Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Dec 15;11(12):e0167281.
doi: 10.1371/journal.pone.0167281. eCollection 2016.

Effect of Influenza Vaccination of Children on Infection Rate in Hutterite Communities: Follow-Up Study of a Randomized Trial

Biao Wang  1 , Margaret L Russell  2 , Lorraine Moss  1 , Kevin Fonseca  3 , David J D Earn  4   5   6 , Fred Aoki  7 , Gregory Horsman  8 , Paul Van Caeseele  9 , Khami Chokani  10 , Mark Vooght  11 , Lorne Babiuk  12 , Richard Webby  13 , Stephen D Walter  3 , Mark Loeb  1   4   5   14
Affiliations
Randomized Controlled Trial

Effect of Influenza Vaccination of Children on Infection Rate in Hutterite Communities: Follow-Up Study of a Randomized Trial

Biao Wang et al. PLoS One. .

Abstract

Background: An earlier cluster randomized controlled trial (RCT) of Hutterite colonies had shown that if more than 80% of children and adolescents were immunized with influenza vaccine there was a statistically significant reduction in laboratory-confirmed influenza among all unimmunized community members. We assessed the impact of this intervention for two additional influenza seasonal periods.

Methods: Follow-up data for two influenza seasonal periods of a cluster randomized trial involving 1053 Canadian children and adolescents aged 36 months to 15 years in Season 2 and 1014 in Season 3 who received the study vaccine, and 2805 community members in Season 2 and 2840 in Season 3 who did not receive the study vaccine. Follow-up for Season 2 began November 18, 2009 and ended April 25, 2010 while Season 3 extended from December 6, 2010 and ended May 27, 2011. Children were randomly assigned in a blinded manner according to community membership to receive either inactivated trivalent influenza vaccine or hepatitis A. The primary outcome was confirmed influenza A and B infection using RT-PCR assay. Due to the outbreak of 2009 H1N1 pandemic, data in Season 2 were excluded for analysis.

Results: For an analysis of the combined Season 1 and Season 3 data, among non-recipients (i.e., participants who did not receive study vaccines), 66 of the 2794 (2.4%) participants in the influenza vaccine colonies and 121 of the 2301 (5.3%) participants in the hepatitis A colonies had influenza confirmed by RT-PCR, for a protective effectiveness of 60% (95% CI, 6% to 83%; P = 0.04); among all study participants (i.e., including both those who received study vaccine and those who did not), 125 of the 3806 (3.3%) in the influenza vaccine colonies and 239 of the 3243 (7.4%) in the hepatitis A colonies had influenza confirmed by RT-PCR, for a protective effectiveness of 63% (95% CI, 5% to 85%; P = 0.04).

Conclusion: Immunizing children and adolescents with inactivated influenza vaccine can offer a protective effect among unimmunized community members for influenza A and B together when considered over multiple years of seasonal influenza.

Trial registration: Clinicaltrials.gov NCT00877396.

PubMed Disclaimer

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. Participant flow.
See this image and copyright information in PMC

References

    1. Nair H, Brooks WA, Katz M, Roca A, Berkley JA, Madhi SA, et al. Global burden of respiratory infections due to seasonal influenza in young children: a systematic review and meta-analysis. The Lancet. 2011;378(9807):1917–30. - PubMed
    1. Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, et al. Influenza-associated hospitalizations in the United States. Jama. 2004;292(11):1333–40. 10.1001/jama.292.11.1333 - DOI - PubMed
    1. Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. Jama. 2003;289(2):179–86. - PubMed
    1. Wenzel RP, Edmond MB. Preparing for 2009 H1N1 influenza. New England Journal of Medicine. 2009;361(20):1991–3. 10.1056/NEJMe0909666 - DOI - PubMed
    1. Lang P-O, Govind S, Mitchell WA, Siegrist C-A, Aspinall R. Vaccine effectiveness in older individuals: what has been learned from the influenza-vaccine experience. Ageing research reviews. 2011;10(3):389–95. 10.1016/j.arr.2010.09.005 - DOI - PubMed

Publication types

Substances

Associated data