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STORM
Sponsor study identifier
observational
2,000
0 countries
N/A
Study Start
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A two-phases study will be carried out with the following aims
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 21, 2021
Actual (reported)January 28, 2022
Actual (reported)May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Overall proportion of children fully immunized for RV and proportion of immunized children in each subgroup
32 weeks
Proportion of children receiving the first RV5 dose within 12 weeks of age
32 weeks
Proportion of children completing RV5 schedule within 32 weeks of age
32 weeks
Proportion of children receiving the co-administration RV5 + MenB
32 weeks
Proportion of children partially immunized (1 or 2 doses) or not immunized for RV in each subgroup
32 weeks
Proportion of children receiving RV5 immunization doses alone
32 weeks
Proportion of children receiving the co-administration of RV5+hexavalent/PCV
32 weeks
All children who received vaccination in their first 12 months of life between January 2018 and June 2022 in the Regional Vaccination Centers involved in the study. Children will be classified in sub-groups, according to different vaccination schedules (single or co-administration) and order of vaccine uptake.
administration of the 3 doses of Rotavirus human bovine pentavalent reassortant vaccine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
children receiving vaccination in their first year of life at one of the Vaccination Centers involved in the study
Poelaert D, Pereira P, Gardner R, Standaert B, Benninghoff B. A review of recommendations for rotavirus vaccination in Europe: Arguments for change. Vaccine. 2018 Apr 19;36(17):2243-2253. doi: 10.1016/j.vaccine.2018.02.080. Epub 2018 Mar 22.
Lo Vecchio A, Liguoro I, Dias JA, Berkley JA, Boey C, Cohen MB, Cruchet S, Salazar-Lindo E, Podder S, Sandhu B, Sherman PM, Shimizu T, Guarino A. Rotavirus immunization: Global coverage and local barriers for implementation. Vaccine. 2017 Mar 14;35(12):1637-1644. doi: 10.1016/j.vaccine.2017.01.082. Epub 2017 Feb 16.
Andrea Lo Vecchio, MD, PhD
Federico II University
First Submitted
December 21, 2021
First Posted
January 28, 2022
Study Start
May 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 2022
Contact the study team to confirm eligibility.
Foster S. Rotavirus vaccine and intussusception. J Pediatr Pharmacol Ther. 2007 Jan;12(1):4-7. doi: 10.5863/1551-6776-12.1.4. No abstract available.
O'Ryan M, Stoddard J, Toneatto D, Wassil J, Dull PM. A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program. Drugs. 2014 Jan;74(1):15-30. doi: 10.1007/s40265-013-0155-7.
DeSilva MB, Haapala J, Vazquez-Benitez G, Daley MF, Nordin JD, Klein NP, Henninger ML, Williams JTB, Hambidge SJ, Jackson ML, Donahue JG, Qian L, Lindley MC, Gee J, Weintraub ES, Kharbanda EO. Association of the COVID-19 Pandemic With Routine Childhood Vaccination Rates and Proportion Up to Date With Vaccinations Across 8 US Health Systems in the Vaccine Safety Datalink. JAMA Pediatr. 2022 Jan 1;176(1):68-77. doi: 10.1001/jamapediatrics.2021.4251.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 17, 2022
Record last verified: 2022-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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