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The efficacy of live attenuated influenza vaccine against influenza-associated acute otitis media in children.
Pediatr Infect Dis J 2011; 30(3):203-7PI

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

Authors+Show Affiliations

Kentucky Pediatric and Adult Research, Bardstown, KY, USA. slblock@pol.netNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20935591

Citation

Block, Stan L., et al. "The Efficacy of Live Attenuated Influenza Vaccine Against Influenza-associated Acute Otitis Media in Children." The Pediatric Infectious Disease Journal, vol. 30, no. 3, 2011, pp. 203-7.
Block SL, Heikkinen T, Toback SL, et al. The efficacy of live attenuated influenza vaccine against influenza-associated acute otitis media in children. Pediatr Infect Dis J. 2011;30(3):203-7.
Block, S. L., Heikkinen, T., Toback, S. L., Zheng, W., & Ambrose, C. S. (2011). The efficacy of live attenuated influenza vaccine against influenza-associated acute otitis media in children. The Pediatric Infectious Disease Journal, 30(3), pp. 203-7. doi:10.1097/INF.0b013e3181faac7c.
Block SL, et al. The Efficacy of Live Attenuated Influenza Vaccine Against Influenza-associated Acute Otitis Media in Children. Pediatr Infect Dis J. 2011;30(3):203-7. PubMed PMID: 20935591.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The efficacy of live attenuated influenza vaccine against influenza-associated acute otitis media in children. AU - Block,Stan L, AU - Heikkinen,Terho, AU - Toback,Seth L, AU - Zheng,Wei, AU - Ambrose,Christopher S, PY - 2010/10/12/entrez PY - 2010/10/12/pubmed PY - 2011/5/25/medline SP - 203 EP - 7 JF - The Pediatric infectious disease journal JO - Pediatr. Infect. Dis. J. VL - 30 IS - 3 N2 - BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. SN - 1532-0987 UR - https://www.unboundmedicine.com/medline/citation/20935591/The_efficacy_of_live_attenuated_influenza_vaccine_against_influenza_associated_acute_otitis_media_in_children_ L2 - http://dx.doi.org/10.1097/INF.0b013e3181faac7c DB - PRIME DP - Unbound Medicine ER -