This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Citation map  • Citing articles on HighWire  • Citing articles on Web of Science (90)  • Contact me when this article is cited  Related Content  • Related letters  • Related articles  • Similar articles in JAMA  Topic Collections  • Otolaryngology/ Head & Neck Surgery  • Middle/ External Ear Disorders  • Pediatrics  • Pediatrics, Other  • Randomized Controlled Trial  • Alert me on articles by topic  Social Bookmarking   What's this?

A Randomized Controlled Trial

Alejandro Hoberman, MD; David P. Greenberg, MD; Jack L. Paradise, MD; Howard E. Rockette, PhD; Judith R. Lave, PhD; Diana H. Kearney, RN; D. Kathleen Colborn, BS; Marcia Kurs-Lasky, MS; Mary Ann Haralam, CRNP; Carol J. Byers, CRNP; Lisa M. Zoffel, CRNP; Irene A. Fabian, CRNP; Beverly S. Bernard, CRNP; Jill D. Kerr, RN

JAMA. 2003;290:1608-1616.

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.

Author Affiliations: Department of Pediatrics (Drs Hoberman, Greenberg, and Paradise), School of Medicine, and Departments of Biostatistics (Dr Rockette and Ms Kurs-Lasky) and Health Services Administration (Dr Lave), Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pa; and Children's Hospital of Pittsburgh (Mss Kearney, Colborn, Haralam, Byers, Zoffel, Fabian, Bernard, and Kerr).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?

RELATED LETTERS

Effectiveness of Influenza Vaccine to Prevent Acute Otitis Media
Terho Heikkinen and Olli Ruuskanen
JAMA. 2004;291(6):692-693.
EXTRACT | FULL TEXT  

Effectiveness of Influenza Vaccine to Prevent Acute Otitis Media
Tasnee Chonmaitree and James Grady
JAMA. 2004;291(6):693.
EXTRACT | FULL TEXT  

Effectiveness of Influenza Vaccine to Prevent Acute Otitis Media—Reply
Alejandro Hoberman, David P. Greenberg, and Jack L. Paradise
JAMA. 2004;291(6):693-694.
EXTRACT | FULL TEXT  

Influenza Vaccination Effectiveness Is Not Proven in Younger Individuals at Risk
Roger Damoiseaux, Johannes C. van der Wouden, and Herman Bueving
Arch Intern Med. 2005;165(16):1921-1922.
EXTRACT | FULL TEXT  

Influenza Vaccination Effectiveness Is Not Proven in Younger Individuals at Risk—Reply
Eelko Hak, Erik Buskens, and Theo J. M. Verheij
Arch Intern Med. 2005;165(16):1922.
EXTRACT | FULL TEXT  

RELATED ARTICLES

Does This Child Have Acute Otitis Media?
Russell Rothman, Thomas Owens, and David L. Simel
JAMA. 2003;290(12):1633-1640.
ABSTRACT | FULL TEXT  

Acute Otitis Media
Sharon Parmet, Cassio Lynm, and Richard M. Glass
JAMA. 2003;290(12):1666.
EXTRACT | FULL TEXT  

THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES

Vaccine Effectiveness Against Laboratory-Confirmed Influenza in Children 6 to 59 Months of Age During the 2003-2004 and 2004-2005 Influenza Seasons
Eisenberg et al.
Pediatrics 2008;122:911-919.
ABSTRACT | FULL TEXT  

Influenza Vaccine Effectiveness Among Children 6 to 59 Months of Age During 2 Influenza Seasons: A Case-Cohort Study
Szilagyi et al.
Arch Pediatr Adolesc Med 2008;162:943-951.
ABSTRACT | FULL TEXT  

Prevention of Influenza: Recommendations for Influenza Immunization of Children, 2007-2008
Committee on Infectious Diseases
Pediatrics 2008;121:e1016-e1031.
ABSTRACT | FULL TEXT  

Comparative Genomic Analyses of Seventeen Streptococcus pneumoniae Strains: Insights into the Pneumococcal Supragenome
Hiller et al.
J. Bacteriol. 2007;189:8186-8195.
ABSTRACT | FULL TEXT  

Comparative Immunogenicities of Frozen and Refrigerated Formulations of Live Attenuated Influenza Vaccine in Healthy Subjects
Block et al.
Antimicrob. Agents Chemother. 2007;51:4001-4008.
ABSTRACT | FULL TEXT  

Spectral Gradient Acoustic Reflectometry Compared With Tympanometry in Diagnosing Middle Ear Effusion in Children Aged 6 to 24 Months
Chianese et al.
Arch Pediatr Adolesc Med 2007;161:884-888.
ABSTRACT | FULL TEXT  

Childhood Influenza: Number Needed to Vaccinate to Prevent 1 Hospitalization or Outpatient Visit
Lewis et al.
Pediatrics 2007;120:467-472.
ABSTRACT | FULL TEXT  

Methodologic issues regarding the use of three observational study designs to assess influenza vaccine effectiveness
Orenstein et al.
Int J Epidemiol 2007;36:623-631.
ABSTRACT | FULL TEXT  

Vaccine Effectiveness Against Medically Attended, Laboratory-Confirmed Influenza Among Children Aged 6 to 59 Months, 2003-2004
Shuler et al.
Pediatrics 2007;119:e587-e595.
ABSTRACT | FULL TEXT  

Inactivated and Live Attenuated Influenza Vaccines in Young Children -- How Do They Compare?
Cox and Bridges
NEJM 2007;356:729-731.
FULL TEXT  

Safety, Efficacy, and Effectiveness of Cold-Adapted Influenza Vaccine-Trivalent Against Community-Acquired, Culture-Confirmed Influenza in Young Children Attending Day Care
Vesikari et al.
Pediatrics 2006;118:2298-2312.
ABSTRACT | FULL TEXT  

Influenza Vaccine Immunogenicity in 6- to 23-Month-Old Children: Are Identical Antigens Necessary for Priming?
Walter et al.
Pediatrics 2006;118:e570-e578.
ABSTRACT | FULL TEXT  

Immunization With Trivalent Inactivated Influenza Vaccine in Partially Immunized Toddlers
Englund et al.
Pediatrics 2006;118:e579-e585.
ABSTRACT | FULL TEXT  

Surveillance for Influenza Admissions Among Children Hospitalized in Canadian Immunization Monitoring Program Active Centers, 2003-2004
Moore et al.
Pediatrics 2006;118:e610-e619.
ABSTRACT | FULL TEXT  

Influenza Vaccination Effectiveness Is Not Proven in Younger Individuals at Risk
Damoiseaux et al.
Arch Intern Med 2005;165:1921-1922.
FULL TEXT  

Influenza Vaccination Effectiveness Is Not Proven in Younger Individuals at Risk--Reply
Hak et al.
Arch Intern Med 2005;165:1922-1922.
FULL TEXT  

Effectiveness of the 2003-2004 Influenza Vaccine Among Children 6 Months to 8 Years of Age, With 1 vs 2 Doses
Ritzwoller et al.
Pediatrics 2005;116:153-159.
ABSTRACT | FULL TEXT  

Respiratory illness associated with influenza and respiratory syncytial virus infection
Fleming et al.
Arch. Dis. Child. 2005;90:741-746.
ABSTRACT | FULL TEXT  

A Comparison of 2 Influenza Vaccine Schedules in 6- to 23-Month-Old Children
Englund et al.
Pediatrics 2005;115:1039-1047.
ABSTRACT | FULL TEXT  

Pharmacists' role in increasing pneumococcal and influenza vaccination
Sokos
Am J Health Syst Pharm 2005;62:367-377.
ABSTRACT | FULL TEXT  

Recommendations for Influenza Immunization of Children
Committee on Infectious Diseases
Pediatrics 2004;113:1441-1447.
ABSTRACT | FULL TEXT  

Diagnosis and Management of Acute Otitis Media
Subcommittee on Management of Acute Otitis Media
Pediatrics 2004;113:1451-1465.
ABSTRACT | FULL TEXT  

Effectiveness of Influenza Vaccine to Prevent Acute Otitis Media
Chonmaitree and Grady
JAMA 2004;291:693-693.
FULL TEXT  

Effectiveness of Influenza Vaccine to Prevent Acute Otitis Media
Heikkinen and Ruuskanen
JAMA 2004;291:692-693.
FULL TEXT  

Inactivated Influenza Vaccine Does Not Prevent AOM in Infants
JWatch General 2003;2003:5-5.
FULL TEXT  

Will Flu Vaccine Prevent Otitis Media in Young Children?
JWatch Infect. Diseases 2003;2003:3-3.
FULL TEXT