Document is current

Article History

Received: 27 October 2020

Accepted: 27 April 2021

First Online: 30 May 2021

Declarations

:

: The study protocol was submitted and approved by the IMR Research Management Committee and registered within the National Medical Research Register (NMRR-18-636-39710). The protocol has been also approved by the Medical Ethics research committee (MREC) on Dec 2019 (KKM/NIHSEC/P19 – 2362-7).There is no compensation planned as the products are expected to be safe. However, in the case of an event which might be linked to the interventions, the subject will be referred to health care facilities supported by the Ministry of Health.In Malaysia, each locality (cluster) has its own management team. Before the start of the intervention, meetings with the head of management are organized to explain the purposes of the trial. Written informed consent (supplementary material, appendix 5) to carry out the vector control activities is sought after the briefing.Collection of epidemiological data, i.e. dengue incidence data will not seek consent at individual level because the data are from existing surveillance and under the 2017 the WHO Guidelines on Ethical Issues in Public Health Surveillance specifically guideline number 12, informed consent is not invariably necessary for surveillance*. All personal data concerning dengue cases will remain the property of the Malaysian Ministry of Health and kept strictly confidential. Only anonymized data will be shared with the department of Statistics in Lyon-France. The study will not provide medical care during or after the trial. The primary endpoint of the trial comes from the existing dengue surveillance system.*WHO guidelines on ethical issues in public health surveillance. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. ISBN 978-92-4-151265-7

: We do not intend to publish images of people, or identifiable data, in manuscripts deriving from the trial.

: RS and TM are remunerated by and hold shares in In2Care BV. FB and FS are employees of Bayer. Other authors do not have any competing interest to declare.