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Authors
Vittrup, Dorthe Maria http://orcid.org/0000-0001-6475-5224
Laursen, Anne Cathrine Lund
Malon, Michelle
Soerensen, Jesper Kiehn
Hjort, Jakob
Buus, Soren
Svensson, Jannet
Stensballe, Lone Graff
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Funding
Funding for this research was provided by:
Innovationsfonden (VACOP-8089-00019B)
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Article History
Received: 29 April 2020
Accepted: 28 October 2020
First Online: 10 December 2020
Ethics approval and consent to participate
: Before participation, the legal guardians receive written and verbal information about trial and the most common adverse reactions after MMR vaccination. The legal guardians sign a written consent form before randomization. The informed consent is obtained by the special trained trial staff (doctors, nurses, medical students). If the child and biological mother participate in sample collection, two additional written consent forms are signed. The trial is not expected to be harmful in any way, but participants are insured by the Danish Act on the Right to Complain and Receive Compensation [CitationRef removed]. The trial is approved by the Danish Medicines Agency (EudraCT 2016-001901-18. J.no. 2016103428), the Committees on Biomedical Research Ethics (H-16041195) and by the Capital Region Data Regulation Unit (RH-2017-247, I-Suite no.: 05714). The trial is registered at ClinicalTrials.gov (NCT03780179) [CitationRef removed]. All protocol amendments are approved by the Committees on Biomedical Research Ethics before changes are implemented in the trial and the GCP-unit is notified when amendments are approved. The current version of the protocol is always available at the trial home page [CitationRef removed]. There will be made no changes in the protocol regarding the two co-primary outcomes or inclusion/exclusion criteria. All analysis plans will be deposited with the DSMB prior to removal of blinding. There will be thoroughly accounted for analyses and findings in manuscripts regarding explorative analyses. Trial results (positive, negative and inconclusive) will be published in peer reviewed journals, and the results will be available on the trial homepage. Authorships will be awarded according to Vancouver rules.
: Not applicable.
: The investigators have no financial or other competing interests. The financial sponsors have no influence on publications or termination of the trial.
