Influenza vaccine efficacy in young children attending childcare : A randomised controlled trial
© 2016 Paediatrics and Child Health Division (The Royal Australasian College of Physicians)..
AIM: Influenza causes a substantial burden in young children. Vaccine efficacy (VE) data are limited in this age group. We examined trivalent influenza vaccine (TIV) efficacy and safety in young children attending childcare.
METHODS: A double-blind, randomised controlled trial in children aged 6 to <48 months was conducted with recruitment from Sydney childcare centres in 2011. Children were randomised to receive two doses of TIV or control hepatitis A vaccine. Efficacy was evaluated against polymerase chain reaction-confirmed influenza using parent-collected nose/throat swabs during influenza-like-illness. Safety outcomes were assessed during 6 months of follow-up.
RESULTS: Fifty-seven children were allocated to influenza vaccine and 67 to control; all completed the study. The influenza attack rate was 1.8 vs 13.4% in the TIV and control groups, respectively; VE 87% (95%CI: 0-98%). For children aged 24 to <48 months, 0 vs 8 (18.6%) influenza infections occurred in the TIV and control groups respectively, giving a VE of 100% (16-100%). Efficacy was not shown in children 6 to <24 months, probably due to insufficient power. Injection site and systemic adverse events were mostly mild to moderate with no significant differences, apart from more mild diarrhoea following dose 2 in TIV recipients (11.8 vs 0%).
CONCLUSIONS: Influenza vaccine appeared efficacious in the subgroup of children aged 24 to <48 months, although caution is required due to the small number of participants. There were no serious adverse events and most parents would vaccinate again. Influenza vaccination in a childcare setting could be valuable and a larger confirmatory study would be helpful.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2017 |
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| Erschienen: |
2017 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:53 |
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| Enthalten in: |
Journal of paediatrics and child health - 53(2017), 1 vom: 05. Jan., Seite 47-54 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Li-Kim-Moy, Jean P [VerfasserIn] |
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| Links: |
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| Themen: |
Childcare |
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| Anmerkungen: |
Date Completed 02.10.2017 Date Revised 02.10.2017 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/jpc.13313 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM264033116 |
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| 245 | 1 | 0 | |a Influenza vaccine efficacy in young children attending childcare |b A randomised controlled trial |
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| 500 | |a Date Revised 02.10.2017 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2016 Paediatrics and Child Health Division (The Royal Australasian College of Physicians). | ||
| 520 | |a AIM: Influenza causes a substantial burden in young children. Vaccine efficacy (VE) data are limited in this age group. We examined trivalent influenza vaccine (TIV) efficacy and safety in young children attending childcare | ||
| 520 | |a METHODS: A double-blind, randomised controlled trial in children aged 6 to <48 months was conducted with recruitment from Sydney childcare centres in 2011. Children were randomised to receive two doses of TIV or control hepatitis A vaccine. Efficacy was evaluated against polymerase chain reaction-confirmed influenza using parent-collected nose/throat swabs during influenza-like-illness. Safety outcomes were assessed during 6 months of follow-up | ||
| 520 | |a RESULTS: Fifty-seven children were allocated to influenza vaccine and 67 to control; all completed the study. The influenza attack rate was 1.8 vs 13.4% in the TIV and control groups, respectively; VE 87% (95%CI: 0-98%). For children aged 24 to <48 months, 0 vs 8 (18.6%) influenza infections occurred in the TIV and control groups respectively, giving a VE of 100% (16-100%). Efficacy was not shown in children 6 to <24 months, probably due to insufficient power. Injection site and systemic adverse events were mostly mild to moderate with no significant differences, apart from more mild diarrhoea following dose 2 in TIV recipients (11.8 vs 0%) | ||
| 520 | |a CONCLUSIONS: Influenza vaccine appeared efficacious in the subgroup of children aged 24 to <48 months, although caution is required due to the small number of participants. There were no serious adverse events and most parents would vaccinate again. Influenza vaccination in a childcare setting could be valuable and a larger confirmatory study would be helpful | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a childcare | |
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| 650 | 4 | |a influenza | |
| 650 | 4 | |a randomised controlled trial | |
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| 650 | 7 | |a Influenza Vaccines |2 NLM | |
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| 700 | 1 | |a Heron, Leon |e verfasserin |4 aut | |
| 700 | 1 | |a Leask, Julie |e verfasserin |4 aut | |
| 700 | 1 | |a Lambert, Stephen B |e verfasserin |4 aut | |
| 700 | 1 | |a Nissen, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Sloots, Theo |e verfasserin |4 aut | |
| 700 | 1 | |a Booy, Robert |e verfasserin |4 aut | |
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