tetano
Editor, Senior Moderator
Vaccine. 2015 Jul 29. pii: S0264-410X(15)01004-X. doi: 10.1016/j.vaccine.2015.07.044. [Epub ahead of print]
[h=1]Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) cluster randomized trial: Pilot results from a household surveillance study to assess direct and indirect protection from influenza vaccination.[/h] Kwong JC[SUP]1[/SUP], Pereira JA[SUP]2[/SUP], Quach S[SUP]2[/SUP], Pellizzari R[SUP]3[/SUP], Dusome E[SUP]3[/SUP], Russell ML[SUP]4[/SUP], Hamid JS[SUP]5[/SUP], Feinberg Y[SUP]2[/SUP], Winter AL[SUP]2[/SUP], Gubbay JB[SUP]6[/SUP], Sirtonski B[SUP]2[/SUP], Moher D[SUP]2[/SUP], Sider D[SUP]2[/SUP], Finkelstein M[SUP]7[/SUP], Loeb M[SUP]8[/SUP]; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Program Delivery and Evaluation Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Children are key drivers of influenza transmission. Vaccinating school age children decreases influenza in the community.
[h=4]OBJECTIVE:[/h] To pilot-test the methods for a future trial to compare the direct and indirect benefits of inactivated influenza vaccine (IIV) vs. live attenuated influenza vaccine (LAIV) in preventing influenza infection.
[h=4]METHODS:[/h] During the 2013-14 influenza vaccination campaign, we piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario, Canada. We randomized schools on a 1:1 basis to have students receive IIV or LAIV. We invited a subset of vaccinated students and their households to participate in a surveillance sub-study, which involved completing daily symptom diaries during influenza season and collecting mid-turbinate swabs from symptomatic individuals to detect influenza infection. The main outcome measure was confirmed influenza infection using a real-time reverse transcriptase polymerase chain reaction (PCR) assay.
[h=4]RESULTS:[/h] One hundred and nineteen households (166 students and 293 household members) participated. During 15 weeks of surveillance, we detected 22 episodes of PCR-confirmed influenza (21 influenza A/H1N1 and 1 influenza B). The incidence of influenza per 1000 person-days was 1.24 (95% CI, 0.40-2.89) for IIV-vaccinated students, compared to 0.13 (95% CI, 0.003-0.72) for LAIV-vaccinated students; the incidence rate ratio was 0.10 (95% CI, 0.002-0.94). Similarly, the incidence of influenza per 1000 person-days was 1.33 (95% CI, 0.64-2.44) for IIV household members, compared to 0.47 (95% CI, 0.17-1.03) for LAIV household members; the incidence rate ratio was 0.36 (95% CI, 0.11-1.08). The overall incidence rate ratio (combining students and household members) was 0.27 (95% CI, 0.09-0.69).
[h=4]CONCLUSIONS:[/h] Household surveillance involving participant monitoring and reporting of symptoms and self-collection of mid-turbinate swabs is feasible. A larger study is required to validate the suggestion that vaccinating children with LAIV might confer more protection against influenza for both children and their household contacts, compared to IIV.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov NCT01995851.
Copyright ? 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Canada; Influenza; Influenza vaccines; Live vaccines; Ontario
PMID: 26232348 [PubMed - as supplied by publisher] Free full text
[h=1]Randomized evaluation of live attenuated vs. inactivated influenza vaccines in schools (RELATIVES) cluster randomized trial: Pilot results from a household surveillance study to assess direct and indirect protection from influenza vaccination.[/h] Kwong JC[SUP]1[/SUP], Pereira JA[SUP]2[/SUP], Quach S[SUP]2[/SUP], Pellizzari R[SUP]3[/SUP], Dusome E[SUP]3[/SUP], Russell ML[SUP]4[/SUP], Hamid JS[SUP]5[/SUP], Feinberg Y[SUP]2[/SUP], Winter AL[SUP]2[/SUP], Gubbay JB[SUP]6[/SUP], Sirtonski B[SUP]2[/SUP], Moher D[SUP]2[/SUP], Sider D[SUP]2[/SUP], Finkelstein M[SUP]7[/SUP], Loeb M[SUP]8[/SUP]; Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) Program Delivery and Evaluation Group.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Children are key drivers of influenza transmission. Vaccinating school age children decreases influenza in the community.
[h=4]OBJECTIVE:[/h] To pilot-test the methods for a future trial to compare the direct and indirect benefits of inactivated influenza vaccine (IIV) vs. live attenuated influenza vaccine (LAIV) in preventing influenza infection.
[h=4]METHODS:[/h] During the 2013-14 influenza vaccination campaign, we piloted an open-label cluster randomized trial involving 10 elementary schools in Peterborough, Ontario, Canada. We randomized schools on a 1:1 basis to have students receive IIV or LAIV. We invited a subset of vaccinated students and their households to participate in a surveillance sub-study, which involved completing daily symptom diaries during influenza season and collecting mid-turbinate swabs from symptomatic individuals to detect influenza infection. The main outcome measure was confirmed influenza infection using a real-time reverse transcriptase polymerase chain reaction (PCR) assay.
[h=4]RESULTS:[/h] One hundred and nineteen households (166 students and 293 household members) participated. During 15 weeks of surveillance, we detected 22 episodes of PCR-confirmed influenza (21 influenza A/H1N1 and 1 influenza B). The incidence of influenza per 1000 person-days was 1.24 (95% CI, 0.40-2.89) for IIV-vaccinated students, compared to 0.13 (95% CI, 0.003-0.72) for LAIV-vaccinated students; the incidence rate ratio was 0.10 (95% CI, 0.002-0.94). Similarly, the incidence of influenza per 1000 person-days was 1.33 (95% CI, 0.64-2.44) for IIV household members, compared to 0.47 (95% CI, 0.17-1.03) for LAIV household members; the incidence rate ratio was 0.36 (95% CI, 0.11-1.08). The overall incidence rate ratio (combining students and household members) was 0.27 (95% CI, 0.09-0.69).
[h=4]CONCLUSIONS:[/h] Household surveillance involving participant monitoring and reporting of symptoms and self-collection of mid-turbinate swabs is feasible. A larger study is required to validate the suggestion that vaccinating children with LAIV might confer more protection against influenza for both children and their household contacts, compared to IIV.
[h=4]TRIAL REGISTRATION:[/h] ClinicalTrials.gov NCT01995851.
Copyright ? 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
[h=4]KEYWORDS:[/h] Canada; Influenza; Influenza vaccines; Live vaccines; Ontario
PMID: 26232348 [PubMed - as supplied by publisher] Free full text