{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T14:26:41Z","timestamp":1785940001932,"version":"3.56.0"},"reference-count":28,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2024,8,19]],"date-time":"2024-08-19T00:00:00Z","timestamp":1724025600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100012737","name":"Department of Health and Human Services","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100012737","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100021704","name":"Administration for Strategic Preparedness and Response","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100021704","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["75A50120C00034"],"award-info":[{"award-number":["75A50120C00034"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148576"],"award-info":[{"award-number":["UM1AI148576"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148452"],"award-info":[{"award-number":["UM1AI148452"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148689"],"award-info":[{"award-number":["UM1AI148689"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148450"],"award-info":[{"award-number":["UM1AI148450"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148372"],"award-info":[{"award-number":["UM1AI148372"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI148575"],"award-info":[{"award-number":["UM1AI148575"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Institutes of Health, National Center for Advancing Translational Sciences","award":["UL1TR001453"],"award-info":[{"award-number":["UL1TR001453"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,12,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>A 2-dose mRNA-1273 primary series in children aged 6 months\u20135 years (25 \u00b5g) and 6\u201311 years (50 \u00b5g) had an acceptable safety profile and was immunogenic in the phase 2\/3 KidCOVE study. We present data from KidCOVE participants who received an mRNA-1273 booster dose.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>An mRNA-1273 booster dose (10 \u00b5g for children aged 6 months\u20135 years; 25 \u00b5g for children aged 6\u201311 years; age groups based on participant age at enrollment) was administered \u22656 months after primary series completion. The primary safety objective was the safety and reactogenicity of an mRNA-1273 booster dose. The primary immunogenicity objective was to infer efficacy of an mRNA-1273 booster dose by establishing noninferiority of neutralizing antibody (nAb) responses after a booster in children versus nAb responses observed after the mRNA-1273 primary series in young adults (18\u201325 years) from the pivotal efficacy study. Data were collected from March 2022 to June 2023.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 153 (6 months\u20135 years) and 2519 (6\u201311 years) participants received an mRNA-1273 booster dose (median age at receipt of booster: 2 and 10 years, respectively). The booster dose safety profile was generally consistent with that of the primary series in children; no new safety concerns were identified. An mRNA-1273 booster dose elicited robust nAb responses against ancestral SARS-CoV-2 among children and met prespecified noninferiority success criteria versus responses observed after the primary series in young adults.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Safety and immunogenicity data support administration of an mRNA-1273 booster dose in children aged 6 months to 11 years.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT04796896 (Clinicaltrials.gov).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciae420","type":"journal-article","created":{"date-parts":[[2024,8,16]],"date-time":"2024-08-16T22:26:04Z","timestamp":1723847164000},"page":"1524-1532","source":"Crossref","is-referenced-by-count":10,"title":["Safety and Immunogenicity of an mRNA-1273 Booster in Children"],"prefix":"10.1093","volume":"79","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5585-4853","authenticated-orcid":false,"given":"Vladimir","family":"Berthaud","sequence":"first","affiliation":[{"name":"Meharry Medical College\u2014Division of Infectious Diseases, Clinical and Translational Research Center , Nashville, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C Buddy","family":"Creech","sequence":"additional","affiliation":[{"name":"Vanderbilt Vaccine Research Program, Vanderbilt University Medical Center , Nashville, Tennessee ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina A","family":"Rostad","sequence":"additional","affiliation":[{"name":"Department of Medicine, Emory University School of Medicine and Children's Healthcare of Atlanta , Atlanta, Georgia ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Quito","family":"Carr","sequence":"additional","affiliation":[{"name":"MedPharmics, LLC\u2014Albuquerque , Albuquerque, New Mexico ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liberation","family":"de Leon","sequence":"additional","affiliation":[{"name":"Center for Clinical Trials, LLC , Paramount, California ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Monika","family":"Dietrich","sequence":"additional","affiliation":[{"name":"Department of Pediatric Infectious Disease, Tulane University School of Medicine , New Orleans, Louisiana ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anil","family":"Gupta","sequence":"additional","affiliation":[{"name":"Dr. Anil K. Gupta Medicine Professional Corporation , Toronto, Ontario ,","place":["Canada"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Javita","sequence":"additional","affiliation":[{"name":"Prohealth Research Center , Doral, Florida ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3419-9471","authenticated-orcid":false,"given":"Sharon","family":"Nachman","sequence":"additional","affiliation":[{"name":"Renaissance School of Medicine, SUNY Stony Brook , Stony Brook, New York ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swetha","family":"Pinninti","sequence":"additional","affiliation":[{"name":"Division of Pediatric Infectious Diseases, University of Alabama at Birmingham\/Children's of Alabama , Birmingham, Alabama 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