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. 2022 Sep 14;23:775. doi: 10.1186/s13063-022-06493-5
Title {1} A phase 1/2, single-centre, double-blind, double-dummy, randomized, active-controlled, age de-escalation trial to assess the safety, tolerability and immunogenicity of a measles and rubella vaccine delivered by a microneedle patch in healthy adults (18 to 40 years), measles and rubella vaccine-primed toddlers (15 to 18 months) and measles and rubella vaccine-naïve infants (9 to 10 months) in The Gambia. [Measles and Rubella Vaccine Microneedle Patch Phase 1/2 Age De-escalation Trial].
Trial registration {2a and 2b}.

Pan-African Clinical Trials Registry: 202008836432905.

ClinicalTrials.gov: NCT04394689

Protocol version {3} Version 3.1 26 July 2021
Funding {4} Bill & Melinda Gates Foundation through a grant provided to Micron Biomedical, Inc.
Author details {5a}

Ikechukwu Adigweme1, Edem Akpalu1, Mohammed Yisa1, Simon Donkor1, Lamin B Jarju1, Baba Danso1, Anthony Mendy1, David Jeffries1, Andrew Bruce1, Michael Royals2, James L Goodson3, Mark R Prausnitz2, Devin McAllister2, Paul A Rota4, Sebastien Henry2, Ed Clarke1*.

* Corresponding Author: Ed.Clarke@lshtm.ac.uk; (+220) 7039732.

1Vaccines and Immunity Theme, MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Boulevard, Fajara, PO Box 273, Banjul, The Gambia

2Micron Biomedical, Inc, 311 Ferst Dr, NW, Suite L1309, Atlanta, GA 30332, United States of America.

3Accelerated Disease Control Branch, Global Immunization Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America

4Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America

Name and contact information for the trial sponsor {5b} Sebastien Henry, Micron Biomedical, Inc. 311 Ferst Dr, NW, Suite L1309, Atlanta, GA 30332, USA, shenry@micronbiomedical.com
Role of sponsor {5c} The sponsor (Micron Biomedical, Inc) worked with the MRCG investigators to develop the design of the trial and the data collection tools used and will be involved in the interpretation of the data, in report writing and in decisions to submit the data for publication. The funder (Bill & Melinda Gates Foundation) was not involved in the study design or conduct and will not be involved in data interpretation or publication.
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