Evidence map›Paper›PMID 39158584›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Safety and Immunogenicity of an mRNA-1273 Booster in Children.

Vladimir Berthaud, C Buddy Creech, Christina A Rostad, Quito Carr, Liberation de Leon, Monika Dietrich, Anil Gupta, David Javita, Sharon Nachman, Swetha Pinninti and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04796896 (A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04796896 phase2 / phase3completednot on this map

A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

TypeinterventionalSponsorModernaTX, Inc.Ran2021 to 2024Enrolled11,942ConditionsSARS-CoV-2ArmsmRNA-1273, Placebo, mRNA-1273.214
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Vladimir BerthaudMeharry Medical College-Division of Infectious Diseases, Clinical and Translational Research Center, Nashville, Tennessee, USA.ORCID 0000-0001-5585-4853
C Buddy CreechVanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Christina A RostadDepartment of Medicine, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Quito CarrMedPharmics, LLC-Albuquerque, Albuquerque, New Mexico, USA.
Liberation de LeonCenter for Clinical Trials, LLC, Paramount, California, USA.
Monika DietrichDepartment of Pediatric Infectious Disease, Tulane University School of Medicine, New Orleans, Louisiana, USA.
Anil GuptaDr. Anil K. Gupta Medicine Professional Corporation, Toronto, Ontario, Canada.
David JavitaProhealth Research Center, Doral, Florida, USA.
Sharon NachmanRenaissance School of Medicine, SUNY Stony Brook, Stony Brook, New York, USA.ORCID 0000-0002-3419-9471
Swetha PinnintiDivision of Pediatric Infectious Diseases, University of Alabama at Birmingham/Children's of Alabama, Birmingham, Alabama, USA.
Mobeen RathoreUniversity of Florida Center for HIV/AIDS Research, Education and Service (UF CARES), Jacksonville, Florida, USA.
Carina A RodriguezDivision of Pediatric Infectious Diseases, University of South Florida, Morsani College of Medicine, Tampa, Florida, USA.
Katherine LuzuriagaProgram in Molecular Medicine, UMass Chan Medical School, Worcester, Massachusetts, USA.
William TownerDepartment of Infectious Diseases, Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, USA.
Anne YeakeyBioPoint Contracting, Wake Forest, North Carolina, USA.
Mollie BrownModerna, Inc, Cambridge, Massachusetts, USA.
Xiaoping ZhaoModerna, Inc, Cambridge, Massachusetts, USA.
Weiping DengModerna, Inc, Cambridge, Massachusetts, USA.
Wenqin XuModerna, Inc, Cambridge, Massachusetts, USA.
Honghong ZhouModerna, Inc, Cambridge, Massachusetts, USA.
Bethany GirardModerna, Inc, Cambridge, Massachusetts, USA.
Roxanne KellyModerna, Inc, Cambridge, Massachusetts, USA.
Karen SlobodCambridge ID & Immunology Consulting, LLC, Somerville, Massachusetts, USA.
Evan J AndersonDepartment of Medicine, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Georgia, USA.
Rituparna DasModerna, Inc, Cambridge, Massachusetts, USA.
Jacqueline MillerModerna, Inc, Cambridge, Massachusetts, USA.
Sabine Schnyder GhamloushModerna, Inc, Cambridge, Massachusetts, USA.

Funding

VTEU SupplementUM1AI148689 · NIAID · UNIVERSITY OF MARYLAND BALTIMORE · PI Karen L. Kotloff · 2020 to 2026
$52.7M
Vanderbilt Vaccine and Treatment Evaluation Unit - KidCOVEUM1AI148452 · NIAID · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Clarence Buddy Creech · 2020 to 2026
$51.3M
Vaccine and Treatment Evaluation Units - DMID 21-0012UM1AI148576 · NIAID · EMORY UNIVERSITY · PI Nadine Georges Rouphael, Carlos del Rio · 2020 to 2026
$41.7M
University of Massachusetts Center for Clinical Science and Translational SupplementUL1TR001453 · NCATS · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI LUZURIAGA, KATHERINE F · 2015 to 2024
$39.0M
Vaccine and Treatment Evaluation Units (VTEU)-DMID 21-0004UM1AI148575 · NIAID · BAYLOR COLLEGE OF MEDICINE · PI HANA M EL SAHLY · 2020 to 2026
$29.4M
University of Rochester Vaccine and Treatment Evaluation Unit (VTEU)-mRNA-1273-P204 Moderna Pediatric StudyUM1AI148450 · NIAID · UNIVERSITY OF ROCHESTER · PI Angela Ramona Branche, Ann R Falsey · 2020 to 2026
$20.6M
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
Neuro HPA Project 1U54AG062334 · NIA · EMORY UNIVERSITY · PI Ighovwerha Ofotokun · 2018 to 2026
$12.2M
Emory R38 Research Training ProgramR38AI174306 · NIAID · EMORY UNIVERSITY · PI Nadine Georges Rouphael · 2023 to 2026
$1.4M
Administration for Strategic Preparedness and ResponseBiomedical Advanced Research and Development Authority 75A50120C00034HHSNational Institute of Allergy and Infectious DiseasesNational Institutes of Health, National Center for Advancing Translational Sciences UL1TR001453NCATS NIH HHS UL1 TR001453NIAID NIH HHS R38 AI174306NIAID NIH HHS UM1 AI148372NIAID NIH HHS UM1 AI148450NIAID NIH HHS UM1 AI148452NIAID NIH HHS UM1 AI148575NIAID NIH HHS UM1 AI148576NIAID NIH HHS UM1 AI148689NIA NIH HHS U54 AG062334NIH HHS UM1AI148576
6 · The paper itself

Abstract

backgroundA 2-dose mRNA-1273 primary series in children aged 6 months-5 years (25 µg) and 6-11 years (50 µg) 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.

methodsAn mRNA-1273 booster dose (10 µg for children aged 6 months-5 years; 25 µg for children aged 6-11 years; age groups based on participant age at enrollment) was administered ≥6 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 (18-25 years) from the pivotal efficacy study. Data were collected from March 2022 to June 2023.

resultsOverall, 153 (6 months-5 years) and 2519 (6-11 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.

conclusionsSafety and immunogenicity data support administration of an mRNA-1273 booster dose in children aged 6 months to 11 years. CLINICAL TRIALS REGISTRATION: NCT04796896 (Clinicaltrials.gov).

Indexed as

2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19Immunization, SecondarySARS-CoV-2AdolescentAdultChildChild, PreschoolCOVID-19 VaccinesFemaleHumansImmunogenicity, VaccineInfantMale2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccinesbooster dosechildrenCOVID-19mRNA-1273SARS-CoV-2

Identifiers

PMID39158584
PMCPMC11650855

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.