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Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial.

Abstract

CONTEXT

Acute otitis media (AOM) frequently complicates influenza infection. Previous studies have found influenza vaccine effective in reducing the occurrence of AOM in children mainly older than 2 years.

OBJECTIVE

To evaluate the effectiveness of inactivated influenza vaccine in preventing AOM in children aged 6 to 24 months.

DESIGN, SETTING, AND PATIENTS

Randomized, double-blind, placebo-controlled trial of 786 children aged 6 to 24 months enrolled at Children's Hospital of Pittsburgh before the 1999-2000 (411 children) and 2000-2001 (375 children) respiratory seasons (defined as December 1 through March 31 of the respective following year). Children received influenza vaccine or placebo in a 2:1 ratio. The first cohort was observed for 1 year and the second cohort until the end of the ensuing respiratory season.

INTERVENTION

Two doses (0.25 mL each) of inactivated trivalent subvirion influenza vaccine or placebo were administered intramuscularly approximately 4 weeks apart.

MAIN OUTCOME MEASURES

Proportion of children who developed AOM, monthly occurrence rate of AOM, estimated proportion of time with middle ear effusion, and utilization of selected health care and related resources.

RESULTS

Of the 66 children in the vaccine group from whom serum samples were collected, seroconversion against strains in the vaccine formulations developed in 88.6% to 96.8%, depending on the specific strain. The efficacy of the vaccine against culture-confirmed influenza was 66% (95% confidence interval [CI], 34%-82%) in 1999-2000 and -7% (95% CI, -247% to 67%) in 2000-2001; however, influenza attack rates differed between these 2 periods (in the placebo group, 15.9% and 3.3%, respectively). Compared with placebo, influenza vaccine did not reduce the proportion of children who had at least 1 episode of AOM during the respiratory season (in the first cohort: vaccine, 49.2% vs placebo, 52.2%; P =.56 ]; in the second cohort: vaccine, 55.8% vs placebo, 48.3%; P =.17). The vaccine also did not reduce the monthly rate of AOM; the estimated proportion of time with middle ear effusion; or the utilization of selected health care and related resources. There were also no differences between the vaccine and placebo groups regarding any of these outcomes during peak influenza periods. The vaccines administered to both cohorts of children were well tolerated.

CONCLUSION

Administration of inactivated trivalent influenza vaccine to children aged 6 to 24 months did not reduce their burden of AOM or their utilization of selected health care and related resources.

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  • Authors+Show Affiliations

    ,

    Department of Pediatrics, School of Medicine, University of Pittsburgh, Pittsburgh, Pa, USA. hoberman@chp.edu

    , , , , , , , , , , , ,

    Source

    JAMA 290:12 2003 Sep 24 pg 1608-16

    MeSH

    Acute Disease
    Antibodies, Viral
    Double-Blind Method
    Health Services
    Humans
    Infant
    Influenza Vaccines
    Influenza, Human
    Orthomyxoviridae
    Otitis Media

    Pub Type(s)

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

    Language

    eng

    PubMed ID

    14506120

    Citation

    Hoberman, Alejandro, et al. "Effectiveness of Inactivated Influenza Vaccine in Preventing Acute Otitis Media in Young Children: a Randomized Controlled Trial." JAMA, vol. 290, no. 12, 2003, pp. 1608-16.
    Hoberman A, Greenberg DP, Paradise JL, et al. Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial. JAMA. 2003;290(12):1608-16.
    Hoberman, A., Greenberg, D. P., Paradise, J. L., Rockette, H. E., Lave, J. R., Kearney, D. H., ... Kerr, J. D. (2003). Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial. JAMA, 290(12), pp. 1608-16.
    Hoberman A, et al. Effectiveness of Inactivated Influenza Vaccine in Preventing Acute Otitis Media in Young Children: a Randomized Controlled Trial. JAMA. 2003 Sep 24;290(12):1608-16. PubMed PMID: 14506120.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effectiveness of inactivated influenza vaccine in preventing acute otitis media in young children: a randomized controlled trial. AU - Hoberman,Alejandro, AU - Greenberg,David P, AU - Paradise,Jack L, AU - Rockette,Howard E, AU - Lave,Judith R, AU - Kearney,Diana H, AU - Colborn,D Kathleen, AU - Kurs-Lasky,Marcia, AU - Haralam,Mary Ann, AU - Byers,Carol J, AU - Zoffel,Lisa M, AU - Fabian,Irene A, AU - Bernard,Beverly S, AU - Kerr,Jill D, PY - 2003/9/25/pubmed PY - 2003/9/30/medline PY - 2003/9/25/entrez SP - 1608 EP - 16 JF - JAMA JO - JAMA VL - 290 IS - 12 N2 - CONTEXT: Acute otitis media (AOM) frequently complicates influenza infection. Previous studies have found influenza vaccine effective in reducing the occurrence of AOM in children mainly older than 2 years. OBJECTIVE: To evaluate the effectiveness of inactivated influenza vaccine in preventing AOM in children aged 6 to 24 months. DESIGN, SETTING, AND PATIENTS: Randomized, double-blind, placebo-controlled trial of 786 children aged 6 to 24 months enrolled at Children's Hospital of Pittsburgh before the 1999-2000 (411 children) and 2000-2001 (375 children) respiratory seasons (defined as December 1 through March 31 of the respective following year). Children received influenza vaccine or placebo in a 2:1 ratio. The first cohort was observed for 1 year and the second cohort until the end of the ensuing respiratory season. INTERVENTION: Two doses (0.25 mL each) of inactivated trivalent subvirion influenza vaccine or placebo were administered intramuscularly approximately 4 weeks apart. MAIN OUTCOME MEASURES: Proportion of children who developed AOM, monthly occurrence rate of AOM, estimated proportion of time with middle ear effusion, and utilization of selected health care and related resources. RESULTS: Of the 66 children in the vaccine group from whom serum samples were collected, seroconversion against strains in the vaccine formulations developed in 88.6% to 96.8%, depending on the specific strain. The efficacy of the vaccine against culture-confirmed influenza was 66% (95% confidence interval [CI], 34%-82%) in 1999-2000 and -7% (95% CI, -247% to 67%) in 2000-2001; however, influenza attack rates differed between these 2 periods (in the placebo group, 15.9% and 3.3%, respectively). Compared with placebo, influenza vaccine did not reduce the proportion of children who had at least 1 episode of AOM during the respiratory season (in the first cohort: vaccine, 49.2% vs placebo, 52.2%; P =.56 ]; in the second cohort: vaccine, 55.8% vs placebo, 48.3%; P =.17). The vaccine also did not reduce the monthly rate of AOM; the estimated proportion of time with middle ear effusion; or the utilization of selected health care and related resources. There were also no differences between the vaccine and placebo groups regarding any of these outcomes during peak influenza periods. The vaccines administered to both cohorts of children were well tolerated. CONCLUSION: Administration of inactivated trivalent influenza vaccine to children aged 6 to 24 months did not reduce their burden of AOM or their utilization of selected health care and related resources. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/14506120/Effectiveness_of_inactivated_influenza_vaccine_in_preventing_acute_otitis_media_in_young_children:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.290.12.1608 DB - PRIME DP - Unbound Medicine ER -