT00764790), the largest trial involving young children (6-35 months, n=3317), and further explored key findings in the two other trials (3-17 years, NCT00980005; 6m-17y NCT00383123). We analyzed post-vaccination fever and antipyretic use, and their association with immunogenicity through use of multivariable regression.
RESULTS:
Post-vaccination fever data were re-analyzed from the primary study using the Brighton Collaboration standardized definition (vaccine-related fever ≥38?C, measured by any route, reported after each dose). Rates were substantially lower after first (2.7-3.4%) and second doses (3.3-4.1%), than those published (6.2-6.6%; combined dose data, any causality). A pooled immunogenicity analysis combining the 3 studies (n=5902) revealed children with post-vaccination fever had significantly higher adjusted Geometric Mean Titers (GMT) than those without fever (ratio 1.21-1.39; p≤0.01). Conversely those with antipyretic use had significantly lower adjusted GMTs (ratio 0.80-0.87; p<0.0006), dependent on virus strain.
CONCLUSIONS:
Varying analyses and reporting methods can result in substantially different reported fever rates in studies. Standardized reporting of fever is needed to facilitate comparison between studies. Fever and antipyretic use may have important associations with influenza vaccine immunogenicity in children and need further prospective investigation.
PMID: 29465480 DOI: 10.1097/INF.0000000000001949