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dc.contributor.authorRiddell, C.A.
dc.contributor.authorBhat, N.
dc.contributor.authorBont, L.J.
dc.date.accessioned2019-06-21T18:46:28Z
dc.date.available2019-06-21T18:46:28Z
dc.date.issued2018
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85057047664&doi=10.1016%2fj.vaccine.2018.10.041&partnerID=40&md5=9326d6a028073d4bdbef707589dd655e
dc.identifier.urihttp://hdl.handle.net/10713/9720
dc.description.abstractBackground: Early RSV illness is associated with wheeze-associated disorders in childhood. Candidate respiratory syncytial virus (RSV) vaccines may prevent acute RSV illness in infants. We investigated the feasibility of maternal RSV vaccine trials to demonstrate reductions in recurrent childhood wheezing in general paediatric populations. Methods: We calculated vaccine trial effect sizes that depended on vaccine efficacy, allocation ratio, rate of early severe RSV illness, risk of recurrent wheezing at age 3, and increased risk of RSV infection on recurrent wheezing. Model inputs came from systematic reviews and meta-analyses. For each combination of inputs, we estimated the sample size required to detect the effect of vaccination on recurrent wheezing. Results: There were 81 scenarios with 1:1 allocation ratio. Risk ratios between vaccination and recurrent wheezing ranged from 0.9 to 1.0 for 70% of the scenarios. Among the 57 more plausible scenarios, the lowest sample size required to detect significant reductions in recurrent wheezing was 6196 mother-infant pairs per trial arm; however, 75% and 47% of plausible scenarios required >31,060 and >100,000 mother-infant pairs per trial arm, respectively. Studies with asthma endpoints at age 5 will likely need to be larger. Discussion: Clinical efficacy trials of candidate maternal RSV vaccines undertaken for licensure are unlikely to demonstrate an effect on recurrent wheezing illness due to the large sample sizes likely needed to demonstrate a significant effect. Further efforts are needed to plan for alternative study designs to estimate the impact of maternal RSV vaccine programs on recurrent childhood wheezing in general populations. Copyright 2018 The Author(s)en_US
dc.description.urihttps://dx.doi.org/10.1016/j.vaccine.2018.10.041en_US
dc.language.isoen-USen_US
dc.publisherElsevier Ltden_US
dc.relation.ispartofVaccine
dc.subjectAsthmaen_US
dc.subjectGlobal healthen_US
dc.subjectPregnanten_US
dc.subjectRespiratory syncytial virusen_US
dc.subjectVaccineen_US
dc.subjectWheezeen_US
dc.titleInforming randomized clinical trials of respiratory syncytial virus vaccination during pregnancy to prevent recurrent childhood wheezing: A sample size analysisen_US
dc.typeArticleen_US
dc.identifier.doi10.1016/j.vaccine.2018.10.041
dc.identifier.pmid30473186


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