Abstract
Objectives
To investigate in a cluster-randomised trial whether a campaign with oral polio vaccine (C-OPV) reduced mortality and morbidity.
Methods
We randomised 222 village clusters under demographic surveillance to an intervention (health check and C-OPV) or control group (health check only). Children aged 0–8 months were eligible. In Cox proportional hazards models with age as the underlying timescale, we compared rates of non-accidental mortality/hospital admission (composite primary outcome) during 12 months of follow-up. Secondary analyses considered non-accidental admission and mortality as separate outcomes. Potential effect modifiers identified in prior studies including sex, season, and timing of the first routine OPV dose (OPV0, scheduled at birth) were assessed.
Results
Among 10,175 children (5288 in 111 intervention clusters/4887 in 111 control clusters), we observed 265 deaths/admissions during 7616 person-years at risk (intervention: 129; control: 136). C-OPV did not reduce the composite endpoint, hazard ratio (HR): 0.87, 95%CI: 0.68–1.12 or its separate components. C-OPV reduced the risk in children receiving OPV0<15 days of birth (HR=0.66, 95%CI: 0.46–0.95), but not in other children (p for interaction: 0.03). Interactions for other potential effect modifiers were not statistically significant.
Conclusions
C-OPV had no overall effect on mortality/admissions, but the effect differed by early priming with OPV0.
To investigate in a cluster-randomised trial whether a campaign with oral polio vaccine (C-OPV) reduced mortality and morbidity.
Methods
We randomised 222 village clusters under demographic surveillance to an intervention (health check and C-OPV) or control group (health check only). Children aged 0–8 months were eligible. In Cox proportional hazards models with age as the underlying timescale, we compared rates of non-accidental mortality/hospital admission (composite primary outcome) during 12 months of follow-up. Secondary analyses considered non-accidental admission and mortality as separate outcomes. Potential effect modifiers identified in prior studies including sex, season, and timing of the first routine OPV dose (OPV0, scheduled at birth) were assessed.
Results
Among 10,175 children (5288 in 111 intervention clusters/4887 in 111 control clusters), we observed 265 deaths/admissions during 7616 person-years at risk (intervention: 129; control: 136). C-OPV did not reduce the composite endpoint, hazard ratio (HR): 0.87, 95%CI: 0.68–1.12 or its separate components. C-OPV reduced the risk in children receiving OPV0<15 days of birth (HR=0.66, 95%CI: 0.46–0.95), but not in other children (p for interaction: 0.03). Interactions for other potential effect modifiers were not statistically significant.
Conclusions
C-OPV had no overall effect on mortality/admissions, but the effect differed by early priming with OPV0.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 106302 |
| Tidsskrift | Journal of Infection |
| Vol/bind | 89 |
| Udgave nummer | 6 |
| Antal sider | 8 |
| ISSN | 0163-4453 |
| DOI | |
| Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:This work was supported by The Danish National Research Foundation [DNRF108]; Fonden af 17-12-1981 [19024005]; Fabrikant Vilhelm Pedersen og Hustrus mindelegat as per recommendation by Novo Nordisk Fonden; K\u00F8bmand i Odense Johann og Hanne Weimann, f. Seedorffs Legat; Odense University Hospital [R34-A1797]; Augustinus Fonden [18-3343]; Aase and Ejnar Danielsens Fond [18-10-0519, 19-10-0219]; and Else og Mogens Wedell \u2013 Wedellsborgs Fond [4\u201320] ; University of Southern Denmark co-funding of PhD scholarship to LMN. ABFs research is supported through a Sapere Aude Research Leader grant from Independent Research Fund Denmark [9060-00018B] and an Ascending Investigator grant from Lundbeck Foundation [R313-2019-635].
Funding Information:
This work was supported by The Danish National Research Foundation [DNRF108]; Fonden af 17-12-1981 [19024005]; Fabrikant Vilhelm Pedersen og Hustrus mindelegat as per recommendation by Novo Nordisk Fonden; K\u00F8bmand i Odense Johann og Hanne Weimann, f. Seedorffs Legat; Odense University Hospital [R34-A1797]; Augustinus Fonden [18-3343]; Aase and Ejnar Danielsens Fond [18-10-0519, 19-10-0219]; and Else og Mogens Wedell \u2013 Wedellsborgs Fond [4-20-1]; University of Southern Denmark co-funding of PhD scholarship to LMN. ABFs research is supported through a Sapere Aude Research Leader grant from Independent Research Fund Denmark [9060-00018B] and an Ascending Investigator grant from Lundbeck Foundation [R313-2019-635].
Publisher Copyright:
© 2024 The Author(s)