Funding for this research was provided by:
bill and melinda gates foundation (OPP1148988)
Received: 28 June 2021
Accepted: 6 August 2021
First Online: 23 August 2021
Change Date: 16 September 2021
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1186/s12879-021-06671-x
: The study protocol (version 1.0, date 01-08-2020) was reviewed by the Research Ethics Committee of University Medical Centre Utrecht (METC Utrecht), the Netherlands (20-536). A waiver was provided for ethics review of participating Dutch sites (date 29-09-2020). For dual review purposes, the METC Utrecht reviewed the protocol with a focus on ethical conduct of research in low resource settings, using the Declaration of Helsinki and CIOMS guidelines. The study protocol was subsequently reviewed by all site investigators and comments were incorporated into the new version (version 1.2, date 15-11-2020). Ethics approval was obtained by the Institutional Review Boards of participating study sites:Afghanistan: Institutional Review Board, Ministry of Public Health: A.0121.0263;Cameroon: Cameroon Bioethics Initiative Ethics Review and Consultancy Committee: 1156;Ghana: Korle Bu Teaching Hospital Scientific and Technical Committee: KBTH-STC 00056/2021;Haiti: Comité National de Bioéthique c/o Association Médicale Haitienne: Ref 2021-19;Mozambique: Comité Nacional de Bioética para Saúde: IRB00002657; Ref:344/CNBS/21;Nepal: Ethical Review Board (ERB), Nepal Health Research Council (NHRC): 849/2020; Institutional Review Committee (IRC), Institute of Medicine, Tribhuvan University: 391/077/078; Institutional Review Committee (IRC), Kanti Children’s Hospital: 50/2020-021;Nigeria: Health Research Ethics Committee, Ahmadu Bello University Teaching Hospital Shika, Zaria, Nigeria: ABUTHHZ/HREC/H22/2021;Sudan: National Health Research Ethics Review Committee: 7-1-21;Tanzania: Muhimbili National Hospital Institutional Ethics Review Board: MNH/IRB/I/2021/39;The Gambia: Edward Francis Small Teaching Hospital Research & Ethics Committee: 27<sup>th</sup> July, 2021.The study has been registered in the Netherlands Trial Register (NL9519) on May 27, 2021.Informed consent will be obtained from the parent(s) or legal representative(s) by research staff prior to enrolment in the study.
: Not applicable.
: LJB has regular interaction with pharmaceutical and other industrial partners. He has not received personal fees or other personal benefits. UMCU has received major funding (> €100,000 per industrial partner) for investigator-initiated studies from AbbVie, MedImmune, Janssen, the Bill and Melinda Gates Foundation, Nutricia (Danone) and MeMed Diagnostics. UMCU has received major cash or in kind funding as part of the public private partnership IMI-funded RESCEU project from GSK, Novavax, Janssen, AstraZeneca, Pfizer and Sanofi. UMCU has received major funding by Julius Clinical for participating in the INFORM study sponsored by MedImmune. UMCU has received minor funding for participation in trials by Regeneron and Janssen from 2015 to 2017 (total annual estimate less than €20,000). UMCU received minor funding for consultation and invited lectures by AbbVie, MedImmune, Ablynx, Bavaria Nordic, MabXience, Novavax, Pfizer, Janssen (total annual estimate less than €20,000). LJB is the founding chairman of the ReSViNET Foundation. NIM has regular interaction with pharmaceutical and other industrial partners. She has not received personal fees or other personal benefits. HN reports grants from Innovative Medicines Initiative and National Institute of Health Research; personal fees and grants from WHO and Sanofi; and personal fees from the Bill & Melinda Gates Foundation, Janssen, Abbvie, and Reviral.GvT is involved in public private partnerships (EU Innovative Medicines Initiative consortia). She has not received personal fees or other personal benefits.