Overall effect of a campaign with measles vaccine on the composite outcome mortality or hospital admission: A cluster-randomized trial among children aged 9-59 months in rural Guinea-Bissau
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Overall effect of a campaign with measles vaccine on the composite outcome mortality or hospital admission : A cluster-randomized trial among children aged 9-59 months in rural Guinea-Bissau. / Varma, Anshu; Thysen, Sanne M; Martins, Justiniano S D; Nanque, Line M; Jensen, Aksel K G; Fisker, Ane B.
I: International Journal of Infectious Diseases, Bind 134, 2023, s. 23-30.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Overall effect of a campaign with measles vaccine on the composite outcome mortality or hospital admission
T2 - A cluster-randomized trial among children aged 9-59 months in rural Guinea-Bissau
AU - Varma, Anshu
AU - Thysen, Sanne M
AU - Martins, Justiniano S D
AU - Nanque, Line M
AU - Jensen, Aksel K G
AU - Fisker, Ane B
N1 - Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.
PY - 2023
Y1 - 2023
N2 - OBJECTIVES: Campaigns with measles vaccine (C-MV) are conducted to eradicate measles, but prior studies indicate that MV reduces non-measles mortality and hospital admissions too. We hypothesized that C-MV reduces death/hospital admission by 30%.METHODS: Between 2016-2019, we conducted a non-blinded cluster-randomized trial randomizing village clusters in rural Guinea-Bissau to a C-MV targeting children aged 9-59 months. In Cox proportional hazards models, we assessed the effect of C-MV, obtaining hazard ratios (HR) for the composite outcome (death/hospital admission). We also examined potential effect modifiers.RESULTS: Among 18,411 children (9636 in 111 intervention clusters/8775 in 110 control clusters), 379 events occurred (208 intervention/171 control) during a median follow-up period of 22 months. C-MV did not reduce the composite outcome (HR 1.12, 95% confidence interval 0.88-1.41). Mortality among enrolled children (5.3 intervention and 4.6 control, per 1000 person-years) was approximately half the pre-trial mortality rate (11.1 intervention and 8.9 control, per 1000 person-years). Neither planned nor explorative analyses of potential effect modifiers explained the contrasting results to prior studies.CONCLUSION: C-MV did not reduce overall mortality or hospital admission. This might be explained by changes in disease patterns, baseline differences in health status, and/or modifying effects of other campaigns during follow-up.
AB - OBJECTIVES: Campaigns with measles vaccine (C-MV) are conducted to eradicate measles, but prior studies indicate that MV reduces non-measles mortality and hospital admissions too. We hypothesized that C-MV reduces death/hospital admission by 30%.METHODS: Between 2016-2019, we conducted a non-blinded cluster-randomized trial randomizing village clusters in rural Guinea-Bissau to a C-MV targeting children aged 9-59 months. In Cox proportional hazards models, we assessed the effect of C-MV, obtaining hazard ratios (HR) for the composite outcome (death/hospital admission). We also examined potential effect modifiers.RESULTS: Among 18,411 children (9636 in 111 intervention clusters/8775 in 110 control clusters), 379 events occurred (208 intervention/171 control) during a median follow-up period of 22 months. C-MV did not reduce the composite outcome (HR 1.12, 95% confidence interval 0.88-1.41). Mortality among enrolled children (5.3 intervention and 4.6 control, per 1000 person-years) was approximately half the pre-trial mortality rate (11.1 intervention and 8.9 control, per 1000 person-years). Neither planned nor explorative analyses of potential effect modifiers explained the contrasting results to prior studies.CONCLUSION: C-MV did not reduce overall mortality or hospital admission. This might be explained by changes in disease patterns, baseline differences in health status, and/or modifying effects of other campaigns during follow-up.
U2 - 10.1016/j.ijid.2023.05.011
DO - 10.1016/j.ijid.2023.05.011
M3 - Journal article
C2 - 37182547
VL - 134
SP - 23
EP - 30
JO - International Journal of Infectious Diseases
JF - International Journal of Infectious Diseases
SN - 1201-9712
ER -
ID: 359224538