The Efficacy of Live Attenuated Influenza Vaccine Against Influenza-associated Acute Otitis Media in Children
ABSTRACT Acute otitis media (AOM) is a frequent complication of influenza in young children. Influenza vaccination is known to protect against AOM by preventing influenza illness. We sought to determine the efficacy of the live attenuated influenza vaccine (LAIV) against influenza-associated AOM compared with placebo and trivalent inactivated influenza vaccine (TIV). LAIV is approved for eligible children aged ≥ 2 years in the United States and in several other countries.
AOM incidence data from 6 randomized, double-blind, placebo-controlled trials and 2 randomized, double-blind, TIV-controlled trials in children 6 to 83 months of age were pooled and analyzed.
A total of 290 cases of AOM were identified in 24,046 study subjects. LAIV efficacy against influenza-associated AOM was 85.0% (95% confidence interval [CI], 78.3%-89.8%) compared with placebo and 54.0% (95% CI, 27.0%-71.7%) compared with TIV. Efficacy trended higher in those ≥ 24 months of age compared with those aged 6 to 23 months. In placebo-controlled trials, among children who acquired influenza despite vaccination, AOM was diagnosed in 10.3% of LAIV recipients and 16.8% of placebo recipients, representing a 38.2% (95% CI, 11.0%-58.2%) relative reduction in the development of AOM. In TIV-controlled studies, among subjects with breakthrough influenza illness, the proportions of LAIV and TIV recipients who developed AOM were similar.
Children receiving LAIV had a high level of protection against influenza-associated AOM when compared with placebo or TIV. This was most evident in children older than 2 years, for whom LAIV is indicated. LAIV recipients who contracted breakthrough influenza illness despite vaccination developed AOM at a significantly lower rate than did unvaccinated children who developed influenza.
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ABSTRACT: Accumulating evidence for the substantial burden of influenza in children has increased interest in the vaccination of young children against influenza. So far, however, few European countries have issued official recommendations to vaccinate healthy children, which is largely due to the popular belief that inactivated influenza vaccines are ineffective in young children. Virologically confirmed studies performed during different seasons have yielded widely varying estimates for vaccine effectiveness and suggested that the match between the vaccine and the circulating strains of influenza viruses is one of the key drivers of the effectiveness of the vaccine. In seasons with good antigenic match, inactivated influenza vaccines are clearly effective also in children younger than 2 years of age. The live attenuated influenza vaccine provides even greater effectiveness in children, but the overall potential of this vaccine is limited by its licensure for only children older than 2 years of age. The safety record of seasonal inactivated influenza vaccines is excellent even in the youngest children.Vaccine 08/2011; 29(43):7529-34. DOI:10.1016/j.vaccine.2011.08.011 · 3.49 Impact Factor
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ABSTRACT: During the past decade, accumulating data on the impact of influenza virus-related disease in children have become available. In this review, we summarize and discuss these data. We conclude that mortality due to influenza in children is relatively limited. But, in contrast, influenza-related hospitalizations occur frequently. The bulk of the influenza-related disease burden is experienced in the outpatient setting. This results in sometimes very high consultation rates, frequent complications, and substantial parental work absenteeism.Vaccine 08/2011; 29(43):7524-8. DOI:10.1016/j.vaccine.2011.08.010 · 3.49 Impact Factor
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ABSTRACT: Live attenuated influenza vaccine (LAIV) is an intranasally administered trivalent, seasonal influenza vaccine that contains three live influenza viruses (two type A [H1N1 and H3N2 subtypes] and one type B). LAIV was effective in protecting against culture-confirmed influenza caused by antigenically matched and/or distinct viral strains in children aged ≤71 months enrolled in three phase III trials. LAIV was superior to trivalent inactivated influenza vaccine (TIV) in protecting against influenza caused by antigenically-matching viral strains in a multinational phase III trial in children aged 6-59 months. LAIV was also significantly more effective than TIV in decreasing the incidence of culture-confirmed influenza illness in two open-label studies (in children with recurrent respiratory tract illnesses aged 6-71 months and in children and adolescents with asthma aged 6-17 years). LAIV did not differ significantly from placebo in preventing febrile illnesses in adults (primary endpoint) enrolled in a phase III trial. However, LAIV significantly reduced the incidence of febrile upper respiratory tract illnesses (URTI), severe febrile illnesses, febrile URTI-related work absenteeism and healthcare provider use. In another well designed trial in adults, LAIV significantly reduced the incidence of symptomatic, laboratory-confirmed influenza compared with placebo (but not intramuscular TIV). LAIV was generally well tolerated in most age groups, with the majority of adverse events being mild to moderate in severity, and runny nose/nasal congestion being the most common. In a large phase III trial, LAIV, compared with TIV, was associated with an increased incidence of medically significant wheezing in vaccine-naive children aged <24 months and an increased incidence of hospitalization in children aged 6-11 months; LAIV is not approved for use in children <24 months. LAIV was not always associated with high rates of seroconversion/seroresponse, particularly in older children and adults, or in subjects with detectable levels of haemagglutination-inhibiting antibodies at baseline. However, LAIV did elicit mucosal (nasal) IgA antibody responses and strong cell-mediated immunity responses. Only one confirmed case of LAIV virus transmission to a placebo recipient (who did not become ill) occurred in a transmission study conducted in young children. The immunogenic response to LAIV in young healthy children was not affected by concomitant administration with other commonly administered childhood vaccines. In conclusion, intranasal LAIV seasonal influenza vaccine is effective and well tolerated in children, adolescents and adults. LAIV was more effective than TIV in children, although this advantage was not seen in adults. In the US, LAIV is indicated for the active immunization of healthy subjects aged 2-49 years against influenza disease caused by virus subtypes A and type B contained in the vaccine.Drugs 08/2011; 71(12):1591-622. DOI:10.2165/11206860-000000000-00000 · 4.13 Impact Factor