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Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh.

ABSTRACT: Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2?years in Bangladesh; a subtropical setting, where influenza circulation can be irregular.Children aged 6-23?months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio vaccine (IPV); conducted August 2010-March 2014 in Dhaka, Bangladesh. Children received two pediatric doses of vaccine, one month apart, and were followed for one year for febrile and respiratory illness. Field assistants conducted weekly home-based, active surveillance and ill children were referred to the study clinic for clinical evaluation and nasopharyngeal wash specimen collection. Analysis included all children who received a first vaccine dose and compared yearly incidence of reverse transcription polymerase chain reaction (RT-PCR)-confirmed influenza between trial arms. The VE was estimated as 1-(rate ratio of illness)?×?100%, using unadjusted Poisson regression. The trial was registered with ClinicalTrials.gov, number NCT01319955.Across four vaccination rounds, 4081 children were enrolled and randomized, contributing 2576 child-years of observation to the IIV3 arm and 2593 child-years to the IPV arm. Influenza incidence was 10 episodes/100 child-years in the IIV3 arm and 15 episodes/100 child-years in the IPV arm. Overall, the VE was 31% (95% confidence interval 18, 42%) against any RT-PCR-confirmed influenza. The VE varied by season, but was similar by influenza type/subtype and participant age and sex.Vaccination of young children with IIV3 provided a significant reduction in laboratory-confirmed influenza; however, exploration of additional influenza vaccine strategies, such as adjuvanted vaccines or standard adult vaccine doses, is warranted to find more effective influenza vaccines for young children in low-income countries.

SUBMITTER: Rolfes MA

PROVIDER: S-EPMC5723570 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh.

Rolfes Melissa A MA Goswami Doli D Sharmeen Amina Tahia AT Yeasmin Sultana S Parvin Nasrin N Nahar Kamrun K Rahman Mustafizur M Barends Marion M Ahmed Dilruba D Rahman Mohammed Ziaur MZ Bresee Joseph J Luby Stephen S Moulton Lawrence H LH Santosham Mathuram M Fry Alicia M AM Brooks W Abdullah WA

Vaccine 20171031 50

<h4>Background</h4>Few trials have evaluated influenza vaccine efficacy (VE) in young children, a group particularly vulnerable to influenza complications. We aimed to estimate VE against influenza in children aged <2 years in Bangladesh; a subtropical setting, where influenza circulation can be irregular.<h4>Methods</h4>Children aged 6-23 months were enrolled 1:1 in a parallel, double-blind, randomized controlled trial of trivalent inactivated influenza vaccine (IIV3) versus inactivated polio v ...[more]

PMID: 29100706

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Project description:BackgroundDespite widespread utilization of influenza vaccines, effectiveness (VE) has not been routinely measured in Latin America.MethodsWe used a case test-negative control design to estimate trivalent inactivated influenza VE against laboratory-confirmed influenza among hospitalized children aged 6months-5years and adults aged ≥60years which are age-groups targeted for vaccination. We sought persons with severe acute respiratory infections (SARI), hospitalized at 71 sentinel hospitals in Argentina, Brazil, Chile, Colombia, Costa Rica, El Salvador, Honduras, Panama, and Paraguay during January-December 2013. Cases had an influenza virus infection confirmed by real-time reverse transcription PCR (rRT-PCR); controls had a negative rRT-PCR result for influenza viruses. We used a two-stage random effects model to estimate pooled VE per target age-group, adjusting for the month of illness onset, age and preexisting medical conditions.ResultsWe identified 2620 SARI patients across sites: 246 influenza cases and 720 influenza-negative controls aged ≤5years and 448 cases and 1206 controls aged ≥60years. The most commonly identified subtype among participants (48%) was the influenza A(H1N1)pdm09 virus followed by influenza A(H3N2) (34%) and influenza B (18%) viruses. Among children, the adjusted VE of full vaccination (one dose for previously vaccinated or two if vaccine naïve) against any influenza virus SARI was 47% (95% confidence interval [CI]: 14-71%); VE was 58% (95% CI: 16-79%) against influenza A(H1N1)pdm09, and 65% (95% CI: -9; 89%) against influenza A(H3N2) viruses associated SARI. Crude VE of full vaccination against influenza B viruses associated SARI among children was 3% (95% CI: -150; 63). Among adults aged ≥60years, adjusted VE against any influenza SARI was 48% (95% CI: 34-60%); VE was 54% (95% CI: 37-69%) against influenza A(H1N1)pdm09, 43% (95% CI: 18-61%) against influenza A(H3N2) and 34% (95% CI: -4; 58%) against B viruses associated SARI.ConclusionInfluenza vaccine provided moderate protection against severe influenza illness among fully vaccinated young children and older adults, supporting current vaccination strategies.

Project description:BACKGROUND:Pneumonia is one of the most common complications in children hospitalized with influenza. We describe hospitalized children with influenza-associated pneumonia and associated risk indicators. METHODS:Through Emerging Infections Program Network population based surveillance, children aged <18 years hospitalized with laboratory confirmed influenza with a chest radiograph during hospitalization were identified during the 2003-2008 influenza seasons. A case with radiologically confirmed influenza-associated pneumonia was defined as a child from the surveillance area hospitalized with: (1) laboratory-confirmed influenza and (2) evidence of new pneumonia on chest radiograph during hospitalization. Hospitalized children with pneumonia were compared with those without pneumonia by univariate and multivariate analysis. RESULTS:Overall, 2992 hospitalized children with influenza with a chest radiograph were identified; 1072 (36%) had influenza-associated pneumonia.When compared with children hospitalized with influenza without pneumonia, hospitalized children with influenza-associated pneumonia were more likely to require intensive care unit admission (21% vs. 11%, P < 0.01), develop respiratory failure (11% versus 3%, P < 0.01), and die(0.9% vs. 0.3% P 0.01). In multivariate analysis, age 6 to 23 months(adjusted OR: 2.1, CI: 1.6 -2.8), age 2 to 4 years (adjusted OR: 1.7, CI:1.3-2.2), and asthma (adjusted OR: 1.4, CI: 1.1-1.8) were significantly associated with influenza-associated pneumonia. CONCLUSIONS:Hospitalized children with influenza-associated pneumonia were more likely to have a severe clinical course than other hospitalized children with influenza, and children aged 6 months to 4 years and those with asthma were more likely to have influenza-associated pneumonia.Identifying children at greater risk for influenza-associated pneumonia will inform prevention and treatment strategies targeting children at risk for influenza complications.

Dataset Information

Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh.

Publications

Efficacy of trivalent influenza vaccine against laboratory-confirmed influenza among young children in a randomized trial in Bangladesh.

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